Cap’n K
5 catalogue numbers from 09-MWSPN-XXL, listed by Elite Safety Products, under Patient Examination Glove. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Guangdong (2), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Hefei Jingcheng Plastic Products Co., Ltd. | Hefei | Anhui | Manufacturer | 24 |
| Shandong Ruyue Medical Technology Co., Ltd. | Binzhou | Shandong | Manufacturer | 14 |
| Zhangjiagang Shengang Medical Products Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Huizhou Anboson Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 3 |
| Dongguan Sengtor Plastics Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 3 |
Record
| Listed by | Elite Safety Products |
|---|---|
| FDA product code | FMC |
| Device type | Patient Examination Glove |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6250 |
| 510(k) | K110981 |
| Record published | 2022-07-31 |
| Record revised | 2022-10-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09-MWSPN-XXL | In distribution | |
| 09-MWSPN-S | In distribution | |
| 09-MWSPN-M | In distribution | |
| 09-MWSPN-L | In distribution | |
| 09-MWSPN-XL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Correct Touch | CT Intl. | 48 |
| Firm Touch | Elite Safety Products | 14 |
| Dental Mates | M.Y.T. USA Corp. | 5 |
| Alpha | Elite Safety Products | 5 |
| ruyue | Shandong Ruyue Medical Technology Co., Ltd. | 3 |
| Emergency Medical Products | Emergency Medical Products, Inc. | 1 |
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.