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Sign in to claim this brandHangzhou Atek Medical & Textile Co., Ltd.
US
Last updated May 23, 2026
What Hangzhou Atek Medical & Textile Co., Ltd. makes
The company manufactures ATEK Surgical Gowns, a type of protective disposable gown designed for use in surgical and clinical environments to prevent contamination during medical procedures.
These gowns are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
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 Hangzhou Atek Medical & Textile Co., Ltd. manufacture?
Hangzhou Atek Medical & Textile Co., Ltd. specializes in manufacturing ATEK Surgical Gowns. These are disposable protective gowns designed specifically for surgical and clinical settings to help prevent contamination during medical procedures.
Where is Hangzhou Atek Medical & Textile Co., Ltd. based?
The company is based in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs the classification and listing of its devices.
How are ATEK Surgical Gowns classified under FDA regulations?
ATEK Surgical Gowns are classified as Class II devices under FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.
Which regulatory registries or databases list Hangzhou Atek Medical & Textile Co., Ltd.’s devices?
Hangzhou Atek Medical & Textile Co., Ltd.’s devices, including ATEK Surgical Gowns, are listed in the FDA’s 510(k) registry. This pathway is used for devices that are substantially equivalent to legally marketed predicates, ensuring compliance with FDA requirements before they enter the market.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Vacuum Collection Bottle | 28031 | FDA UDI | Class I | Active |
| Non-Surgical Isolation Gown | 28027 | FDA UDI | Class I | Active |
| Table Tray For Operating Room | 28028 | FDA UDI | Class I | Active |
| Operating-Room Shoe Cover | 28024 | FDA UDI | Class I | Active |
| Examination Gown | 28021 | FDA UDI | Class I | Active |
| Surgical Cap | 28022 | FDA UDI | Class I | Active |
| Disposable Hot Or Cold Pack Cover | 28030 | FDA UDI | Class I | Active |
| Disposable Bedding Products | 28020 | FDA UDI | Class I | Active |
| Resuable Incontinence Underpad | 28019 | FDA UDI | Class I | Active |
| Gas Collecting Vessel | 28032 | FDA UDI | Class I | Active |
| Surgical Apparel Accessory | 28023 | FDA UDI | Class I | Active |
| Surgical Gown | 28025 | FDA UDI | Class II | Active |
| Conductive Shoe And Shoe Cover | 28029 | FDA UDI | Class I | Active |
| Atek Surgical Gowns | K100971 | FDA 510(k) | Class II | Active |
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