510(k) Report

FDA applicant

Hebei Handform Plastic Products Co., Ltd.

Zhong Road; Beijing, CN4 decisions2009–20100 recalls

FDA records 4 decisions for Hebei Handform Plastic Products Co., Ltd. (Zhong Road; Beijing, CN) from 2009 to 2010: 4 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 4 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 Handform Plastic Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2009: 22010: 2
2009high 2 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Hebei Handform Plastic Products Co., Ltd. by year, 2009–2026Sources: 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

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K101358Powder-Free Vinyl Patient Examination GlovesHebei Handform Plastic Products Co., Ltd. · 2010
  • K101362Powder-Free Vinyl Patient Examination Gloves, Colored (Yellow)Hebei Handform Plastic Products Co., Ltd. · 2010
  • K082690Powder-Free Vinyl Patient Examination Gloves, Clear (Non-Colored)Hebei Handform Plastic Products Co., Ltd. · 2009
  • K082691Powdered Vinyl Patient Examination Gloves, Clear (Non-Colored)Hebei Handform Plastic Products Co., Ltd. · 2009

All 4 as Hebei Handform Plastic Products Co., Ltd. →