The following data is part of a premarket notification filed by Vitalcare Group, Inc. with the FDA for Vitalcare Powder Free Synthetic Vinyl Examination Glove.
| Device ID | K040916 |
| 510k Number | K040916 |
| Device Name: | VITALCARE POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | VITALCARE GROUP, INC. 8935 N.W. 27TH ST. Miami, FL 33172 |
| Contact | Michael Mcavenia |
| Correspondent | Michael Mcavenia VITALCARE GROUP, INC. 8935 N.W. 27TH ST. Miami, FL 33172 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-08 |
| Decision Date | 2005-05-04 |
| Summary: | summary |