FDA Registration - Surgical Face Masks - FDA 510K Submission

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.