510(k) Report

FDA applicant

Pt. Berlian Glovindo

Kec. Labuhan Batu - N. Sumatra, ID1 decision1999–19990 recalls

FDA records 1 decision for Pt. Berlian Glovindo (Kec. Labuhan Batu - N. Sumatra, ID) in 1999: 1 510(k) clearance. All are in product code LZA (Polymer Patient Examination Glove). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Pt. Berlian Glovindo’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pt. Berlian Glovindo since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Pt. Berlian Glovindo by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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