Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018299689

FEI Number

3018299689

Entity Name

GUILIN HBM HEALTH PROTECTIONS, INC.

City/State/Country

Guilin Guangxi, CN

Establishment Address

No.1-2, Shuijing East Road, Economic and Technological Development Area, Guilin Guangxi 541805, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guilin HBM Health Protections, Inc. (Owner Number: 10080538)

Owner / Operator Contact Address

No.1-2, Shuijing East Road, Economic and Technological Development Area, Guilin, CN-GX 541805, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDIZERO UNDERGLOVE SURGICAL GLOVES MEDIZERO LATEX SURGICAL GLOVE MEDIZERO POLYISOPRENE SURGICAL GLOVE RADIATION PROTECTION SURGICAL GLOVES

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2021-02-08
KGO	Surgeon'S Gloves	General, Plastic Surgery	Class 1	878.4460	2023-03-10
IWP	Radiographic Protective Glove	Radiology	Class 1	892.6500	2023-02-12

Official Correspondent

Shun Huang

US Agent Details

Da Shi Email: info@medicaldevice.org Phone: (949) 7678188

Related Public Records

Same Entity

Guilin HBM Health Protections, Inc.

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
K002933	Maxxim Medical	STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES	2000-10-19
K913402	Smith & Nephew Perry	PERRY(R) DERMAGUARD(R) PLUS GLOVES	1991-10-02

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3025413681	GUILIN HUADA BIOTECHNOLOGY CO., LTD.	Guilin City Guangxi, CN
8041005	WRP ASIA PACIFIC SDN. BHD.	SALAK TINGGI, SEPANG Selangor, MY
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018299689. Last updated year: 2026. Please use registration number 3018299689 when referencing this establishment in official correspondence.