Consulting Wallah › Device Explorer › Gloves & PPE › Isolation gown, reusable
Device Explorer · FDA GUDID · GMDN 35452

Isolation gown, reusable

A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carri

US‑registered devices171in commercial distribution
Companies10labelers on GUDID
Single‑use19%of device records
Sterile0%labelled sterile
Prescription24%Rx‑only share
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Share of device records

Standard Textile Co., Inc.4929%
Medline Industries, Inc.3923%
Novo Health Services, Llc3722%
Henry Schein, Inc.2414%
Bound Tree Medical, Llc64%
Maxill, Inc.53%
Lac-Mac Limited53%
Sri Healthcare, Llc42%

Top labelers

CompanyDevicesShare
Standard Textile Co., Inc.4929%
Medline Industries, Inc.3923%
Novo Health Services, Llc3722%
Henry Schein, Inc.2414%
Bound Tree Medical, Llc64%
Maxill, Inc.53%
Lac-Mac Limited53%
Sri Healthcare, Llc42%
Asp Global, Llc11%
Applied Dental, Inc.11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AQUIST WASHABLE ISOLATION GOWNASP MEDICALSUPERFITNOVO Health Services, LLCCuraplexSRI HealthcareReversible Isolation GownComPel Isolation GownReusable GownIsolation GownComPel Isolation Gown, EasyReleaseIsolation Gown EasyReleaseGeneric Polyester Isolation GownComPel Precaution GownPrecaution GownPrecaution/Isolation Gown

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 Gown127
FYAGown, Surgical73
OEANon-surgical gown40
FYCGown, Isolation, Surgical12
OEANon-Surgical Gown12
FYCGown, isolation, surgical12

GMDN & GCC registration

  • GMDN code 35452 · non‑implantable
  • Single‑use 19% · sterile 0% · Rx‑only 24% · OTC 46%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Height (Inch) · 59Weight (Pound) · 54Width (Inch) · 54

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

How many isolation gown, reusable products are registered in the US?

171 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Isolation gown, reusable", from 10 companies. The largest labeler is Standard Textile Co., Inc. with 29% of records.

Which FDA product codes apply?

OEA (Non-Surgical Isolation Gown), FYA (Gown, Surgical), OEA (Non-surgical gown), FYC (Gown, Isolation, Surgical)

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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