Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023812384

FEI Number

3023812384

Entity Name

HUZHOU UNIVERSAL GLOVE COMPANY LIMITED

City/State/Country

Huzhou Zhejiang, CN

Establishment Address

The frist floor of 2# Detection Workshop,Building 1,No. 333-2 South of Qufu Road,Balidian Town,Wuxing Distri, Huzhou Zhejiang 3130000, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Huzhou Universal Glove Company Limited (Owner Number: 10086062)

Owner / Operator Contact Address

The frist floor of 2# Detection Workshop,Building 1,No. 333-2 South of Qufu Road,Balidian Town,Wuxing Distri, Huzhou, CN-ZJ 3130000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Restraint, protective ORTHOSIS, THORACIC SUNGLASSES FILM,FFAME TAG,EYESHIELDS,OCCLUDER Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear) JOINT, SHOULDER, EXTERNAL LIMB COMPONENT MASK, SCAVENGING External urethral occluder, urinary incontinence-control, female Radiographic protective Glove UNIT, WRIST, EXTERNAL LIMB COMPONENT, MECHANICAL Joint, elbow, external limb component, mechanical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMQ	Restraint, Protective	General Hospital	Class 1	880.6760	2022-11-30
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2022-10-13
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-10-13
IQQ	Joint, Shoulder, External Limb Component	Physical Medicine	Class 1	890.3420	2022-11-30
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2022-10-13
MNG	External Urethral Occluder, Urinary Incontinence-Control, Female	Gastroenterology, Urology	Class 1	876.5160	2022-10-13
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2022-10-13
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2022-11-30
IRD	Joint, Elbow, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2022-11-30

Official Correspondent

da aman

US Agent Details

yun chen Business: HYUNTURLEE-COMMERCEINC Email: yun.chen@hyunturlee-commerce.com Phone: (626) 6783399

Related Public Records

Same Entity

Huzhou Universal Glove Company Limited

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K962327	Sekure Seat Corp.	SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE	1997-03-06
K963243	Heelbo, Inc.	HEELBO BLAZER SLEEVED JACKET	1996-10-01

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3027592416	VIPER EMERGENCY MEDICAL RESTRAINTS, LLC	Shrewsbury, MA, US
3015173212	Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023812384. Last updated year: 2026. Please use registration number 3023812384 when referencing this establishment in official correspondence.