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Device Explorer · FDA GUDID · GMDN 66199

Surgical/medical face mask, non-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 devices968in commercial distribution
Companies105labelers on GUDID
Single‑use99%of device records
Sterile2%labelled sterile
Prescription4%Rx‑only share
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Share of device records

Amd Medicom Inc14115%
Primed Medical Products Inc12513%
O&M Halyard, Inc.919%
Vivit Supply Llc374%
Euronda Spa313%
Aok Tooling Limited283%
Premium Plus (Dongguan) Limited263%
Jiang Xi Sanxin Medtec Co., Ltd.242%

Top labelers

CompanyDevicesShare
Amd Medicom Inc14115%
Primed Medical Products Inc12513%
O&M Halyard, Inc.919%
Vivit Supply Llc374%
Euronda Spa313%
Aok Tooling Limited283%
Premium Plus (Dongguan) Limited263%
Jiang Xi Sanxin Medtec Co., Ltd.242%
Jmu Dental, Inc202%
Asp Global, Llc192%
Alpha Pro Tech, Inc.192%
Ismile Dental Products, Inc.182%

Company = labeler of record on GUDID. 105 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PRECISION ECO™ Plant Based Procedural Mask with PRECISION ECO™ Compostable Procedural Mask with Mölnlycke®TopmedDISPOSABLE FACE MASKS&JAllstarMDHCLEBOOFitgrowLyttopXIAN WANLIMakrite Industries Inc.LuesayUnifreeSanda

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

FDA product codes

CodeNameDevices
FXXMask, Surgical669
FXXMask, surgical360
LYUAccessory, Surgical Apparel42
OXZPediatric/Child Facemask21
KHAMask, Scavenging12
MSHRespirator, Surgical4

GMDN & GCC registration

  • GMDN code 66199 · non‑implantable
  • Single‑use 99% · sterile 2% · Rx‑only 4% · OTC 26%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 2Length (Inch) · 2

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

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

968 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical/medical face mask, non-antimicrobial, single-use", from 105 companies. The largest labeler is Amd Medicom Inc with 15% of records.

Which FDA product codes apply?

FXX (Mask, Surgical), FXX (Mask, surgical), LYU (Accessory, Surgical Apparel), OXZ (Pediatric/Child Facemask)

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.

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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.

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