April 2, 2020

FDA Updates Enforcement Discretion Policy For Gowns, Gloves, and Other Apparel

+ Follow Contact

Send

Embed

FDA took action earlier this week to relax regulatory standards for gowns, hoods, and surgeons’ and patient examination gloves during the pandemic. The policy applies to the following products:

Table 1

Classification Regulation	Device Type	Product Code⁶	Class
21 CFR 878.4040	Conductive Shoe and Shoe Cover	BWP	I (exempt)
21 CFR 878.4040	Operating-Room Shoes	FXW	I (exempt)
21 CFR 878.4040	Surgical Apparel Accessory	LYU	I (exempt)
21 CFR 878.4040	Non-surgical isolation gowns	OEA	I (exempt)
21 CFR 878.4040	Surgical suits	FXO	I (exempt)
21 CFR 878.4040	Operating-room shoe covers	FXP	I (exempt)
21 CFR 878.4040	Surgical helmets	FXZ	I (exempt)
21 CFR 878.4040	Surgical dress	FYE	I (exempt)
21 CFR 878.4040	Surgical caps	FYF	I (exempt)
21 CFR 878.4040	Surgical gown/toga	FYA	II
21 CFR 878.4040	Patient gown	FYB	II
21 CFR 878.4040	Surgical isolation gown	FYC	II
21 CFR 878.4040	Surgical hood	FXY	II

Table 2

Classification Regulation	Device Type	Product Code	Class
21 CFR 880.6250	Patient examination glove	FMC	I (reserved)
21 CFR 880.6250	Latex Patient Examination Glove	LYY	I (reserved)
21 CFR 880.6250	Polymer Patient Examination Glove	LZA	I (reserved)
21 CFR 880.6250	Finger Cot	LZB	I (exempt)
21 CFR 880.6250	Vinyl Patient Examination Glove	LYZ	I (reserved)
21 CFR 880.6250	Powder-Free Guayle Rubber Examination Glove	OIG	I (reserved)
21 CFR 880.6250	Powder-Free Polychloroprene Patient Examination Glove	OPC	I (reserved)
21 CFR 880.6250	Radiation Attenuating Medical Glove	OPH	I (reserved)
21 CFR 880.6250	Specialty Patient Examination Glove	LZC	I (reserved)
21 CFR 878.4460	Surgeon’s Gloves	KGO	I (reserved)
21 CFR 878.4460	Powder-Free Non-Natural Rubber Latex Surgeon’s Gloves	OPA	I (reserved)

As it has for face masks and respirators, FDA is exercising enforcement discretion with respect to non-surgical gowns, surgical gowns, patient exam gloves, and surgeon’s gloves. Provided that these items are marketed using labeling that expressly delineates the uses for which they are appropriate, warns against uses that may create excessive risk, meets applicable barrier protection/flammability/sterility standards, and does not indicate a use that may increase risk, FDA is relaxing standards for device registration and listing, premarket notification (where applicable), and quality system regulation compliance. The guidance includes specific labeling criteria for each of these items. The policy is effective immediately.

[View source.]

Send Print Report

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.