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Sign in to claim this brandQingdao Bestex Rubber & Plastic Products Co., Ltd.
US
Last updated May 25, 2026
What Qingdao Bestex Rubber & Plastic Products Co., Ltd. makes
The company manufactures single-use isolation gowns and face splash shields, including scented and customized versions for medical and protective use.
These products are regulated as Class I and Class II devices under FDA pathways, including 510(k) clearance and UDI listing.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Qingdao Bestex Rubber & Plastic Products Co., Ltd. manufacture?
Qingdao Bestex manufactures single-use isolation gowns and face splash shields. These products are designed for medical and protective use, with some variations including scented options like peppermint and customized designs. The company focuses on disposable protective gear, which is essential in healthcare settings to reduce contamination risk.
Where is Qingdao Bestex Rubber & Plastic Products Co., Ltd. based?
The company is based in the United States. While the name suggests a Qingdao origin, the manufacturing operations and regulatory filings are conducted through its US entity, which aligns with FDA compliance requirements for medical devices sold in the US market.
Which regulatory registries or databases list Qingdao Bestex’s medical devices?
Qingdao Bestex’s devices are listed in the FDA’s 510(k) clearance database and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US medical device regulations, allowing healthcare providers and regulators to verify product details and approval pathways.
How are Qingdao Bestex’s devices classified under FDA regulations?
The company’s products are classified as either Class I or Class II devices under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) clearance for Class II devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 530328087
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Peppermint Scented | K031157 | FDA 510(k) | Class I | Active |
| customized | L | FDA UDI | Class I | Active |
| customized | M | FDA UDI | Class I | Active |
| Bestex | FS-3222 | FDA UDI | Class I | Active |
| customized | M | FDA UDI | Class I | Active |
| customized | S | FDA UDI | Class I | Active |
| customized | XL | FDA UDI | Class I | Active |
| customized | XXL | FDA UDI | Class I | Active |
| customized | XL | FDA UDI | Class I | Active |
| customized | FS-3219 | FDA UDI | Class I | Active |
| customized | FS-3224 | FDA UDI | Class I | Active |
| customized | S | FDA UDI | Class I | Active |
| customized | FS-3219 | FDA UDI | Class I | Active |
| Bestex | FS-3222 | FDA UDI | Class I | Active |
| customized | L | FDA UDI | Class I | Active |
| customized | FS-3224 | FDA UDI | Class I | Active |
| customized | FS-3222 | FDA UDI | Class I | Active |
| customized | XXL | FDA UDI | Class I | Active |
| customized | FS-3222 | FDA UDI | Class I | Active |
| Powder-Free Latex Examination Glove (green) With Natural Water Soluble Vitamin E And Protein Content Labeling (50 Micro | K022566 | FDA 510(k) | Class I | Active |
| Disposable Surgical Face Mask (FM-34EE, FM-44EE) | K220597 | EUDAMEDFDA 510(k) | Class II | Active |
| Bestex Powder-Free Latex Exam Gloves With Labeling Claim. (50 Micrograms Or Less) | K002087 | FDA 510(k) | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Qingdao Bestex Rubber & Plastic Products Co., Ltd PINGDU, QINGDAO Shandong · CN FEI 3003208290