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.

*                      *                      *

For other helpful information during this pandemic, visit our COVID-19 Resource Center and our Advertising and Privacy Law Resource Center.