The following data is part of a premarket notification filed by Jiangsu Cureguard Glove Co., Ltd. with the FDA for Powder Free Vinyl Patinet Examination Gloves, Clear (non-colored).
| Device ID | K070076 |
| 510k Number | K070076 |
| Device Name: | POWDER FREE VINYL PATINET EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| 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 | 2007-01-08 |
| Decision Date | 2007-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20818634020066 | K070076 | 000 |
| 20818634020059 | K070076 | 000 |
| 20818634020042 | K070076 | 000 |
| 20818634020035 | K070076 | 000 |
| 20818634020028 | K070076 | 000 |