The Food and Drug Administration (FDA) recently published a new guidance document to help expand the availability of surgical apparel, including gowns, hoods, and surgical & patient examination gloves, in response to the COVID-19 public health emergency. The guidance document, titled: Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency is available here.

Due to the current COVID-19 health crisis, the FDA is allowing the following modifications for Minimal-to-Low barrier protection devices and Moderate-to-High Barrier Protection devices. The devices covered under the scope of this guidance document include gowns, other apparel, and gloves, as regulated by FDA when they meet the definition of a device under section 201(h) of the FD&C Act.

Minimal-to-Low Barrier protection refers to:

• ANSI/AAMI PB7011, 12 Level 1 protection or equivalent; or
• ANSI/AAMI PB70 Level 2 protection or equivalent.
• These devices include: non-surgical gowns, shoe covers, caps, and surgical suits that are Class-I devices exempt from premarket notification under section 510(k) of the FD&C Act however subject to the following [pursuant to 21 CFR 878.4040(b)(2)]:
  • Registration and Listing requirements in 21 CFR 807
  • Quality System Regulation requirements in 21 CFR 820
  • Reports of corrections and removals in 21 CFR Part 806
  • Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR Part 801.2
• However, the FDA does not intend to object to the distribution and use of gowns not intended for use as “surgical gowns” and other low-to-minimal barrier protection surgical apparel that does not comply with the regulatory requirements, as stated above, where the gowns and apparel do not create an undue risk in light of the public health emergency
• If the devices meet the following criteria, the FDA deems that they do not present an undue risk:
  • The product includes labeling that accurately describes the product as a “gown,” or “toga,” or other apparel (as opposed to a “surgical gown,” or “surgical toga”) and includes a list of the body contacting materials (which does not include any drugs or biologics)
  • The product includes labeling that makes recommendations that would reduce sufficiently the risk of use, for example, recommendations against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected, use in a clinical setting where Level 3 or 4 protection is warranted, and use in the presence of high-intensity heat source or flammable gas
  • The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses

Moderate-to-High Barrier protection refers to:

• ANSI/AAMI PB70 Level 3 protection or equivalent; or
• ANSI/AAMI PB70 Level 4 protection or equivalent
• These products include: surgical gowns intended for use in healthcare settings and surgical isolation gowns are used when there is a medium to high risk of contamination and need for larger critical zones than traditional surgical gowns
• Surgical gowns are considered Class-II devices, as per 21 CFR 878.4040, with Special Controls and require:
  • 510(k) premarket notification as per 21 CFR 807.81
  • Registration and listing under 21 CFR 807
  • Unique Identification Requirements (UDI) under 21 CFR Part 830 and 21 CFR 801.2

• However, the FDA does not intend to object to the distribution and use of ANSI/AAMI PB70 Level 3 moderate-to-high barrier protection surgical gowns that do not comply with the regulatory requirements, as stated above, when they do not create an undue risk – provided they meet the following:
  • The product:
    • Meets liquid barrier protection at Level 3 or higher, consistent with ANSI/AAMI PB70 for the critical zone areas
    • Meets the Class I or higher flammability standards (16 CFR Part 1610)
    • Has demonstrated sterility in a surgical setting
  • The product is labeled accurately describing its sterility status (sterile or non-sterile), including any sterilization method used, barrier protection as Level 3, flammability classification (Class I or Class II), and a list of the body contacting materials
  • The product is labeled with general statements and makes recommendations that would sufficiently reduce the risk of use, for example, a general statement about devices that have not been cleared by FDA, recommendations against use when FDA-cleared surgical gowns are available, and recommendations against the use of non-sterile products in surgical settings
  • The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection; uses for infection prevention or reduction, or is labeled as having ANSI/AAMI PB70 Level 4 liquid barrier protection

Gloves

Gloves are considered medical devices when their intended use is for medical purposes, such as prevention of infectious disease transmission (including uses related to COVID-19).

Patient Examination Gloves (Class I (reserved), which are subject to pre-market notification (510(k)), and general controls

• The FDA does not intend to object to the distribution of patient examination gloves that do not comply with the regulatory requirements if they do not create an undue risk – provided they meet the following:
  • The product:
    • is labeled accurately describing it as an “unpowdered glove” (as opposed to a surgeon’s or patient examination glove);
    • is labeled accurately describing its sterility status when individually packaged (non-sterile);
    • does not claim to be free of a specific material (e.g., latex-free), and;
    • includes a list of the body contacting materials.
  • The product is labeled with general statements and makes recommendations that sufficiently reduces the risk of use
  • The product is not intended for any use that would create an undue risk in light of the public health emergency

Surgeon’s Gloves (Class 1 (reserved), which are subject to pre-market authorization and general controls

• The FDA does not intend to object to the distribution of Surgeon’s Examination gloves that do not comply with the regulatory requirements if they do not create an undue risk – provided they meet the following:
  • The product meets the standard specification consistent with the consensus standard ASTM D3577: Standard Specification for Rubber Surgical Gloves
  • The product is labeled accurately describing it as an “unpowdered glove” (as opposed to a surgeon’s or patient examination glove)
  • The product is labeled accurately describing its sterility status when individually packaged (non-sterile)
  • The product does not claim to be free of a specific material (e.g., latex-free)
  • The product includes a list of the body contacting materials
  • The product includes labeling with general statements and makes recommendations that would reduce sufficiently the risk of use, for example, a general statement about devices that have not been cleared by FDA and recommendations against use when FDA-cleared surgeon’s gloves are available; and
  • The product is not intended for any use that would create an undue risk in light of the public health emergency

The FDA recognizes that when alternatives, such as FDA-cleared gowns, other surgical apparel, and/or gloves, are unavailable, individuals, including healthcare professionals, might improvise personal protective equipment (PPE). FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared gowns, other surgical apparel, and/or gloves, are available.

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