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Device Explorer · FDA GUDID · GMDN 35092

Patient gown, single-use

A non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeve

US‑registered devices172in commercial distribution
Companies16labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription31%Rx‑only share
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Share of device records

Encompass Group, L.L.C.5431%
A Plus International Inc.3722%
O&M Halyard, Inc.169%
Adroit Medical Systems, Inc.159%
Precept Medical Products, Inc.138%
Dynarex Corporation95%
Mckesson Medical-Surgical Inc.85%
National Distribution & Contracting, Inc.63%

Top labelers

CompanyDevicesShare
Encompass Group, L.L.C.5431%
A Plus International Inc.3722%
O&M Halyard, Inc.169%
Adroit Medical Systems, Inc.159%
Precept Medical Products, Inc.138%
Dynarex Corporation95%
Mckesson Medical-Surgical Inc.85%
National Distribution & Contracting, Inc.63%
Endure Industries32%
Cardinal Health 200, Llc21%
Young Innovations, Inc.21%
Medline Industries, Inc.21%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CDHTCopioumedCARDINAL HEALTHDefendENDURE INDUSTRIESA PlusExam Gown, 3 plyExam Capes, Tissue/Poly/Tissue 3-ply, Lavender, Exam Capes, Tissue/Poly/Tissue 3-ply, Mauve, UniExam Capes, Tissue/Poly/Tissue 3-ply, Blue, UnivExam Capes, Tissue/Poly/Tissue 3-ply, White, UniExam Gowns, Tissue/Poly/Tissue 3-ply, Lavender, Exam Gowns, Tissue/Poly/Tissue 3-ply, Mauve, UniExam Gowns, Tissue/Poly/Tissue 3-ply, Blue, UnivExam Gowns, Tissue/Poly/Tissue 3-ply, White, Uni

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

FDA product codes

CodeNameDevices
FMEGown, Examination106
LYUAccessory, Surgical Apparel51
FMEGown, examination8
OEANon-Surgical Isolation Gown6
OEANon-surgical isolation gown6
KMEBedding, Disposable, Medical4

GMDN & GCC registration

  • GMDN code 35092 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 31% · OTC 14%
  • 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 patient gown, single-use products are registered in the US?

172 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient gown, single-use", from 16 companies. The largest labeler is Encompass Group, L.L.C. with 31% of records.

Which FDA product codes apply?

FME (Gown, Examination), LYU (Accessory, Surgical Apparel), FME (Gown, examination), OEA (Non-Surgical Isolation Gown)

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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