510(k) Report

FDA applicant

Shanghai Champion Plastic Products Co., Ltd.

Sparks, NV6 decisions1999–20000 recalls

FDA records 6 decisions for Shanghai Champion Plastic Products Co., Ltd. (Sparks, NV) from 1999 to 2000: 6 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYZ (Vinyl 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 Champion Plastic Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Champion Plastic Products Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shanghai Champion Plastic Products Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shanghai Champion Plastic Products…’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