510(k) Report

FDA applicant

Perlink USA, Inc.

Rye, NY6 decisions1990–19930 recalls

FDA records 6 decisions for Perlink USA, Inc. (Rye, NY) from 1990 to 1993: 6 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and FLK (Thermometer, Clinical Mercury). 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 Perlink USA, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Perlink USA, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Perlink USA, Inc.’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