Data / Medical devices / Vietnam / Sanmu (vietnam) Protective Products Co., Ltd
Sanmu (vietnam) Protective Products Co., Ltd: FDA-registered device maker in Duc Hoa Commune Tay Ninh, Vietnam, 1 510(k) clearance
Sanmu (vietnam) Protective Products Co., Ltd is registered with the FDA (registration 3019848304) in Duc Hoa Commune Tay Ninh, Vietnam. It lists 11 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 29, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019848304
- Address
- Lot C1, Road No. 8, Hai Son Industrial Park (Phase 3&4), Binh Tien 2 Hamlet, Duc Hoa Commune Tay Ninh, Vietnam, 82700
- Owner or operator
- SANMU (VIETNAM) PROTECTIVE PRODUCTS CO., LTD (10082398)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- July 22, 2021
- Registered through
- 2026
- Brand names listed
- CSR Wrap, Coverall, Disposable Medical Bedding, Doctor cap, Exam table paper, Gemini Sterilization Wrap, Isolation gown, Protective coverall, Patient examination gown and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Accessory, Surgical Apparel | LYU | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Bedding, Disposable, Medical | KME | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cap, Surgical | FYF | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Examination | FME | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Wrap, Sterilization | FRG | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| March 29, 2021 | K202191 | Surgical Mask | FXX | Substantially Equivalent | Wuhan Zonsen Medical Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Wrap, Sterilization
- All makers of Mask, Surgical
- All makers of Drape, Surgical, Exempt
- All makers of Gown, Examination
- All makers of Non-Surgical Gown
- All makers of Absorber, Saliva, Paper
Updated March 29, 2021. 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.