FDA Issues Enforcement Policy for Gowns, Other Apparel, and Gloves

This Policy can be found here. FDA intends for this Policy to remain in effect for the duration of the COVID-19 public health emergency.

There are many products marketed in the US as gowns, gloves, and other apparel that offer a range of protection against potential health hazards. Such products are regulated by FDA when they intended for a medical purpose.

The specific types of applicable devices and associated product codes are listed on pp. 3-4 of the Policy.

Gowns

Non-surgical Gowns and Minimal-to-Low Barrier Protection Surgical Apparel

Under FDA’s conventional regulatory framework, a gown that is not intended for use as a “surgical gown” is a class I device that is exempt from premarket notification (“510(k)”) requirements. Minimal-to-low barrier protection surgical apparel such as shoe covers, caps, and surgical suits are also class 1 510(k)-exempt devices.

Although already 510(k)-exempt, non-surgical gowns and other minimal-to-low barrier apparel are typically subject to Registration and Listing, Quality System Regulation, Unique Device Identification, and certain reporting requirements. However, in an effort to expand the availability of these products during the COVID-19 public health emergency, FDA has announced that it does not intend to enforce these requirements for these devices so long as the product, including its labeling, does not create undue risk. Examples of such labeling can be found at p. 7 of the Policy, and includes the omission of any claims regarding antiviral, antimicrobial protection, or use for infection prevention or reduction uses.

Moderate-to-High Barrier Protection Surgical Gowns

FDA considers “surgical gowns” to include gowns that claim moderate to high level barrier protection -- such as ANSI/AAMI PB 70 Level 3 or 4 -- to be a higher risk device than those that claim minimal or low levels of barrier protection. Such gowns are considered class II devices, and, as such, are typically subject to 510(k) requirements. as well as FDA’s general controls.

Under this new Policy, however, FDA does not intend to object to the distribution and use of surgical gowns that fail to comply with the 510(k) requirement, or the Registration and Listing, and Unique Device Identification requirements. In order to be deemed exempt from those requirements, the product must satisfy liquid barrier protection at Level 3 or higher; meet the Class 1 or II flammability standards per 16 CFR part 1616; and be demonstrated to be sterile if intended for use in surgical settings. In addition, the product labeling must comply with the requirements listed at p. 9 of the Policy.

Gloves

Patient Examination Gloves

The patient examination glove subject to this Policy is a disposable device intended for a medical purpose that is worn by the examiner to prevent contamination between the patient and examiner. This type of glove includes only residual powder from manufacturing.

As a Class I device, patient examination gloves are typically subject to FDA’s 510(k) requirements, in addition to Registration and Listing, Quality System Regulation, Unique Device Identification, and certain reporting requirements. However, in an effort to expand the availability of these products during the COVID-19 public health emergency, FDA has announced that it does not intend to enforce any of those requirements for these devices so long as the product labeling does not create undue risk. Examples of criteria for such labeling can be found at pp.10-11 of the Policy.

Surgeon’s Gloves

The type of surgeon’s glove subject to this Policy is a device intended to be worn by operating room personnel to protect a surgical wound from contamination. Similar to a patient examination glove, this type of glove includes only residual powder from manufacturing.

This type of glove is regulated by FDA as a type of Class 1 device that is typically subject to FDA’s 510(k) requirements, as well as FDA’s Establishment Registration and Listing, and Unique Device Identification requirements. However, FDA does not intend to object to the distribution and use of surgical gowns that fail to comply with those requirements during the COVID-19 public health emergency. To be exempt from those requirements under this Policy, the product must meet the consensus standard for rubber surgical gloves (ASTM D3577) and include appropriate labeling as described on pp. 11-12 of the Policy.