The following data is part of a premarket notification filed by Pt. Scitech Industries with the FDA for Latex Examination Gloves.
| Device ID | K901148 |
| 510k Number | K901148 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. SCITECH INDUSTRIES 80. KAV.O.J1 GARUDA JAKARTA 10620 Indonesia, ID |
| Contact | Gustav A Husein |
| Correspondent | Gustav A Husein PT. SCITECH INDUSTRIES 80. KAV.O.J1 GARUDA JAKARTA 10620 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 | 1990-03-12 |
| Decision Date | 1990-04-09 |