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Device Explorer · FDA GUDID · GMDN 61939

Surgical sleeve cover

A forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material b

US‑registered devices98in commercial distribution
Companies6labelers on GUDID
Single‑use13%of device records
Sterile1%labelled sterile
Prescription1%Rx‑only share
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Share of device records

Burlington Medical, Llc8486%
Alpha Pro Tech, Inc.99%
Medline Industries, Inc.22%
Leboo Healthcare Products Limited11%
Aspen Surgical Products, Inc.11%
Cardinal Health 200, Llc11%

Top labelers

CompanyDevicesShare
Burlington Medical, Llc8486%
Alpha Pro Tech, Inc.99%
Medline Industries, Inc.22%
Leboo Healthcare Products Limited11%
Aspen Surgical Products, Inc.11%
Cardinal Health 200, Llc11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LEBOOSymmetrySLEEVECONVERTORSMedlineCritical CoverCritica Cover

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

FDA product codes

CodeNameDevices
KPYShield, Protective, Personnel51
IWOApron, Protective33
LYUAccessory, Surgical Apparel12
GCJLaparoscope, General & Plastic Surgery2
LYUACCESSORY, SURGICAL APPAREL1
KKXDrape, surgical1

GMDN & GCC registration

  • GMDN code 61939 · non‑implantable
  • Single‑use 13% · sterile 1% · Rx‑only 1% · OTC 3%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 2

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

How many surgical sleeve cover products are registered in the US?

98 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical sleeve cover", from 6 companies. The largest labeler is Burlington Medical, Llc with 86% of records.

Which FDA product codes apply?

KPY (Shield, Protective, Personnel), IWO (Apron, Protective), LYU (Accessory, Surgical Apparel), GCJ (Laparoscope, General & Plastic Surgery)

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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