Data / Medical devices / China / Xiamen Probtain Medical Technology Co.,ltd
Xiamen Probtain Medical Technology Co.,ltd: FDA-registered device maker in Xiamen Fujian, China, 5 510(k) clearances
Xiamen Probtain Medical Technology Co.,ltd is registered with the FDA (registration 3016680688) in Xiamen Fujian, China. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 7, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016680688
- Address
- No. 1 & No.3 Building, No.6, Ji'an Road, Tong'an District, Xiamen Fujian, China, 361100
- Owner or operator
- XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO.,LTD (10062942)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 13, 2020
- Registered through
- 2026
- Brand names listed
- Adult Nursing Pad, Baby Care Mat, Adult Diapers, Baby Diapers, Adult Insert Diapers, Bed Mattress, Bed Sheet, Caps, Disposable Isolation Gowns (S, M, L, XL, XXL, XXXL), Disposable Surgical Gowns (S, M, L, XL, XXL, XXXL), Disposable Surgical Mask, Face Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| 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 |
| Dress, Surgical | FYE | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Isolation, Surgical | FYC | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Scavenging | KHA | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 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 |
|---|---|---|---|---|---|---|
| March 7, 2023 | K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | FYA | Substantially Equivalent | Xiamen Probtain Medical Techology Co., Ltd. | accessdata.fda.gov |
| February 8, 2023 | K223304 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | FYC | Substantially Equivalent | Xiamen Probtain Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 4, 2023 | K223411 | Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) | FYC | Substantially Equivalent | Xiamen Probtain Medical Techology Co., Ltd. | accessdata.fda.gov |
| July 2, 2021 | K202954 | Disposable Surgical Mask | FXX | Substantially Equivalent | Xiamen Probtain Medical Techology Co., Ltd. | accessdata.fda.gov |
| December 9, 2020 | K201893 | Disposable Surgical Mask | FXX | Substantially Equivalent | Xiamen Probtain Medical Techology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Surgical Gown
- All makers of Fiber, Medical, Absorbent
- All makers of Gown, Isolation, Surgical
- All makers of Mask, Scavenging
- All makers of Garment, Protective, For Incontinence
- All makers of Gown, Surgical
Updated March 7, 2023. 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.