The following data is part of a premarket notification filed by Foodhandler, Inc. with the FDA for Vinyl Patient Examination Gloves.
Device ID | K892575 |
510k Number | K892575 |
Device Name: | VINYL PATIENT EXAMINATION GLOVES |
Classification | Vinyl 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 | LYZ |
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 | 1989-07-24 |