The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Sterile Powder Free Synthetic Vinyl Patient Exam Glove.
| Device ID | K012282 |
| 510k Number | K012282 |
| Device Name: | STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Contact | Antonio L Giaccio |
| Correspondent | Antonio L Giaccio CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-20 |
| Decision Date | 2001-08-06 |