The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Cypress Medical Products Vinyl Examination Glove.
Device ID | K952367 |
510k Number | K952367 |
Device Name: | CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE |
Classification | Latex Patient Examination Glove |
Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-11 |
Decision Date | 1995-07-05 |