Refusal Actions by FDA as Recorded in OASIS



    Manufacturer FEI: 3004636618
    Manufacturer Name: Ge Healthcare Technologies
    Manufacturer address line 1: Munzinger Str 3
    Manufacturer address line 2:
    Manufacturer City: Freiburg
    Manufacturer Province/state:
    Manufacturer Country: Germany
    Product code: 80F--MI
    Importers product description: NEEDLE, HYPODERMIC, SINGLE LUMEN;;
    Refusal date: 13-NOV-2008
    FDA_District: BLT-DO
    Entry/doc/line/sfx: 336-6720272-8/1/1/
    Carrier: UNITED AIR LINES,INC.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): REGISTERED


    Manufacturer FEI: 3005034090
    Manufacturer Name: Ningbo Free Zone Chain Medical Prod
    Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
    Manufacturer address line 2:
    Manufacturer City: Ningbo
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80F--QM
    Importers product description: 4" STERILE CONFORMING BANDAGE
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 551-6390460-5/10/1/
    Carrier: NEW PENN MOTOR EXPRESS INC
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               REGISTERED


    Manufacturer FEI: 3005034090
    Manufacturer Name: Ningbo Free Zone Chain Medical Prod
    Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
    Manufacturer address line 2:
    Manufacturer City: Ningbo
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80F--QM
    Importers product description: 6" STERILE CONFORMING BANDAGE
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 551-6390460-5/11/1/
    Carrier: NEW PENN MOTOR EXPRESS INC
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               REGISTERED


    Manufacturer FEI: 3005034090
    Manufacturer Name: Ningbo Free Zone Chain Medical Prod
    Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
    Manufacturer address line 2:
    Manufacturer City: Ningbo
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80F--QM
    Importers product description: 2" STERILE CONFORMING BANDAGE
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 551-6390460-5/12/1/
    Carrier: NEW PENN MOTOR EXPRESS INC
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               REGISTERED


    Manufacturer FEI: 3005034090
    Manufacturer Name: Ningbo Free Zone Chain Medical Prod
    Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
    Manufacturer address line 2:
    Manufacturer City: Ningbo
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80F--QM
    Importers product description: 3" STERILE CONFORMING BANDAGE
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 551-6390460-5/13/1/
    Carrier: NEW PENN MOTOR EXPRESS INC
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               REGISTERED


    Manufacturer FEI: 3006737271
    Manufacturer Name: WENZHOU CAREMED MEDICAL TECHNOLOGY CO., LTD.
    Manufacturer address line 1: ZHIGUANG INDUSTRIAL PARK
    Manufacturer address line 2: LIUSHI
    Manufacturer City: YUEQING, ZHEJIANG PRO
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80F--QM
    Importers product description: 2" COHESIVE BANDAGE
    Refusal date: 25-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 551-7746021-4/1/1/
    Carrier: NEW PENN MOTOR EXPRESS INC
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               REGISTERED


    Manufacturer FEI: 3005704039
    Manufacturer Name: Chain Medical
    Manufacturer address line 1: 72 Mayuan Road
    Manufacturer address line 2:
    Manufacturer City: Ningbo
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80F--QM
    Importers product description: 40X40X56 TRIANGULAR BANDAGE
    Refusal date: 25-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 551-7746021-4/2/1/
    Carrier: NEW PENN MOTOR EXPRESS INC
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): REGISTERED


    Manufacturer FEI: 3005034090
    Manufacturer Name: Ningbo Free Zone Chain Medical Prod
    Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
    Manufacturer address line 2:
    Manufacturer City: Ningbo
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80F--QM
    Importers product description: 2" STERILE CONFORMING BANDAGE
    Refusal date: 25-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 551-7746021-4/3/1/
    Carrier: NEW PENN MOTOR EXPRESS INC
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): REGISTERED


