The following data is part of a premarket notification filed by Medical Products Search, Inc. with the FDA for Patient Examination Gloves.
Device ID | K905665 |
510k Number | K905665 |
Device Name: | PATIENT EXAMINATION GLOVES |
Classification | Latex Patient Examination Glove |
Applicant | MEDICAL PRODUCTS SEARCH, INC. 2596 REYNOLDA RD. SUITE D Winston-salem, NC 27106 |
Contact | Milton Bates |
Correspondent | Milton Bates MEDICAL PRODUCTS SEARCH, INC. 2596 REYNOLDA RD. SUITE D Winston-salem, NC 27106 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-12-18 |
Decision Date | 1991-01-15 |