510(k) Report

FDA applicant

Shandong Perfect Plastic Co., Ltd.

Great Neck, NY2 decisions2004–20040 recalls

FDA records 2 decisions for Shandong Perfect Plastic Co., Ltd. (Great Neck, NY) in 2004: 2 510(k) clearances. All are in product code 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 Shandong Perfect Plastic Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shandong Perfect Plastic Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shandong Perfect Plastic 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 Glove2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K042213Pre-Powdered Non-Sterile Vinyl Examination GlovesShandong Perfect Plastic Co., Ltd. · 20041cites it

What has FDA decided for it lately?

  • K042214Powder-Free Non-Sterile Vinyl Examination GlovesShandong Perfect Plastic Co., Ltd. · 2004
  • K042213Pre-Powdered Non-Sterile Vinyl Examination GlovesShandong Perfect Plastic Co., Ltd. · 2004

All 2 as Shandong Perfect Plastic Co., Ltd. →