The following data is part of a premarket notification filed by Foodhandler, Inc. with the FDA for Patient Examination Gloves (latex).
Device ID | K892566 |
510k Number | K892566 |
Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
Classification | Latex Patient Examination Glove |
Applicant | FOODHANDLER, INC. 514 GRAND BLVD. Westbury, NY 11590 |
Contact | Sol Mendelsohn |
Correspondent | Sol Mendelsohn FOODHANDLER, INC. 514 GRAND BLVD. Westbury, NY 11590 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-10 |
Decision Date | 1989-06-23 |