510(k) Report

FDA applicant

Shanghai Foremost Plastic Industrial Co., Ltd.

Songjiang County, Shanghai, CN4 decisions1997–20040 recalls

FDA records 4 decisions for Shanghai Foremost Plastic Industrial Co., Ltd. (Songjiang County, Shanghai, CN) from 1997 to 2004: 4 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 2 predicates, 2 of them its own earlier devices. 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 Foremost Plastic Industrial Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shanghai Foremost Plastic Industrial Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LYZVinyl Patient Examination Glove4decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K971415Vinyl Patient Examination Glove, Powder-FreeShanghai Foremost Plastic Industrial Co., Ltd. · 19972cite it

What has FDA decided for it lately?

  • K041041Non Sterile Synthetic Powder Free (Yellow) Vinyl Patient Examination GlovesShanghai Foremost Plastic Industrial Co., Ltd. · 2004
  • K032071Powder Free Vinyl Examination GloveShanghai Foremost Plastic Industrial Co., Ltd. · 2003
  • K971423Vinyl Patient Examination Glove, PowderedShanghai Foremost Plastic Industrial Co., Ltd. · 1997
  • K971415Vinyl Patient Examination Glove, Powder-FreeShanghai Foremost Plastic Industrial Co., Ltd. · 1997

All 4 as Shanghai Foremost Plastic Industrial Co., Ltd. →