The following data is part of a premarket notification filed by Pt. Indorub Nusaraya with the FDA for Unicare Latex Examination Gloves.
| Device ID | K894972 |
| 510k Number | K894972 |
| Device Name: | UNICARE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. INDORUB NUSARAYA JL. SEMARANG NO. 105/16 Medan, Sumatera Utara, ID 20212 |
| Contact | Santoso Lutan |
| Correspondent | Santoso Lutan PT. INDORUB NUSARAYA JL. SEMARANG NO. 105/16 Medan, Sumatera Utara, ID 20212 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-07 |
| Decision Date | 1989-09-12 |