Qingdao Bestex Rubber & Plastic Products Co., Ltd.

Manufacturer and brand owner in Pingdu, Qingdao, Shandong, China. 4 device types, 3 products catalogued, 6 clearances.

Registry build 21.09.26

Qingdao Bestex Rubber & Plastic Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Suit, Surgical and 2 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2008.

4device types registered with the FDA
3products catalogued under its own name
6510(k) clearances

Registration

FDA registration record for Qingdao Bestex Rubber & Plastic Products Co., Ltd.
Registered name QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD
Status Registered
Registration expires 2026
Registration number 9616862
FEI number 3003208290
DUNS 530328087
Establishment type Contract manufacturer, Manufacturer, Exporter

Location

Address of Qingdao Bestex Rubber & Plastic Products Co., Ltd.
City Pingdu, Qingdao
Province Shandong
Address 8-5 Guangzhou Road
Postal code —
Country China

What It Makes

Device types Qingdao Bestex Rubber & Plastic Products Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Accessory, Surgical Apparel Class 1 2011 439
Mask, Surgical Class 2 Surgical face mask 2013 125
Respirator, Surgical Class 2 2020 118
Suit, Surgical Class 1 2008 74

Own-Brand Listings

Devices catalogued by Qingdao Bestex Rubber & Plastic Products Co., Ltd.
Product Code Catalogue numbers
customized FXO 10
customized LYU 6
Bestex LYU 2

Clearances

510(k) clearances naming Qingdao Bestex Rubber & Plastic Products Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K220597 2022-05-26 FXX Traditional This company
K042645 2004-11-26 LYY Traditional This company
K031157 2003-08-15 LZA Traditional This company
K022566 2002-10-15 LYY Traditional This company
K012709 2001-10-01 LYY Traditional This company
K002087 2000-09-13 LYY Traditional This company

From the Company

Published by the company on its own website, not by the FDA.

Information published by Qingdao Bestex Rubber & Plastic Products Co., Ltd.
Founded 1999
Employees 400
Factory area 10000 square meters
Main products Disposable face masks, Face shields, Lab coats, Isolation gowns, Examination gloves
Certifications ISO13485, CE certification (EU), FDA registration (USA)
Export markets Europe, North America, Latin America, Southeast Asia

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer