The following data is part of a premarket notification filed by Fujian Province Jiu Zhou Group with the FDA for Pvc Patient Examination Glove.
| Device ID | K902278 |
| 510k Number | K902278 |
| Device Name: | PVC PATIENT EXAMINATION GLOVE |
| Classification | Patient Examination Glove |
| Applicant | FUJIAN PROVINCE JIU ZHOU GROUP 2354 N.E. 94TH Seattle, WA 98115 |
| Contact | Lisa Zhang |
| Correspondent | Lisa Zhang FUJIAN PROVINCE JIU ZHOU GROUP 2354 N.E. 94TH Seattle, WA 98115 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-22 |
| Decision Date | 1990-08-29 |