Protech Proguard
Radiation Reducing Gloves
48manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (18), Guangdong (5), Hebei (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanxi Hongjin Plastic Technology Co., Ltd. | Linfen | Shanxi | Contract manufacturer | 5 |
| YUE Kang Anhui Medical Products Co., Ltd. | Huaibei | Anhui | Contract manufacturer | 5 |
| Opus Gloves Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Better Care Plastic Technology Co., Ltd. | Shenze County | Hebei | Contract manufacturer | 4 |
| Xingyu Medical Tech Co., Ltd. | Weifang | Shandong | Contract manufacturer | 4 |
| Lingshi Hongruida Health Protection Technology Co., Ltd. | Jinzhong | Shanxi | Contract manufacturer | 4 |
| Zhangjiagang Dayu Rubber Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 4 |
| Jiangxi Zhonghong Pulin Medical Products Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 3 |
| Zhongnuo Medical Products Co., Ltd. | Tangshan | Hebei | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
Showing 12 of 48. All 48 manufacturers in China registered for Medical Glove, Specialty
Record
| Listed by | Emerson & Co. Srl, Italy |
|---|---|
| FDA product code | LZC |
| Device type | Medical Glove, Specialty |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| Record published | 2018-03-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: in a dry place away from light and heat sources (below 35°) |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RR265 | In distribution | |
| RR165 | In distribution | |
| RR280 | In distribution | |
| RR160 | In distribution | |
| RR270 | In distribution | |
| RR180 | In distribution | |
| RR170 | In distribution | |
| RR190 | In distribution | |
| RR275 | In distribution | |
| RR260 | In distribution | |
| RR175 | In distribution | |
| RR185 | In distribution | |
| RR290 | In distribution | |
| RR285 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | O&M Halyard, Inc. | 119 |
| Europapa | Europapa Handels GmbH | 40 |
| Tronex International, Inc. | Tronex International, Inc. | 37 |
| PremierPro | Prestige Ameritech | 37 |
| Medicom AssureTouch | AMD Medicom Inc. | 29 |
| Ocean Pacific | AMD Medicom Inc. | 25 |
| MediChoice | Owens & Minor Distribution, Inc. | 24 |
| FreeStyle | Hourglass International Inc | 22 |
| Novaplus | Cardinal Health 200, LLC | 21 |
| Scion | Hourglass International Inc | 20 |
| Cardinal Health | Cardinal Health 200, LLC | 18 |
| Flexal | Cardinal Health 200, LLC | 18 |
Showing 12 of 174. All products under Medical Glove, Specialty
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K982832 | 1998-12-23 |
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.