    Manufacturer FEI: 3005034090
    Manufacturer Name: Ningbo Free Zone Chain Medical Prod
    Manufacturer address line 1: Room B3-B4, Fl10, No.72 Ma Yuan Rd.
    Manufacturer address line 2:
    Manufacturer City: Ningbo
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80F--QM
    Importers product description: 3" STERILE CONFORMING BANDAGE
    Refusal date: 25-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 551-7746021-4/4/1/
    Carrier: NEW PENN MOTOR EXPRESS INC
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): REGISTERED


    Manufacturer FEI: 3006375968
    Manufacturer Name: Bba Beyment Bogazici Alboy Magazaci
    Manufacturer address line 1: Moramin Is Mrk B4
    Manufacturer address line 2:
    Manufacturer City: Istanbul
    Manufacturer Province/state:
    Manufacturer Country: Turkey
    Product code: 80K--GX
    Importers product description: BAND AID
    Refusal date: 10-NOV-2008
    FDA_District: SJN-DO
    Entry/doc/line/sfx: 256-0147330-6/1/1/
    Carrier: IBERIA - LINEAS AEREAS DE ESP
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3007188359
    Manufacturer Name: Nycomed
    Manufacturer address line 1: 60 Baylis Rd
    Manufacturer address line 2:
    Manufacturer City: Melville
    Manufacturer Province/state: NY
    Manufacturer Country: United States
    Product code: 80K--MJ
    Importers product description: SURGILUBE LUBRICANT
    Refusal date: 21-NOV-2008
    FDA_District: SEA-DO
    Entry/doc/line/sfx: M76-8813261-3/1/1/
    Carrier: PUROLATOR COURIER LTD
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): REGISTERED


    Manufacturer FEI: 3007087417
    Manufacturer Name: Vaigel Inc
    Manufacturer address line 1: 8025 Haskell Ave
    Manufacturer address line 2:
    Manufacturer City: Van Nuys
    Manufacturer Province/state: CA
    Manufacturer Country: United States
    Product code: 80K--MJ
    Importers product description: VIGEL ENHANCE SENSUAL PLEASURE
    Refusal date: 21-NOV-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: UPS-0520558-1/1/1/A
    Carrier: ALL NIPPON AIRWAYS COMPANY, L
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               FALSE


    Manufacturer FEI: 3007087417
    Manufacturer Name: Vaigel Inc
    Manufacturer address line 1: 8025 Haskell Ave
    Manufacturer address line 2:
    Manufacturer City: Van Nuys
    Manufacturer Province/state: CA
    Manufacturer Country: United States
    Product code: 80K--MJ
    Importers product description: VIGEL ENHANCE FEMALE AROUSAL
    Refusal date: 21-NOV-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: UPS-0520558-1/1/1/B
    Carrier: ALL NIPPON AIRWAYS COMPANY, L
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               FALSE


