The following data is part of a premarket notification filed by Ems Medical, Inc. with the FDA for Glove N Gel.
| Device ID | K896306 |
| 510k Number | K896306 |
| Device Name: | GLOVE N GEL |
| Classification | Latex Patient Examination Glove |
| Applicant | EMS MEDICAL, INC. 302 LINDBERGH AVE. Livermore, CA 94550 |
| Contact | Paul Ulbrich |
| Correspondent | Paul Ulbrich EMS MEDICAL, INC. 302 LINDBERGH AVE. Livermore, CA 94550 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-30 |
| Decision Date | 1989-12-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GLOVE N GEL 74108065 1698560 Dead/Cancelled |
EMS MEDICAL, INC. 1990-10-22 |