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Device Explorer · FDA GUDID · GMDN 58376

Eye splash shield, single-use

A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or

US‑registered devices145in commercial distribution
Companies27labelers on GUDID
Single‑use81%of device records
Sterile6%labelled sterile
Prescription30%Rx‑only share
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Share of device records

Deroyal Industries, Inc.2618%
Tidi Products, Llc1510%
American Hospital Supply Llc1410%
Alpha Pro Tech, Inc.1410%
Wuxi Emsrun Technology Co., Ltd.107%
Owens & Minor Distribution, Inc.86%
Mckesson Medical-Surgical Inc.75%
Dupaco, Inc.64%

Top labelers

CompanyDevicesShare
Deroyal Industries, Inc.2618%
Tidi Products, Llc1510%
American Hospital Supply Llc1410%
Alpha Pro Tech, Inc.1410%
Wuxi Emsrun Technology Co., Ltd.107%
Owens & Minor Distribution, Inc.86%
Mckesson Medical-Surgical Inc.75%
Dupaco, Inc.64%
Prestige Ameritech, Ltd.53%
Premium Plus International Limited43%
Asp Global, Llc43%
Premium Plus (Dongguan) Limited43%

Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mölnlycke®RHINO RESCUEEMSRUNREFINEPU YUANUltraTectPremium PlusPlasdentProGearAmerican Hospital SupplyAMGASP MEDICALTIGER MEDICAL FULL FACE SHIELDTIGER MEDICAL LENS EYESHIELD DISPOSABLEPremierProCritical Cover

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 Apparel51
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea35
LYUACCESSORY, SURGICAL APPAREL30
HOYShield, eye, ophthalmic (including sunlamp protective eyewea20
FXXMask, Surgical14
HMPPad, Eye6

GMDN & GCC registration

  • GMDN code 58376 · non‑implantable
  • Single‑use 81% · sterile 6% · Rx‑only 30% · OTC 21%
  • 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 eye splash shield, single-use products are registered in the US?

145 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Eye splash shield, single-use", from 27 companies. The largest labeler is Deroyal Industries, Inc. with 18% of records.

Which FDA product codes apply?

LYU (Accessory, Surgical Apparel), HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea), LYU (ACCESSORY, SURGICAL APPAREL), HOY (Shield, eye, ophthalmic (including sunlamp protective eyewea)

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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