The following data is part of a premarket notification filed by Arista Medi Prima with the FDA for Latex Examination Gloves, Powdered.
| Device ID | K963742 |
| 510k Number | K963742 |
| Device Name: | LATEX EXAMINATION GLOVES, POWDERED |
| Classification | Latex Patient Examination Glove |
| Applicant | ARISTA MEDI PRIMA 769 MORNINGSIDE DR. Millbrae, CA 94030 |
| Contact | Chairina Breder |
| Correspondent | Chairina Breder ARISTA MEDI PRIMA 769 MORNINGSIDE DR. Millbrae, CA 94030 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-17 |
| Decision Date | 1996-11-20 |