Consulting Wallah › Device Explorer › Gloves & PPE › Surgical/medical face mask, antimicrobial, single-
Device Explorer · FDA GUDID · GMDN 66197

Surgical/medical face mask, antimicrobial, single-use

A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate m

US‑registered devices76in commercial distribution
Companies11labelers on GUDID
Single‑use99%of device records
Sterile4%labelled sterile
Prescription0%Rx‑only share
ShareLinkedIn

Share of device records

Cardinal Health 200, Llc2229%
Copious International Inc.2026%
Copioumed International Inc.2026%
Henan Yadu Industry Co., Ltd.45%
Prestige Ameritech, Ltd.34%
Apothecary Products, Llc23%
Ammex-Weida (Hubei) Health And Safety Products Co., Ltd11%
Medisca Inc.11%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc2229%
Copious International Inc.2026%
Copioumed International Inc.2026%
Henan Yadu Industry Co., Ltd.45%
Prestige Ameritech, Ltd.34%
Apothecary Products, Llc23%
Ammex-Weida (Hubei) Health And Safety Products Co., Ltd11%
Medisca Inc.11%
Gd Care Inc.11%
Shenzhen Safesecure Medical Infection Control Tech Co., Ltd11%
Pm Excellence Llc Doo Beograd11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

WEIDA, JINLIANGYADUCopioumedProGear/OxafenceWalmartMedisca Safe-SenseCareFLENTSCONVERTORSCARDINAL HEALTHSafeSecurePM Excellence SEQUR 100

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
FXXMask, Surgical56
FXXMask, surgical22
OUKSurgical Mask With Antimicrobial/Antiviral Agent3

GMDN & GCC registration

  • GMDN code 66197 · non‑implantable
  • Single‑use 99% · sterile 4% · Rx‑only 0% · OTC 38%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many surgical/medical face mask, antimicrobial, single-use products are registered in the US?

76 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical/medical face mask, antimicrobial, single-use", from 11 companies. The largest labeler is Cardinal Health 200, Llc with 29% of records.

Which FDA product codes apply?

FXX (Mask, Surgical), FXX (Mask, surgical), OUK (Surgical Mask With Antimicrobial/Antiviral Agent)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

Add surgical/medical face mask, antimicrobial, single-use to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Surgical/medical face mask, antimicrobial, single-use

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying surgical/medical face mask, antimicrobial, single- for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

Get quotes →