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 |