The following data is part of a premarket notification filed by Pt. Sarana Indoprotex with the FDA for Patient Examination Glovews.
| Device ID | K913531 |
| 510k Number | K913531 |
| Device Name: | PATIENT EXAMINATION GLOVEWS |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. SARANA INDOPROTEX JIN. IR. SUTAMI KM. 07. P.O. BOX 214 TNK, BANDAR Lampung 35001-iodonesia, IO |
| Contact | Tiong Gie |
| Correspondent | Tiong Gie PT. SARANA INDOPROTEX JIN. IR. SUTAMI KM. 07. P.O. BOX 214 TNK, BANDAR Lampung 35001-iodonesia, IO |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-08 |
| Decision Date | 1992-01-07 |