The following data is part of a premarket notification filed by Arista Medi Prima with the FDA for Latex Examination Gloves, Powder Free.
| Device ID | K970977 |
| 510k Number | K970977 |
| Device Name: | LATEX EXAMINATION GLOVES, POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | ARISTA MEDI PRIMA 128 JALAN KYAI HAJI MUHAMMAD MANSYUR Jakarta Barat, ID 11210 |
| Contact | Hady Suyantho |
| Correspondent | Hady Suyantho ARISTA MEDI PRIMA 128 JALAN KYAI HAJI MUHAMMAD MANSYUR Jakarta Barat, ID 11210 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-14 |
| Decision Date | 1997-06-27 |