The following data is part of a premarket notification filed by Wilson Glove Products Co., Ltd. with the FDA for Patient Examination Gloves (vinyl).
Device ID | K892587 |
510k Number | K892587 |
Device Name: | PATIENT EXAMINATION GLOVES (VINYL) |
Classification | Vinyl Patient Examination Glove |
Applicant | WILSON GLOVE PRODUCTS CO., LTD. 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
Contact | Alan P Schwartz |
Correspondent | Alan P Schwartz WILSON GLOVE PRODUCTS CO., LTD. 55 NORTHERN BLVD. SUITE 205 Great Neck, NY 11021 |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-11 |
Decision Date | 1989-07-14 |