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Device Explorer · FDA GUDID · GMDN 32297

Surgical cap, single-use

A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering i

US‑registered devices328in commercial distribution
Companies60labelers on GUDID
Single‑use100%of device records
Sterile1%labelled sterile
Prescription2%Rx‑only share
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Share of device records

A Plus International Inc.237%
Medline Industries, Inc.237%
Prestige Ameritech, Ltd.175%
O&M Halyard, Inc.175%
Mölnlycke Health Care Ab165%
Precept Medical Products, Inc.165%
Cardinal Health 200, Llc155%
Omnia Srl134%

Top labelers

CompanyDevicesShare
A Plus International Inc.237%
Medline Industries, Inc.237%
Prestige Ameritech, Ltd.175%
O&M Halyard, Inc.175%
Mölnlycke Health Care Ab165%
Precept Medical Products, Inc.165%
Cardinal Health 200, Llc155%
Omnia Srl134%
Copioumed International Inc.124%
Vivit Supply Llc124%
Dukal Llc113%
Emergency Medical Solutions Llc113%

Company = labeler of record on GUDID. 60 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INDALJIMTMMölnlycke®GOBENTopmedChongjenLEBOORTMEDSURGICAL CAPBIEDQCopioumedHYGITECHForsurePROOFPremierProStrong ManufacturersGD

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

FDA product codes

CodeNameDevices
FYFCap, Surgical191
FYFCAP, SURGICAL127
LYUAccessory, Surgical Apparel33
NRDUnit, Operative Dental, Accessories3
PXGSpill Kit1
OFFCentral venous catheter tray1

GMDN & GCC registration

  • GMDN code 32297 · non‑implantable
  • Single‑use 100% · sterile 1% · Rx‑only 2% · OTC 24%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 2

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

How many surgical cap, single-use products are registered in the US?

328 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical cap, single-use", from 60 companies. The largest labeler is A Plus International Inc. with 7% of records.

Which FDA product codes apply?

FYF (Cap, Surgical), FYF (CAP, SURGICAL), LYU (Accessory, Surgical Apparel), NRD (Unit, Operative Dental, Accessories)

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.

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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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