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 |