FDA Registration - Surgical Face Masks

Surgical face masks are regulated as Class II Medical devices with FDA device code FXX. Surgical face masks require FDA 510k clearance to market in the USA. After getting 510k clearance, the manufacturing establishment must register with FDA and list the surgical mask with FDA using the cleared 510k number.

Face masks: A mask, with or without a face shield, covers the user's nose and mouth and may or may not meet fluid barrier or filtration efficiency levels. Face masks should be used by the general public and health care personnel as source control in accordance with CDC.

Surgical masks: A mask intended for medical purposes that cover the user's nose and mouth and provides a physical barrier to fluids and particulate materials. Surgical masks are Class II medical devices. These masks meet certain fluid barrier protection standards and flammability requirements. Surgical masks are also tested for particulate and bacterial filtration efficiencies and biocompatibility and are considered personal protective equipment (PPE).

The FDA regulates face masks as medical devices when they are intended for medical purposes. Face masks marketed to the public for non-medical use, such as industrial and gardening activities, are not regulated by FDA.

FDA Classification for Medical Masks

Regulation Number

Product Code

Masks Type

868.5905

NMC

Mask, Ventilator, Non-Continuous, Reprocessed

868.5450

OBN

Humidifier, Respiratory, Mask

874.3400

KLW

Masker, Tinnitus

878.4040

FXX

Mask, Surgical

878.4040

OUK

Surgical Mask With Antimicrobial/Antiviral Agent

878.4040

OXZ

Pediatric/Child Facemask

868.5550

BSJ

Mask, Gas, Anesthetic

868.5560

BTK

Strap, Head, Gas Mask

868.5600

BYF

Mask, Oxygen, Low Concentration, Venturi

868.5580

BYG

Mask, Oxygen

868.5570

KGB

Mask, Oxygen, Non-Rebreathing

868.5590

KHA

Mask, Scavenging

--

QKR

Face Mask Per Enforcement Policy

--

QMF

Mask, Surgical, Eua Authorized

--

QOZ

Barrier Face Covering Per Enforcement Policy

--

RFG

Microelectronic Mask Or Chip Processing, Checking, And/Or Repair

LMG Assist surgical mask manufacturers in FDA registration, 510k clearance, device listing, and US FDA Agent requirements.

Our experienced consultants can help you to comply with FDA requirements. Our expertise includes

  • Prepare 510k notification
  • Submission of 510k notification
  • FDA Agent service for 510k submission
  • Guidance in test requirements
  • Register your medical device establishment with FDA
  • List your surgical mask with FDA.

Test requirements for Surgical Masks for US FDA 510K Submission

Biocompatibility tests required for Surgical Masks

Physical tests required for Surgical Masks

Contents of Surgical Masks 510k Notification

US FDA Medical Device Labeling Requirements - Surgical Masks

FDA 510K Clearance is public information; you can verify clearance status at the FDA site. Below are examples of surgical mask 510k clearance.