Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025413681

FEI Number

3025413681

Entity Name

GUILIN HUADA BIOTECHNOLOGY CO., LTD.

City/State/Country

Guilin City Guangxi, CN

Establishment Address

Block B-12, Suqiao industrial Park, Suqiao Town, Yongfu County,, Guilin City Guangxi 541805, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Guilin Huada Biotechnology Co., Ltd. (Owner Number: 10086413)

Owner / Operator Contact Address

Block B-12, Suqiao industrial Park, Suqiao Town, Yongfu County,, Guilin City, CN-GX 541805, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

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	2022-11-08

Official Correspondent

Xiaonan Ye

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

Guilin Huada Biotechnology Co., Ltd.

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025413681. Last updated year: 2026. Please use registration number 3025413681 when referencing this establishment in official correspondence.