Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008559312

FEI Number

3008559312

Entity Name

GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

#12, Guancun Road, Jiangpu Street,Conghua, Guangzhou Guangdong 510900, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GUANGZHOU FUZELONG HYGIENE MATERIAL CO.,LTD (Owner Number: 10033567)

Owner / Operator Contact Address

Intersection of Guancun Road, Jiangpu Street, Conghua, CN-GD 510970, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

puyuan IMPERTEC INDUSTRIES LTD Face Shield /Hood puyuan face shield surgical gown with hood Disposable Medical Mask PUYUAN Surgical Gown drap Medline Surgical Face Mask and Medline Procedural Face Mask Pu Yuan PUYUAN Surgical hood PUYUAN Emesis Basin PUYUAN PUYUAN peel away lens Protective Clothes (Protective Coveralls) Thumbhook gown level 2 surgical gown operation room gown coverall disposable shorts lab coat scrub suit apron scrub puyuan surgical packs puyuan SDKP-0406 Laparoscopic abdominal surgery drap 254*193*315cm

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2021-03-31
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-05-30
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2018-03-08
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-02-08
KGT	Drape, Adhesive, Aerosol	General, Plastic Surgery	Class 1	878.4380	2021-08-15
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2023-11-01
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2024-09-14
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-08-31
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2010-08-31
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2018-03-08
FME	Gown, Examination	General Hospital	Class 1	880.6265	2010-08-31
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2018-03-08
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-09-19
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2021-11-11
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2021-10-29

Official Correspondent

Yuehua Zhou

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

GUANGZHOU FUZELONG HYGIENE MATERIAL 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
K201622	Guangdong Kingfa Sci. & Tech.Co., Ltd.	Medical surgical mask	2020-11-24
K881618	3M Company	ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK	1988-05-09
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

Similar Registrations

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008559312. Last updated year: 2026. Please use registration number 3008559312 when referencing this establishment in official correspondence.