FDA applicant
Pt. Sarana Indoprotex
FDA records 4 decisions for Pt. Sarana Indoprotex (Indonesia, ID) from 1992 to 1998: 4 510(k) clearances. All are in product code LYY (Latex Patient Examination Glove). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pt. Sarana Indoprotex’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pt. Sarana Indoprotex since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pt. Sarana Indoprotex’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report