Consulting Wallah › Device Explorer › Other devices › Face splash shield, reusable
Device Explorer · FDA GUDID · GMDN 64779

Face splash shield, reusable

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 reusable

US‑registered devices69in commercial distribution
Companies11labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription35%Rx‑only share
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Share of device records

Molded Products, Inc.3145%
Diadent Group International2435%
Cliktech Llc57%
Medsource International Llc23%
Shenzhen Med-Link Electronics Tech Co.,Ltd.11%
Paragon Medical, Inc.11%
Aakron Rule Corp.11%
Mazza Healthcare Llc11%

Top labelers

CompanyDevicesShare
Molded Products, Inc.3145%
Diadent Group International2435%
Cliktech Llc57%
Medsource International Llc23%
Shenzhen Med-Link Electronics Tech Co.,Ltd.11%
Paragon Medical, Inc.11%
Aakron Rule Corp.11%
Mazza Healthcare Llc11%
Strong Medical Partners Llc11%
Dealmed Medical Supplies Llc11%
Univet Srl11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MED-LINKIntubation ShieldSafco REPLACEMENT Face Shields-12 PackSafco PPE Face Shield System-6 PackClikRay Face Shield System-10 PackClikRay Face Shield Replacement Shields- 3 PackClikRay Face Shield SystemFace ShieldMHStrong ManufacturersMedSource Face ShieldDealmedMolded Products, Inc.DIA-400DTDIA-100PFSDIA-100SS

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 Apparel41
KPYShield, Protective, Personnel31
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea25
KGBMask, Oxygen, Non-Rebreathing2
LYUACCESSORY, SURGICAL APPAREL1

GMDN & GCC registration

  • GMDN code 64779 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 35% · OTC 10%
  • 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, reusable products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Face splash shield, reusable", from 11 companies. The largest labeler is Molded Products, Inc. with 45% of records.

Which FDA product codes apply?

LYU (Accessory, Surgical Apparel), KPY (Shield, Protective, Personnel), HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea), KGB (Mask, Oxygen, Non-Rebreathing)

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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