Data / Medical devices / China / Qingdao Bestex Rubber & Plastic Products Co., Ltd
Qingdao Bestex Rubber & Plastic Products Co., Ltd: FDA-registered device maker in PINGDU, QINGDAO Shandong, China, 1 510(k) clearance
Qingdao Bestex Rubber & Plastic Products Co., Ltd is registered with the FDA (registration 9616862) in PINGDU, QINGDAO Shandong, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616862
- FEI number
- 3003208290
- Address
- 8-5 Guangzhou Road, PINGDU, QINGDAO Shandong, China, --
- Owner or operator
- QINGDAO BESTEX RUBBER & PLASTIC PRODUCTS CO., LTD (9042112)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 22, 2008
- Registered through
- 2026
- Brand names listed
- Surgical face mask
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 26, 2022 | K220597 | Disposable Surgical Face Mask (FM-34EE,FM-44EE) | FXX | Substantially Equivalent | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Surgical
- All makers of Respirator, Surgical
- All makers of Suit, Surgical
- All makers of Accessory, Surgical Apparel
Updated May 26, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.