The following data is part of a premarket notification filed by Vitalcare Group, Inc. with the FDA for Latex Patient Examination Glove, Cat. No. 1000m Powdered.
| Device ID | K982901 |
| 510k Number | K982901 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-17 |
| Decision Date | 1998-12-21 |