510(k) Report

FDA applicant

Derlin Company, Ltd.

Ming Sheng E. Rd. Taipei, TW2 decisions1997–19970 recalls

FDA records 2 decisions for Derlin Company, Ltd. (Ming Sheng E. Rd. Taipei, TW) in 1997: 2 510(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 Derlin Company, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Derlin Company, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Derlin Company, Ltd.’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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