Consulting Wallah › Device Explorer › Gloves & PPE › Patient gown, reusable
Device Explorer · FDA GUDID · GMDN 11905

Patient gown, reusable

A garment made of natural and/or synthetic materials (e.g., 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-sleeved and is closed by

US‑registered devices94in commercial distribution
Companies5labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription43%Rx‑only share
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Share of device records

Standard Textile Co., Inc.4649%
Encompass Group, L.L.C.3840%
D-M-S Holdings, Inc.55%
Patientstyle Medical Llc33%
Novo Health Services, Llc22%

Top labelers

CompanyDevicesShare
Standard Textile Co., Inc.4649%
Encompass Group, L.L.C.3840%
D-M-S Holdings, Inc.55%
Patientstyle Medical Llc33%
Novo Health Services, Llc22%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PatientstylePatienstyleNOVO Health Services, LLCX-Ray GownMammogram CapeMAMMOGRAM CAPEMAMMOGRAPHY ROBEPATIENT GOWNMAMMOGRAM ROBEPoncho, ExaminationMAMMOGRAM JACKETX-RAY GOWNEXAM ROBEMAMOGRAM CAPEEncompassDMI

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

FDA product codes

CodeNameDevices
FMEGown, Examination178
OEANon-Surgical Isolation Gown6
FMWCover, Mattress (Medical Purposes)2

GMDN & GCC registration

  • GMDN code 11905 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 43% · OTC 49%
  • 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, reusable products are registered in the US?

94 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient gown, reusable", from 5 companies. The largest labeler is Standard Textile Co., Inc. with 49% of records.

Which FDA product codes apply?

FME (Gown, Examination), OEA (Non-Surgical Isolation Gown), FMW (Cover, Mattress (Medical Purposes))

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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