Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616862

FEI Number

3003208290

Entity Name

QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD

City/State/Country

PINGDU, QINGDAO Shandong, CN

Establishment Address

8-5 Guangzhou Road, PINGDU, QINGDAO Shandong --, CN

Establishment Type(s)

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

Owner / Operator

QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD (Owner Number: 9042112)

Owner / Operator Contact Address

8-5 Guangzhou Road, --, PINGDU, QINGDAO, CN-NOTA --, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220597

PMA Number

N/A

All Registered Proprietary Names

Surgical face mask

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	2011-06-05
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-05-03
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-12-01

Official Correspondent

ZECHUAN SHAO

US Agent Details

Wendy Wang Email: wwa1666@gmail.com Phone: (408) 8913169

Related Public Records

Same Entity

QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
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

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 9616862. Last updated year: 2026. Please use registration number 9616862 when referencing this establishment in official correspondence.