The following data is part of a premarket notification filed by Vitalcare Group, Inc. with the FDA for Vinyl Powdered Exam Glove / Cat.# 15-020.
| Device ID | K992289 |
| 510k Number | K992289 |
| Device Name: | VINYL POWDERED EXAM GLOVE / CAT.# 15-020 |
| Classification | Vinyl Patient Examination Glove |
| Applicant | VITALCARE GROUP, INC. 15800 N.W. 13TH AVE. Miami, FL 33169 |
| Contact | Ginger Talley |
| Correspondent | Ginger Talley VITALCARE GROUP, INC. 15800 N.W. 13TH AVE. Miami, FL 33169 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-07 |
| Decision Date | 1999-08-04 |