The following data is part of a premarket notification filed by Pt. Trihasta Loka Persada with the FDA for Revised Patient Examination Gloves.
| Device ID | K896411 |
| 510k Number | K896411 |
| Device Name: | REVISED PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. TRIHASTA LOKA PERSADA 10, JL. SURYOPRANOTO Jakarta - Indonesia, ID |
| Contact | Jamin Adiwarna |
| Correspondent | Jamin Adiwarna PT. TRIHASTA LOKA PERSADA 10, JL. SURYOPRANOTO Jakarta - Indonesia, ID |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-08 |
| Decision Date | 1989-12-20 |