The following data is part of a premarket notification filed by Zhanjiang Jiali Glove Products Co., Ltd with the FDA for Medical Glove Series.
| Device ID | K072145 |
| 510k Number | K072145 |
| Device Name: | MEDICAL GLOVE SERIES |
| Classification | Latex Patient Examination Glove |
| Applicant | ZHANJIANG JIALI GLOVE PRODUCTS CO., LTD SUITE 8D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong ZHANJIANG JIALI GLOVE PRODUCTS CO., LTD SUITE 8D, NO. 19, LANE 999 ZHONGSHAN NO. 2 ROAD Shanghai, CN 200030 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-02 |
| Decision Date | 2008-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06947695010041 | K072145 | 000 |