The following data is part of a premarket notification filed by Jiangsu Cureguard Glove Co., Ltd. with the FDA for Rubber-like Powder Free Vinyl Patient Examination Gloves, White Color.
| Device ID | K093576 |
| 510k Number | K093576 |
| Device Name: | RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR |
| 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 | 2009-11-18 |
| Decision Date | 2010-03-04 |
| Summary: | summary |