Consulting Wallah › Device Explorer › Gloves & PPE › Professional examination gown, single-use
Device Explorer · FDA GUDID · GMDN 32170

Professional examination gown, single-use

A garment made of natural and/or synthetic materials intended to be worn by healthcare providers, sometimes over scrub suits, while examining patients. It can be fluid resistant or impervious to fluid. An examination gown is used during patient examination pro

US‑registered devices753in commercial distribution
Companies37labelers on GUDID
Single‑use99%of device records
Sterile1%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Henry Schein, Inc.9613%
Amd Medicom Inc9513%
Cardinal Health 200, Llc9012%
Darby Dental Supply, Llc8011%
Resilient Medical Solutions, Llc7310%
Owens & Minor Distribution, Inc.557%
Tronex International, Inc.426%
Vivit Supply Llc365%

Top labelers

CompanyDevicesShare
Henry Schein, Inc.9613%
Amd Medicom Inc9513%
Cardinal Health 200, Llc9012%
Darby Dental Supply, Llc8011%
Resilient Medical Solutions, Llc7310%
Owens & Minor Distribution, Inc.557%
Tronex International, Inc.426%
Vivit Supply Llc365%
Changzhou Holymed Products Co.,Ltd.274%
Transparent Supply Solutions Ltd.243%
Cargus International, Inc172%
Essential Cares Supplies, Inc.142%

Company = labeler of record on GUDID. 37 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FlyteHOLYMEDEXAMINATION GOWNCopioumedDarby Dental Supply, LLCBritedentDealmedPlastcareStrong ManufacturersResilient Medical SolutionsEssential CaresPRABADINAMXOR Imperative 3-Layer SMS JacketAMXOR Imperative 3-Layers SMS JacketPrimaProMH

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

FDA product codes

CodeNameDevices
OEANon-surgical isolation gown288
LYUAccessory, Surgical Apparel199
LYUACCESSORY, SURGICAL APPAREL197
FMEGown, Examination75
OEANon-Surgical Gown39
OEANon-Surgical Isolation Gown34

GMDN & GCC registration

  • GMDN code 32170 · non‑implantable
  • Single‑use 99% · sterile 1% · Rx‑only 1% · OTC 52%
  • 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 professional examination gown, single-use products are registered in the US?

753 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Professional examination gown, single-use", from 37 companies. The largest labeler is Henry Schein, Inc. with 13% of records.

Which FDA product codes apply?

OEA (Non-surgical isolation gown), LYU (Accessory, Surgical Apparel), LYU (ACCESSORY, SURGICAL APPAREL), FME (Gown, Examination)

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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