Head to Toe: Summary of FDA COVID-19 Guidance Relating to Gowns, Other Apparel, and Gloves

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Along with the US Food and Drug Administration’s guidance addressing shortages of masks and respirators, FDA has released guidance aimed at increasing the supply of other personal protective equipment important in the fight against COVID-19: medical gowns, other apparel, and gloves. 

FDA has a very broad definition of “medical device” that can cover, inter alia, gowns, shoes, shoe coverings, caps, head coverings, other apparel, and gloves used by surgeons or healthcare providers for medical purposes, such as for protecting against health hazards and exposure.[1] Because of shortages in such apparel and gloves, however, FDA issued Guidance, “Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency” to permit the use of “improvised personal protective equipment” when FDA-cleared products are not available. 

The Guidance is directed to specific (1) “minimal-to-low” barrier protection apparel that is already exempt from FDA pre-market notification requirements; (2) “moderate-to-high” barrier protection surgical apparel; and (3) patient examination and surgical gloves.

Minimal-to-Low Barrier Protection Products

Non-surgical gowns and protection apparel like booties, surgical caps, and other equipment that provide only a minimal or low barrier of protection are considered Class I exempt medical devices. Under standard FDA regulations, such products are exempt from FDA’s pre-market notification process, but still must meet other general controls. The Guidance waives enforcement of certain of those controls to expand the availability of such low-risk equipment. Specifically, FDA will not object to the distribution and use of certain low-to-minimal barrier products that fail to meet the following regulations: 21 CFR Part 807 (registration and listing requirements); 21 CFR Part 820 (quality system regulation requirements); 21 CFR Part 806 (reports of corrections and removals); or 21 CFR Parts 830 and 801.20 (unique device identification requirements). 

To qualify under the Guidance, the Class I exempt products must comply with a series of labeling requirements relating to, e.g., the type of product, materials, and include certain “use”/“do not use” instructions. The Guidance also covers only the following Class I exempt medical devices:

For Protection of Head/Face:

• Surgical helmets (Product Code FXZ, Class I (exempt))
• Surgical caps (FYF, Class I (exempt))

For Protection of Body: 

• Non-surgical isolation gown (OEA, Class I (exempt))
• Surgical suits (FXO, Class I (exempt))
• Surgical dress (FYE, Class I (exempt))
• Surgical apparel accessory (LYU, Class I (exempt))

For Protection of Feet: 

• Conductive shoe and shoe cover (Product Code BWP, Class I (exempt))
• Operating-room shoes (FXW, Class I (exempt))
• Operating-room shoe covers (FXP, Class I (exempt))

For Protection of Hands:

• Finger Cot (LZB, Class I (exempt))

Moderate-to-High Barrier Protection Surgical Gowns

The Guidance also provides the relaxation of enforcement of FDA regulations for certain moderate-to-high barrier protection products, such as surgical gowns. At issue are products that operating room personnel can wear to protect against contamination with bodily fluids, microorganisms, or other particulates. These products are Class II devices and, under normal conditions, are subject to premarket notification requirements.

The Guidance provides that during the COVID-19 emergency, the FDA will not object to the distribution and use of certain surgical gowns and products that were not submitted for premarket approval or that fail to satisfy 21 CFR Part 807 (registration and listing requirements) or 21 CFR Parts 830 and 801.20 (unique device identification requirements).

To qualify under the Guidance, the surgical apparel must meet liquid barrier protection, flammability, and sterility (if used for surgery) standards and requirements. Such apparel also must comply with a series of labeling requirements relating to its ability to meet said liquid barrier, flammability, and sterility standards. Finally, the products are subject to labeling requirements relating to, e.g., the type of product and materials, and must include certain “use”/“do not use” instructions.

The Guidance specifically covers only the following Class II surgical apparel:

For Protection of Head/Face:

• Surgical hoods (FXY, Class II)

For Protection of Body: 

• Surgical isolation gown (FYC, Class II)
• Patient gown (FYB, Class II)
• Surgical gown/toga (FYA, Class II)

Gloves

The FDA Guidance also provides for the relaxation of enforcement regarding certain gloves, both those for patient examination and for surgical uses. The gloves identified in the Guidance are in Class I (reserved) and, unlike Class I exempt products, require compliance with the FDA’s premarket approval regulations. 

For patient-examination gloves, FDA will not object to the distribution and use of patient-examination gloves that were not submitted for premarket approval or that fail to satisfy 21 CFR Part 807 (registration and listing requirements); 21 CFR Part 820 (quality system regulation requirements); 21 CFR Part 806 (reports of corrections and removals); or 21 CFR Parts 830 and 801.20 (unique device identification requirements). The patient-examination gloves are subject to labeling requirements relating to, e.g., the type of product and materials used and whether the gloves are sterile. The gloves further cannot claim to be “free” of any specific material (e.g. latex free). Certain “use”/“do not use” instructions are also required.

For surgeon’s gloves, FDA will not object to the distribution and use of surgeon’s gloves that were not submitted for premarket approval or that fail to satisfy 21 CFR Part 807 (registration and listing requirements) or 21 CFR Parts 830 and 801.20 (unique device identification requirements). The surgeon’s gloves must meet the glove standard specifications under ASTM D3577. Such gloves also are subject to labeling requirements relating, e.g., to the type of product and materials used and whether the gloves are sterile. The gloves further cannot claim to be “free” of any specific material (e.g. latex free). Certain “use”/“do not use” instructions are also required.

The Guidance specifically covers only the following glove categories:

• Patient examination glove (FMC, Class I (reserved))
• Latex patient examination glove (LYY, Class I (reserved))
• Polymer patient examination glove (LZA, Class I (reserved))
• Vinyl patient examination glove (LYZ, Class I (reserved))
• Powder-free polychloroprene patient examination glove (OPC, Class I (reserved))
• Specialty patient examination glove (LZC, Class I (reserved))
• Powder-free guayle rubber examination glove (OIG, Class I (reserved))
• Radiation attenuating medical glove (OPH, Class I (reserved))
• Surgeon’s gloves (KGO, Class I (reserved))
• Powder-free non-natural rubber latex surgeon’s gloves (OPA, Class I (reserved))

To ensure compliance with FDA’s Guidance for gowns, other apparel, and gloves, Seyfarth Shaw strongly recommends legal review of the labeling and, depending on the product, testing and control compliance.

As the COVID-19 crisis evolves, Seyfarth Shaw attorneys are closely monitoring the FDA’s reactions to the situation. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our Resource Center for more information.

 

[1] See 21 U.S.C. § 321(h). As the Guidance makes clear, gowns and apparel that are not used for medical purposes, such as those used for research and development, construction, or manufacturing, are not subject to FDA regulations relating to medical devices, which include marketing authorization, etc. To determine whether the device is for a medical use, FDA reviews whether the product is labeled or intended for use by a health care professional or in a health care environment and whether the products include any biological, anti-microbial, anti-viral, or drug agents.