510(k) Report

FDA applicant

Tan Sin Lian Industries Sdn. Bhd.

Philadephia, PA2 decisions1999–20030 recalls

FDA records 2 decisions for Tan Sin Lian Industries Sdn. Bhd. (Philadephia, PA) from 1999 to 2003: 2 510(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, last Nov 3, 2026

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

How often FDA has decided Tan Sin Lian Industries Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tan Sin Lian Industries Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tan Sin Lian Industries Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tan Sin Lian Industries Sdn. Bhd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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