The following data is part of a premarket notification filed by Jiangsu Jaysun Glove Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K062522 |
| 510k Number | K062522 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | JIANGSU JAYSUN GLOVE CO., LTD. RM 1606 BLDG 1, JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD. Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan JIANGSU JAYSUN GLOVE CO., LTD. RM 1606 BLDG 1, JIANXIANG YUAN NO.209 BEI SI HUAN ZHONG RD. Beijing, CN 100083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-28 |
| Decision Date | 2006-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50096295133405 | K062522 | 000 |
| 50096295133399 | K062522 | 000 |
| 50096295133382 | K062522 | 000 |
| 50096295133375 | K062522 | 000 |