The following data is part of a premarket notification filed by Arista Medi Prima with the FDA for Vinyl Patient Examination Gloves.
| Device ID | K964629 |
| 510k Number | K964629 |
| Device Name: | VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ARISTA MEDI PRIMA JL. K. H. MOH MANSYUR 128 Jakarta, ID 11210 |
| Contact | Hady Suyantho |
| Correspondent | Hady Suyantho ARISTA MEDI PRIMA JL. K. H. MOH MANSYUR 128 Jakarta, ID 11210 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-19 |
| Decision Date | 1997-02-10 |