5. Premarket Notification 510(k)
A Premarket Notification (510(k)) is a submission of information sent to the FDA to obtain marketing clearance for a medical device. A 510(k) submission is a comparison of a new device with a “predicate” device. A predicate device is a legally marketed device to which equivalence is established. The 510(k) documents that the new finished medical glove you wish to market is as safe and effective as a legally marketed medical glove in the U.S. You cannot market medical gloves in the U.S. until you receive a letter from FDA declaring the gloves substantially equivalent (21 CFR 807.100(a)(5)).
ASTM International (ASTM) has developed a number of medical glove related standards. CDRH has officially recognized many of these standards for premarket clearance purposes. Conformance to these standards is voluntary. (See Chapter 10 of this guidance for more information on voluntary standards.)
You should provide physical parameter and biocompatibility data obtained from tests and inspection of packaged and sterilized gloves (finished gloves). The 510(k) submitter should keep this documentation on file.
You can find detailed instructions for a 510(k) submission for patient examination gloves and surgeon’s gloves in Chapters 6 and 7, respectively.
A 510(k) submitter may choose from three types of Premarket Notification 510(k) submissions for marketing clearance: Traditional, Special, and Abbreviated. The
traditional 510(k) method is the original submission as provided in 21 CFR part 807. There are two optional alternatives to the Traditional 510(k) method for obtaining 510(k) marketing clearance under certain instances: Special 510(k) and Abbreviated 510(k). The Special 510(k) Device Modification utilizes certain aspects of the Quality System regulation to streamline 510(k) review; the Abbreviated 510(k) relies on the use of guidance documents, special controls (for class II devices), and recognized standards to facilitate 510(k) review. Additional information about the 510(k) submission process is available at "Premarket Notification 510(k)".
As of October 1, 2002, FDA charges a fee to review 510(k) submissions. This submission fee applies to Traditional, Abbreviated, and Special 510(k)s. FDA should receive payment on or before the time you submit the 510(k) submission. If the submitter has not paid all fees owed, FDA will consider the submission incomplete and will not accept it for filing. You should direct questions regarding user fees to the Division of Small Manufacturers, International and Consumer Assistance at 240-276-3150.
Additional information, including the current review fee for a 510(k), is available at "Premarket Notification [510(k)] Review Fees".
For medical gloves, the indication for use is the same as the intended use. The information, data, and labeling claims in the entire 510(k) submission should support and agree with the Indications for Use statement. CDRH will attach the Indications for Use statement to the substantial equivalence letter that is sent to the submitter when the 510(k) is cleared.
We recommend one of the following statements or equivalent text as an indication for use statement.
Powdered Examination Gloves
A powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Examination Gloves
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powdered surgeon's gloves
A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Powder-free surgeon's gloves
A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
For a special purpose glove, you should include additional text in the Indications for Use statement that covers the additional function of the glove as stated in your labeling. You should also indicate that it is an over-the-counter device.
Medical glove 510(k) submissions should include samples of the package labeling. Labeling does not need to be in final printed format; you may submit draft labeling. The final labeling should be consistent with the draft labeling you submitted in the 510(k). The final labeling should agree with your drawings for labeling and preprinted packaging in your Quality System device master record (21 CFR 820.181), and comply with other applicable requirements in the Act and regulations.
Labeling, labeling claims, and data should be consistent with the Indications for Use statement. If you make any specific claims for your gloves, you should include data to substantiate the claims in this format or in identified attachments. Puffery, ambiguous, or unsubstantiated claims such as super strong, extra thick, micro thin, super sensitive, or low protein, are not appropriate.
POWDER FOR EXAMINATION GLOVES
Powder used for lubricating examination gloves should meet the United States Pharmacopoeia (U.S.P.) monograph for absorbable dusting powder or be equivalent in terms of safety and effectiveness. The 510(k) should include the type, specifications, and source of powder or other donning lubricant used on the gloves. You should not use talc, cotton flock, and other non-absorbable materials as a lubricating, dusting, or donning powder. Lycopodium (club moss spores) and ground pine pollen are toxic and are not acceptable as powder on or in medical gloves.
POWDER FOR SURGEON’S GLOVES
Absorbable donning or dusting powder from powder manufacturers that have obtained an approved new drug application (NDA), abbreviated new drug application (ANDA), or premarket approval application (PMA) must be used on powdered surgeon’s gloves (21 CFR 878.4480). A list of firms with approved NDAs or PMAs for Surgical Dusting Powder is available at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm . Use Product Code “KGP” as the search term.
