Xiantao Topmed Nonwoven Protective Products Co., Ltd.
Manufacturer and brand owner in Xiantao, Hubei, China. 11 device types, 11 products catalogued, 2 clearances.
Xiantao Topmed Nonwoven Protective Products Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cap, Surgical, Gown, Surgical and 9 other device types. 11 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
Registration
| Registered name | XIANTAO TOPMED NONWOVEN PROTECTIVE PRODUCTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3012268821 |
| FEI number | 3012268821 |
| DUNS | 547862097 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Xiantao |
|---|---|
| Province | Hubei |
| Address | North of the National Road 318 |
| Postal code | 433000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Absorber, Saliva, Paper | Class 1 | Dental bib | 2023 | 86 |
| Bedding, Disposable, Medical | Class 1 | Disposable pillow case, Disposable blanket | 2023 | 308 |
| Cap, Surgical | Class 1 | Clip CAP/Round Cap,nurse Cap,balaclave CAP, Surgical CAP, CAP/Disposable CAP/Nonwoven CAP/MOB CAP | 2021 | 178 |
| Cover, Shoe, Operating-Room | Class 1 | Boot Cover, Disposable Slipper,sleeve Cover, Shoe Cover | 2021 | 176 |
| Garment, Protective, For Incontinence | Class 1 | Diaper | 2023 | 181 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Nonwoven gauze | 2023 | 266 |
| Gown, Surgical | Class 2 | Disposable Surgical Gown (G4003) | 2022 | 68 |
| Mask, Surgical | Class 2 | Disposable Medical Face Mask (ear loop) | 2022 | 125 |
| Non-Surgical Gown | Class 1 | CPE Gown,isolaiton Gown, PE Rain Coat, Gown,apron,lab Coat, Patient Gown,scrub Suit | 2021 | 318 |
| Pad, Menstrual, Unscented | Class 1 | Underpad | 2023 | 132 |
| Suit, Surgical | Class 1 | BED Sheet, BED Cover, BED Sheet Roll,dental Sheet | 2021 | 74 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K221977 | 2022-10-20 | FYA | Traditional | This company |
| K221196 | 2022-07-22 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Surgical gowns, Surgical packs, Face masks, Protective clothing, Lab coats |
|---|---|
| Certifications | CE, CFDA, FDA, ISO 13485 |
| Export markets | Global (35+ language support) |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.