The following data is part of a premarket notification filed by Pt. Sarana Indoprotex with the FDA for Low Protein Latex Patient Examination Gloves (powder-free).
| Device ID | K980605 |
| 510k Number | K980605 |
| Device Name: | LOW PROTEIN LATEX PATIENT EXAMINATION GLOVES (POWDER-FREE) |
| Classification | Latex Patient Examination Glove |
| Applicant | PT. SARANA INDOPROTEX JALAN IR. SUTAMI KM. 7 LEMATANG Bandar, Lampung, ID 35001 |
| Contact | Ellen Hutapea |
| Correspondent | Ellen Hutapea PT. SARANA INDOPROTEX JALAN IR. SUTAMI KM. 7 LEMATANG Bandar, Lampung, 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 | 1998-02-17 |
| Decision Date | 1998-04-14 |