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, Light Yellow Color.
| Device ID | K093570 |
| 510k Number | K093570 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR |
| 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 | 2009-11-18 |
| Decision Date | 2009-12-04 |
| Summary: | summary |