510(k) Report

FDA applicant

Jiangsu Sunshine Plastic Products, Co., Ltd.

Taipei County, TW4 decisions2010–20100 recalls

FDA records 4 decisions for Jiangsu Sunshine Plastic Products, Co., Ltd. (Taipei County, TW) in 2010: 4 510(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 Jiangsu Sunshine Plastic Products, Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

4in 2010

2010: 4
2010high 4 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Jiangsu Sunshine Plastic Products, Co., Ltd. by year, 2010–2026Sources: 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 Glove2decisions
  • LZAPolymer Patient Examination Glove2decisions

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K100978Powder Free Non-Sterile Vinyl Examination GloveJiangsu Sunshine Plastic Products, Co., Ltd. · 20104cite it

What has FDA decided for it lately?

  • K100975Nitril Exam Glove, Pre-Powered Color White, Nitrile Exam Glove, Pre-Powdered, Color BlueJiangsu Sunshine Plastic Products, Co., Ltd. · 2010
  • K100977Pre-Powdered Vinyl Patient Examination Glove, Non-SterileJiangsu Sunshine Plastic Products, Co., Ltd. · 2010
  • K100978Powder Free Non-Sterile Vinyl Examination GloveJiangsu Sunshine Plastic Products, Co., Ltd. · 2010
  • K100979Nitrile Exam Glove, Powder-Free Model Color White, Nitrile Exam Glove, Powder-Free Model Color BlueJiangsu Sunshine Plastic Products, Co., Ltd. · 2010

All 4 as Jiangsu Sunshine Plastic Products, Co., Ltd. →