The following data is part of a premarket notification filed by Pt. Indolex Karya Prakarsa with the FDA for Patient Examination Gloves (latex).
| Device ID | K892610 |
| 510k Number | K892610 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. INDOLEX KARYA PRAKARSA JLN. JEMBATAN TIGA PLUIT MAS BLOK BB 7-8 Jakarta 14450, Indonesia, ID |
| Contact | Alexander |
| Correspondent | Alexander PT. INDOLEX KARYA PRAKARSA JLN. JEMBATAN TIGA PLUIT MAS BLOK BB 7-8 Jakarta 14450, 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 | 1989-04-10 |
| Decision Date | 1989-09-18 |