510(k) Report

FDA applicant

Shanghai Palomar Mountain Industries, Inc.

Songjiang Shanghai, CN12 decisions1999–20040 recalls

FDA records 12 decisions for Shanghai Palomar Mountain Industries, Inc. (Songjiang Shanghai, CN) from 1999 to 2004: 12 510(k) clearances. Most are in product codes LYZ (Vinyl 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 Shanghai Palomar Mountain Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Palomar Mountain Industries, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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