Data / Medical devices / China / Xiantao Topmed Nonwoven Protective Products Co., Ltd
Xiantao Topmed Nonwoven Protective Products Co., Ltd: FDA-registered device maker in xiantao Hubei, China, 2 510(k) clearances
Xiantao Topmed Nonwoven Protective Products Co., Ltd is registered with the FDA (registration 3012268821) in xiantao Hubei, China. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 20, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012268821
- Address
- North of the National Road 318 Dongjiazui Village,Huchang Town, xiantao Hubei, China, 433000
- Owner or operator
- Xiantao Topmed Nonwoven Protective Products Co., Ltd (10081073)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- March 15, 2021
- Registered through
- 2026
- Brand names listed
- BED SHEET, BED COVER, BED SHEET ROLL,DENTAL SHEET, BOOT COVER, DISPOSABLE SLIPPER,SLEEVE COVER, SHOE COVER, CAP/DISPOSABLE CAP/NONWOVEN CAP/MOB CAP, CLIP CAP/ROUND CAP,NURSE CAP,BALACLAVE CAP, SURGICAL CAP, CPE GOWN,ISOLAITON GOWN, PE RAIN COAT, Dental bib, Diaper, Disposable Medical Face Mask (ear loop) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Absorber, Saliva, Paper | KHR | 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 | Manufacturer | accessdata.fda.gov |
| Cover, Shoe, Operating-Room | FXP | 1 | Manufacturer | accessdata.fda.gov |
| Garment, Protective, For Incontinence | EYQ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | 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 | Manufacturer | accessdata.fda.gov |
| Pad, Menstrual, Unscented | HHD | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | 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 |
|---|---|---|---|---|---|---|
| October 20, 2022 | K221977 | Disposable Surgical Gown (G4003) | FYA | Substantially Equivalent | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | accessdata.fda.gov |
| July 22, 2022 | K221196 | Disposable Medical Face Mask (ear loop) | FXX | Substantially Equivalent | Xiantao Topmed Nonwoven Protective Products Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Cover, Shoe, Operating-Room
- All makers of Gauze / Sponge,Nonresorbable For External Use
- All makers of Garment, Protective, For Incontinence
- All makers of Pad, Menstrual, Unscented
- All makers of Cap, Surgical
- All makers of Mask, Surgical
Updated October 20, 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.