510(k) Report

FDA applicant

Hebei Shenzichen Plastic & Rubber Products Co., LT

Beijing, CN2 decisions2010–20100 recalls

FDA records 2 decisions for Hebei Shenzichen Plastic & Rubber Products Co., LT (Beijing, CN) in 2010: 2 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 2 predicates, 0 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 Hebei Shenzichen Plastic & Rubber Products Co., LT’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010: 2
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Hebei Shenzichen Plastic & Rubber Products Co., LT 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

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K100963Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Hebei Shenzichen Plastic & Rubber Products Co., LT · 2010
  • K100964Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)Hebei Shenzichen Plastic & Rubber Products Co., LT · 2010

All 2 as Hebei Shenzichen Plastic & Rubber Products Co., LT →