510(k) Report

FDA applicant

Prolax Medical Products, Inc.

Great Neck, NY3 decisions1990–19900 recalls

FDA records 3 decisions for Prolax Medical Products, Inc. (Great Neck, NY) in 1990: 3 510(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 Prolax Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Prolax Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Prolax Medical Products, 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