Topmed
Catalogue number M4006, listed by Xiantao Topmed Nonwoven Protective Products Co., Ltd., China, under Suit, Surgical. 74 manufacturers in China are registered for this product code.
74manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Hubei (29), Jiangsu (13), Guangdong (8). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Fomed Industries Inc | Qian Jiang | Hubei | Contract manufacturer | 19 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Qingdao Likangyuan Medical Device Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 14 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
| Hubei Weikang Protective Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 12 |
| Crown Name Disposable Hygiene Products Fty. Ltd. | Wuhan | Hubei | Contract manufacturer | 11 |
| Anhui Ivymed Medical Products Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 10 |
| Jiangsu Hanfang Textile Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 8 |
| Xiantao Chenguang Protection Commodity Co Ltd | Xiantao | Hubei | Contract manufacturer | 7 |
Showing 12 of 74. All 74 manufacturers in China registered for Suit, Surgical
Record
| Listed by | Xiantao Topmed Nonwoven Protective Products Co., Ltd., China |
|---|---|
| FDA product code | FXO |
| Device type | Suit, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4040 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M4006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 10 |
| customized | Qingdao Bestex Rubber & Plastic Products Co., Ltd. | 10 |
| Surgyco | Surgyco LLC | 10 |
| Tronex International, Inc. | Tronex International, Inc. | 7 |
| Chongjen | Shanghai Chongjen Industry Co., Ltd. | 7 |
| Indaljimtm | Indaljim, S.A. de C.V. | 6 |
| Novaplus | Cardinal Health 200, LLC | 4 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 3 |
| Natural Extensions | Benco Dental Supply Co. | 2 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2 |
| TSW | Xiantao TSW Protective Products Co., Ltd. | 1 |
| Hepro.us Lab Suit 1 Pouch | Hepro.us Inc. | 1 |
Showing 12 of 18. All products under Suit, Surgical
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.