    Manufacturer FEI: 3006316319
    Manufacturer Name: Medrad Inc
    Manufacturer address line 1: 100 Global View Dr
    Manufacturer address line 2:
    Manufacturer City: Warrendale
    Manufacturer Province/state: PA
    Manufacturer Country: United States
    Product code: 80K--YZ
    Importers product description: DISPOSABLE SYRINGE FOR EXPORT ONLY
    Refusal date: 21-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM9-8011240-1/1/1/
    Carrier: BRITISH AIRWAYS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 5833
    Manufacturer Name: Eppendorf Geratebau Netheler + Hinz Gmbh
    Manufacturer address line 1: Barkhausenweg 1
    Manufacturer address line 2:
    Manufacturer City: Hamburg
    Manufacturer Province/state:
    Manufacturer Country: Germany
    Product code: 80L--DQ
    Importers product description: LAB EQ FDA WE NEED REFUSAL NOTICE A.S.A.P. CARGO IS FOR EXPO
    Refusal date: 05-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: EQ6-0008396-6/1/1/
    Carrier: ALITALIA-LINEE AEREE ITALIANE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3007209937
    Manufacturer Name: Bio Rad
    Manufacturer address line 1: Rue Gustave Eiffel Et Rue
    Manufacturer address line 2:
    Manufacturer City: Mitry Mory
    Manufacturer Province/state:
    Manufacturer Country: France
    Product code: 80L--DQ
    Importers product description: LAB EQ FDA PLS ISSUE REFUSAL NOTICE A.S.A.P. FOR EXPORT TYPE
    Refusal date: 06-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: EQ6-0008475-8/1/1/
    Carrier: BRITISH AIRWAYS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3007209937
    Manufacturer Name: Bio Rad
    Manufacturer address line 1: Rue Gustave Eiffel Et Rue
    Manufacturer address line 2:
    Manufacturer City: Mitry Mory
    Manufacturer Province/state:
    Manufacturer Country: France
    Product code: 80L--DQ
    Importers product description: LAB EQ FDA PLS ISSUE REFUSAL NOTICE A.S.A.P. FOR EXPORT TYPE
    Refusal date: 06-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: EQ6-0008476-6/1/1/
    Carrier: BRITISH AIRWAYS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3007194827
    Manufacturer Name: Chung Wha Medicos Co.,Ltd
    Manufacturer address line 1: Cmc Blgd 3f 463-8 Goonja Dong
    Manufacturer address line 2:
    Manufacturer City: Seoul
    Manufacturer Province/state:
    Manufacturer Country: Korea, Republic Of (South)
    Product code: 80L--DQ
    Importers product description: SKINCARE MACHINE
    Refusal date: 26-NOV-2008
    FDA_District: LOS-DO
    Entry/doc/line/sfx: AN1-0570413-2/1/1/
    Carrier: KOREAN AIR LINES CO. INC.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO TAG


    Manufacturer FEI: 3006722480
    Manufacturer Name: Jiangsu Cureguard Glove Co.,Ltd
    Manufacturer address line 1: No.65, Shenzhen Road North
    Manufacturer address line 2:
    Manufacturer City: Suqian City
    Manufacturer Province/state: Jiangsu
    Manufacturer Country: China
    Product code: 80L--YY
    Importers product description: VINYL EXAM GLOVES
    Refusal date: 13-NOV-2008
    FDA_District: NYK-DO
    Entry/doc/line/sfx: DP4-0449805-8/1/1/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: Yes
    FDA record of private lab sample analysis: No
    Charge(s): HOLES


    Manufacturer FEI: 3001146957
    Manufacturer Name: Shijiazhuang Brethern Plastic Co., Ltd. (Factory)
    Manufacturer address line 1: No. 205 Zhonghua South Street
    Manufacturer address line 2:
    Manufacturer City: Shijiazhuang, Hebei
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--YZ
    Importers product description: VINYL MEDICAL EXAM GLOVES POWDER FREE
    Refusal date: 03-NOV-2008
    FDA_District: BLT-DO
    Entry/doc/line/sfx: E41-0059409-9/1/1/
    Carrier: EVERGREEN LINE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: Yes
    Charge(s): HOLES


    Manufacturer FEI: 3006540060
    Manufacturer Name: ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD.
    Manufacturer address line 1: ZHANGDIAN DISTRICT
    Manufacturer address line 2:
    Manufacturer City: SHANGDONG
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--YZ
    Importers product description: VINYL EXAMAINTION GLOVES POWDER FREE
    Refusal date: 18-NOV-2008
    FDA_District: NYK-DO
    Entry/doc/line/sfx: TJE-0809129-0/1/1/
    Carrier: MITSUI O S K LINES LTD
    Bill of Lading:
    FDA sample analysis: Yes
    FDA record of private lab sample analysis: No
    Charge(s): HOLES


