The following data is part of a premarket notification filed by Pt. Herlin Dharma Persada with the FDA for Topclean Patient Examination Gloves.
| Device ID | K893158 |
| 510k Number | K893158 |
| Device Name: | TOPCLEAN PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. HERLIN DHARMA PERSADA JL. SUKARJO WIRYOPRANOTO 42 Jakarta, ID |
| Contact | Herman Kurniadjaja |
| Correspondent | Herman Kurniadjaja PT. HERLIN DHARMA PERSADA JL. SUKARJO WIRYOPRANOTO 42 Jakarta, ID |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-14 |
| Decision Date | 1989-09-13 |