The following data is part of a premarket notification filed by Pt. Sarana Indoprotex with the FDA for Powder-free Exam Gloves.
| Device ID | K970773 |
| 510k Number | K970773 |
| Device Name: | POWDER-FREE EXAM GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. SARANA INDOPROTEX JL. IR. SUTAMI KM. 07 PO BOX 214 TNK, BANDAR Lampung 35001, ID 35001 |
| Contact | Md Yusof Bin Ibrahim |
| Correspondent | Md Yusof Bin Ibrahim PT. SARANA INDOPROTEX JL. IR. SUTAMI KM. 07 PO BOX 214 TNK, BANDAR Lampung 35001, ID 35001 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-12-04 |