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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Approved Gas Masks 20-Jan-04

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, MD 20850

JAN 20 2004



Mr. Robert Higginbotham
General Manager
Approved Gas Masks
Box 9509
San Diego, California 92169

Dear Mr. Higginbotham:

The Food and Drug Administration (FDA) has obtained information from your Internet web sites, <http://www.approvedgasmasks.com.>, and <http://www.nbcsafety.com>, that reveals a serious regulatory problem involving the Affinity Foldable FR 200 - N95 Mask; the North Half-Mask Respirator; the SARS protection-pak, which includes Affinity N95 Masks, Flex-Vinyl medical grade gloves and Atwater Carey Waterless Hand Cleaner; and the SARS Deluxe protection-pak, which includes North 5500 P100 Half Mask, P100 filters, N95 Affinity FR200 Premium Foldable Masks, Medical Grade Latex Free Gloves, and Atwater Carey Waterless Hand Cleaner. These products are commercially distributed by your firm.

The names of the protection-paks, "SARS protection pak" and "SARS Deluxe protection pak," recommend or suggest use of the products for protection against SARS. Similarly, your web sites states that the Affinity Foldable FR200 - N95 Mask "provides N95 protection against SARS," the North Half-Mask respirator "is ideal for SARS," and the Flex-Vinyl Gloves are "effective for SARS protection." Consequently, these products are intended for use in the cure, mitigation, treatment, or prevention of disease within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. 321(h), and are medical devices that are subject to the Act's requirements for premarket approval or clearance by FDA.

Our records do not show that approval or clearance has been obtained for the products listed above to prevent SARS transmission or for any other SARS-related indication. Accordingly, these products are adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)), in that they are class III devices under section 513(f) (21 U.S.C. 360c(f)) and you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) (21 U.S.C. 360e(a)) or an approved application for investigational device exemption under section 520(g) (21 U.S.C. 360j(g)). The products are also misbranded under section 502(o) (21 U.S.C. 352(o)), because a notice or other information respecting them was not provided to the FDA as required by section 510(k) (21 U.S.C. 360(k)). For a product requiring premarket approval (as opposed to clearance), the notification required by section 510(k) is deemed to be satisfied when a PMA is pending before the agency. 21 CFR 807.81(b).

This serious violation of the law may result in the FDA taking regulatory action without further notice to you. Such action can include, but is not limited to, seizing your product inventory, obtaining a court injunction against further marketing your products, or seeking civil money penalties. Also, Federal agencies are informed about the Warning Letters we issue, such as this one, so that they may consider this information when awarding government contracts.

FDA acknowledges that the SARS infection'control recommendations issued by the Centers for Disease Control and Prevention (CDC) endorse the use of personal protective equipment including N-9 filtering disposable respirators, eye protection articles, gowns, gloves, and surgical masks. CDC limited these recommendations to specific health care and community settings, however, and did not suggest use of personal protective equipment by the general population, or by individuals who will travel to or have returned from areas affected by SARS. In fact, CDC specifically did not recommend the routine use of personal protective equipment, even in public areas of SARS-affected countries. Moreover, CDC's recommendations are based on preliminary information concerning the means by which SARS spreads, and many products (e.g., air purifiers) are not endorsed in any setting by CDC. No devices have been cleared or approved by FDA specifically to prevent the transmission of SARS.

Please respond in writing, within 15 days of receiving this letter, by explaining the specific steps you have taken to correct this violation and to assure that similar violations will not occur. If you need additional time, please explain the reason for the delay and advise us when you expect to respond. Also, we request that you provide us with the name and address of, and the name of a contact person for, the manufacturers of the Affinity N95 Mask, Flex-Vinyl Medical Grade Gloves, North 5500 Half-Mask, latex-free medical grade gloves, and the Silver Shield gloves and glove liners.

Please address your response to Ms. Betty Collins, Director, Division of Enforcement A, Office of Compliance, Center for Devices and Radiological Health, Food and Drug Administration, 2098 Gaither Road (HFZ-320), Rockville, Maryland 20850. If you have any questions concerning the contents of this letter, you may contact Carolyn Niebauer, Chief, General Hospital Devices Branch, or Diane Goldsberry, Technical Information Specialist, by phone at (301) 594-4618 or by facsimile at (301) 594-4638.

You should understand that there are many FDA requirements pertaining to the manufacture and marketing of medical devices. This letter pertains only to the issue of premarket clearance or approval for your devices and does not necessarily address other obligations you have under the Act. You may obtain general information about FDA requirements for medical devices by contacting our Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041 or through the Internet at <http://www.fda.gov>.

Finally, in addition to the Act, you may be subject to the Federal Trade Commission Act, which is administered by the Federal Trade Commission (FTC). A copy of this letter is being forwarded to the FTC.

Sincerely yours,


Timothy A. Ulatowski
Office of Compliance
Center for Devices and
Radiological Health