510(k) Report

FDA applicant

P.T. Healthcare Glovindo

Jakarta, ID7 decisions1993–20020 recalls

FDA records 7 decisions for P.T. Healthcare Glovindo (Jakarta, ID) from 1993 to 2002: 7 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and 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 P.T. Healthcare Glovindo’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for P.T. Healthcare Glovindo since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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