Defender Safety Surgical Mask Level 3

FDA UDI

Class II (US FDA UDI)

by Defender Safety, Inc.

Identity

Trade Name: Defender Safety Surgical Mask Level 3 FDA UDI
Generic Name: Surgical/medical face mask, single-use FDA UDI
Device Name: The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile. FDA UDI
Model / Reference: DSM-SM03-B FDA UDI
Description: The Defender Safety Procedure and Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single-use, disposable device, provided non-sterile. FDA UDI

Identifiers

Catalog Number: DSM-SM03-B FDA UDI
Primary DI / UDI-DI: 00860007209536 FDA UDI
510(k) Number: K210705 FDA UDI
FDA Product Code: FXX FDA UDI
GMDN Term: Surgical/medical face mask, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical/medical face mask, single-use

Defender Safety Surgical Mask Level 3 by Defender Safety, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical/medical face mask, single-use.

ProGear — Prestige Ameritech · Class II
Precept® — Precept Medical Products, Inc. · Class II
hcs — DYAD MEDICAL SOURCING, LLC · Class I
Precept® — Precept Medical Products, Inc. · Class II
AOSHANG — Tianjin Aoshang Outdoor Equipment Co., Ltd. · Class II
Precept® — Precept Medical Products, Inc. · Class II
Precept® — Precept Medical Products, Inc. · Class II
Surgical Face Mask — Foshan Nanhai Plus Medical Co., Ltd · Class II

Cleared under the same submission

K210705 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Defender Safety, Inc.

Sources (1)

FDA UDI 3f8bd562-7578-4d3f-8200-ca3feda5d2f7 36 fields · synced May 30, 2026