    Manufacturer FEI: 7895
    Manufacturer Name: Kaohsiung Brothers Products Corp.
    Manufacturer address line 1: 23, Kooshan 3rd Road  (OFFICE)
    Manufacturer address line 2: P.O. BOX 1-150
    Manufacturer City: Kaohsiung
    Manufacturer Province/state:
    Manufacturer Country: Taiwan
    Product code: 80L--YZ
    Importers product description: VINYL EXAM GLOVES
    Refusal date: 20-NOV-2008
    FDA_District: ATL-DO
    Entry/doc/line/sfx: 315-7317206-6/1/1/
    Carrier: ZIM ISRAEL NAVIGATION CO LTD
    Bill of Lading:
    FDA sample analysis: Yes
    FDA record of private lab sample analysis: No
    Charge(s): HOLES


    Manufacturer FEI: 3006543087
    Manufacturer Name: GLORMED COLOMBIA S.A.
    Manufacturer address line 1: MAMONAL KM. 9 ZONA FRANCA
    Manufacturer address line 2:
    Manufacturer City: CARTAGENA
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 80L--YZ
    Importers product description: GLOVE, PATIENT EXAMINATION, VINYL;;
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: BEA-9050888-4/1/1/
    Carrier: MITSUI O S K LINES LTD
    Bill of Lading:
    FDA sample analysis: Yes
    FDA record of private lab sample analysis: No
    Charge(s): HOLES


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN HEAVYWEIGHT NITRILE UNFLOCKED GLOVES (SIZE 8); STYLE#
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/2/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN HEAVYWEIGHT NITRILE UNFLOCKED GLOVES (SIZE 7); STYLE#
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/3/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN HEAVYWEIGHT NITRILE UNFLOCKED GLOVES (SIZE 9); STYLE#
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/4/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN NITRILE UNFLOCKED GLOVES (SIZE 10); STYLE# LA142G/10ZJ
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/5/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN NITRILE FLOCKED GLOVES (SIZE 9); STYLE# LA172G/9
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/6/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN NITRILE FLOCKED GLOVES (SIZE 9); STYLE# LA172G/9ZJ
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/7/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN NITRILE UNFLOCKED GLOVES (SIZE 9); STYLE# LA142G/9ZJ
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/8/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN NITRILE FLOCKED GLOVES (SIZE 11); STYLE# LA132G/11
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/9/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN NITRILE FLOCKED GLOVES (SIZE 10); STYLE# LA132G/10
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/10/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN HEAVYWEIGHT NITRILE UNFLOCKED GLOVES (SIZE 8); STYLE#
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/11/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN HEAVYWEIGHT NITRILE UNFLOCKED GLOVES (SIZE 9); STYLE#
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/13/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN NITRILE FLOCKED GLOVES (SIZE 9); STYLE# LA132G/9
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/14/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3005548589
    Manufacturer Name: Beijing Huateng Rubber Plastic and Latex Products Co., LTD
    Manufacturer address line 1: Ciqu Industrial Zone
    Manufacturer address line 2: Tongzhou District
    Manufacturer City: Beijing
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 80L--ZA
    Importers product description: GREEN HEAVYWEIGHT NITRILE UNFLOCKED GLOVES (SIZE 11); STYLE#
    Refusal date: 14-NOV-2008
    FDA_District: NWE-DO
    Entry/doc/line/sfx: 336-8913858-7/1/15/
    Carrier: CHINA OCEAN SHIPPING COMPANY
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)


    Manufacturer FEI: 3006479675
    Manufacturer Name: Desarrollos Tecnicos Gtri
    Manufacturer address line 1: Luis I, 71 Nave 29
    Manufacturer address line 2:
    Manufacturer City: Madrid
    Manufacturer Province/state:
    Manufacturer Country: Spain
    Product code: 80M--TV
    Importers product description: Desktop Needle Incinerator
    Refusal date: 19-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: JF7-0070641-5/1/1/
    Carrier: IBERIA - LINEAS AEREAS DE ESP
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): REGISTERED
               NO PMA/PDP