The following data is part of a premarket notification filed by Jiangsu Cureguard Glove Co., Ltd. with the FDA for Powdered Vinyl Patient Examination Gloves, (light Yellow).
| Device ID | K081657 |
| 510k Number | K081657 |
| Device Name: | POWDERED VINYL PATIENT EXAMINATION GLOVES, (LIGHT YELLOW) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | JIANGSU CUREGUARD GLOVE CO., LTD. ROOM 1606 BLDG. 1 JIANX. YUAN NO. 209 BEI SI HUAN ZHONG RD. Haidian District, Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan JIANGSU CUREGUARD GLOVE CO., LTD. ROOM 1606 BLDG. 1 JIANX. YUAN NO. 209 BEI SI HUAN ZHONG RD. Haidian District, 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 | 2008-06-12 |
| Decision Date | 2008-08-20 |
| Summary: | summary |