Consulting Wallah › Device Explorer › Gloves & PPE › Surgical/medical face mask, single-use
Device Explorer · FDA GUDID · GMDN 35177

Surgical/medical face mask, 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 devices876in commercial distribution
Companies114labelers on GUDID
Single‑use99%of device records
Sterile1%labelled sterile
Prescription4%Rx‑only share
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Share of device records

Precept Medical Products, Inc.799%
Henry Schein, Inc.708%
Prestige Ameritech, Ltd.627%
Maxill, Inc.526%
Young Mydent, Llc435%
Medline Industries, Inc.303%
Premium Plus International Limited303%
Darby Dental Supply, Llc233%

Top labelers

CompanyDevicesShare
Precept Medical Products, Inc.799%
Henry Schein, Inc.708%
Prestige Ameritech, Ltd.627%
Maxill, Inc.526%
Young Mydent, Llc435%
Medline Industries, Inc.303%
Premium Plus International Limited303%
Darby Dental Supply, Llc233%
3M Company233%
Owens & Minor Distribution, Inc.212%
Mölnlycke Health Care Ab182%
Cargus International, Inc182%

Company = labeler of record on GUDID. 114 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BarrierS&JAOSHANGFace Mask with shield earloopFace Mask tie onFace Mask earloopFace Mask with shield tie onShingShunSunsmedCCWZhiboKINGFAGREEN CROSSNAMEOSupple

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

FDA product codes

CodeNameDevices
FXXMask, Surgical513
FXXMask, surgical232
MSHRespirator,Surgical59
LYUAccessory, Surgical Apparel46
MSHRespirator, Surgical14
KHRAbsorber, Saliva, Paper11

GMDN & GCC registration

  • GMDN code 35177 · non‑implantable
  • Single‑use 99% · sterile 1% · Rx‑only 4% · OTC 51%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 2Width (Centimeter) · 2Length (Millimeter) · 1Width (Millimeter) · 1Length (Inch) · 1Width (Inch) · 1

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

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

876 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical/medical face mask, single-use", from 114 companies. The largest labeler is Precept Medical Products, Inc. with 9% of records.

Which FDA product codes apply?

FXX (Mask, Surgical), FXX (Mask, surgical), MSH (Respirator,Surgical), LYU (Accessory, Surgical Apparel)

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?

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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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