Premarket Notification 510(k) submissions for coated medical gloves should contain complete information about the composition and intended purpose of the coating used, e.g., ease of donning. The draft labeling should also contain any special or additional claims for the gloves due to the presence of the coating, e.g., “easier to don.”
For gloves that are labeled as sterile, FDA recommends that you provide sterilization information in accordance with “ Updated 510(k) Sterility Review Guidance K90-1”. You should sterilize the gloves to a sterility assurance level (SAL) of 1 x 10 -6 using a sterilization cycle that has been validated in accordance with the Quality Systems requirements, 21 CFR part 820.
In accordance with 21 CFR 807.87(h), the Premarket Notification 510(k) submission must include either a 510(k) Summary or a 510(k) Statement:
510(k) Summary is a summary of the 510(k) in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence (21 CFR 807.92).
510(k) Statement is a certification that the 510(k) holder will provide a copy of the entire 510(k) submission, excluding patient identifiers, trade secret, and confidential commercial information, to any person within 30 days of a written request (21 CFR 807.93). You may not charge requesters for a copy of the 510(k) submission.
You should make the choice between the 510(k) Summary and 510(k) Statement before you submit the 510(k). You may elect to change your choice between the summary or statement before FDA determines substantial equivalence. FDA will accept Summaries or amendments to Summaries until FDA issues a determination of substantial equivalence. After the determination, you cannot modify the 510(k) Summary or change your choice of a 510(k) Summary or 510(k) Statement. See 21 CFR 807.92(a).
Further information regarding the content of the 510(k) Summary or 510(k) Statement.
We provide the following supplemental information for 510(k) Summaries for medical gloves.
21 CFR 807.92(a)(2)
Trade name - ABC ® Latex Examination Gloves
Common name - exam gloves
Classification name - patient examination glove
21 CFR 807.92(a)(4)
You should describe any variations from the predicate device. For special purpose gloves, describe the special features.
21 CFR 807.92(a)(6)
We recommend that you include a brief table of the measured parameters of your finished gloves compared to FDA-recognized consensus standards or equivalent methods. You should include data that show conformance with FDA biocompatibility, pinhole, powder residual and other specifications and recommendations and any other parameter for which you have a labeling claim.
21 CFR 807.92(b)(2)
Clinical data is usually not needed for medical glove 510(k) submissions.
21 CFR 807.92(b)(3)
We recommend that you state that your gloves meet the FDA-recognized consensus standard or equivalent method and meet your labeling claims and pinhole acceptable quality level (AQL) as shown by the data in 21 CFR 807.92(a)(6).
The statement should be on a separate letterhead page, clearly identified as “510(k) statement,” signed by the certifier, not a consultant to the 510(k) submitter, and should include the specific language provided in 21 CFR 807.93.
If you make a change to your gloves that significantly affects safety or effectiveness of the gloves, you must submit a new and complete 510(k) ( 21 CFR 807.81(a)(3)) . Examples of changes that may require a new 510(k) include adding or deleting powder; adding color, fragrance, or a claim to the labeling; or modifying an important process. FDA usually does not require a new 510(k) if a manufacturer only does more of an existing process, such as extra leaching or washing, and makes no claim or mention of this change on the product labeling.
Changes to patient examination gloves, labeling, packaging, and processes should meet the Quality System regulation at 21 CFR 820.40 and 820.70(b). You should make changes to surgeon’s gloves, labeling, packaging, and processes in accordance with Quality System regulation at 21 CFR 820.30, 820.40, and 820.70(b). If you do not need a new 510(k), you should document your decision and how you arrived at it in the device master record (21 CFR 820.181).
We recommend the following guidance document for additional information:
You may submit a “Special” 510(k) submission for a modification to an existing glove 510(k) held by the same submitter.
A 510(k) may be bought, sold, or transferred. FDA is not involved in transfers of ownership. The new owner should maintain information documenting the transfer of ownership of a 510(k), including any legal transactions that took place, in its 510(k) files.
The new owner should list the device according to 21 CFR part 807 and the previous owner should delete its device listing. Upon inspection of the firm or upon entry of glove shipments into the U.S., FDA may request a review of documentation of ownership. If the owner is not able to provide the information, FDA may request the owner to submit a 510(k). You may not distribute the gloves until FDA clears the new submission.
Note that neither a registration nor a listing proves 510(k) ownership. The new owner of the 510(k) should maintain files with documentation proving ownership of the 510(k).
To avoid problems when importing a device with a transferred 510(k) ownership, FDA recommends that a copy of the specific information relating to the ownership sale or transfer accompany all shipments to the United States. This could be a simple one-page document detailing the transfer transaction.