Consulting Wallah › Device Explorer › Other devices › Face splash shield, single-use
Device Explorer · FDA GUDID · GMDN 11961

Face splash shield, single-use

A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-us

US‑registered devices188in commercial distribution
Companies52labelers on GUDID
Single‑use98%of device records
Sterile3%labelled sterile
Prescription29%Rx‑only share
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Share of device records

Southmedic Incorporated2413%
Berkley Medical Resources, Inc.1910%
Stryker Corporation95%
Deroyal Industries, Inc.95%
O-Two Medical Technologies Inc84%
Qingdao Bestex Rubber & Plastic Products Co., Ltd.84%
Prestige Ameritech, Ltd.84%
Henry Schein, Inc.84%

Top labelers

CompanyDevicesShare
Southmedic Incorporated2413%
Berkley Medical Resources, Inc.1910%
Stryker Corporation95%
Deroyal Industries, Inc.95%
O-Two Medical Technologies Inc84%
Qingdao Bestex Rubber & Plastic Products Co., Ltd.84%
Prestige Ameritech, Ltd.84%
Henry Schein, Inc.84%
Batrik Medical Manufacturing Inc63%
Cardinal Health 200, Llc63%
Hygitech53%
Palmero Healthcare Llc53%

Company = labeler of record on GUDID. 52 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NASteriShieldCPR Bio-Barrier Training FaceshieldRescue Breather CPR Protective BarrierRescue Breather CPR Protective barrierRescue BreatherExact Medical Manufacturing, Inc.MDHCRTMEDFaced ShieldMedical Face ShieldGongdongSunmed Protective face shieldMED-LINKcustomizedBestex

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

FDA product codes

CodeNameDevices
LYUAccessory, Surgical Apparel59
LYUACCESSORY, SURGICAL APPAREL38
HOYShield, eye, ophthalmic (including sunlamp protective eyewea32
FXXMask, Surgical25
FXXMask, surgical11
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea10

GMDN & GCC registration

  • GMDN code 11961 · non‑implantable
  • Single‑use 98% · sterile 3% · Rx‑only 29% · OTC 15%
  • 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 face splash shield, single-use products are registered in the US?

188 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Face splash shield, single-use", from 52 companies. The largest labeler is Southmedic Incorporated with 13% of records.

Which FDA product codes apply?

LYU (Accessory, Surgical Apparel), LYU (ACCESSORY, SURGICAL APPAREL), HOY (Shield, eye, ophthalmic (including sunlamp protective eyewea), FXX (Mask, 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.

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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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