510(k) Report

FDA applicant

Shijaizhuang Brilliant Ocean Plastic Co., Ltd.

Chino, CA3 decisions2004–20050 recalls

FDA records 3 decisions for Shijaizhuang Brilliant Ocean Plastic Co., Ltd. (Chino, CA) from 2004 to 2005: 3 510(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 Shijaizhuang Brilliant Ocean Plastic Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Shijaizhuang Brilliant Ocean Plastic Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Shijaizhuang Brilliant Ocean 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 Glove3decisions

What has FDA decided for it lately?

  • K043478Powdered Yellow Synthetic Vinyl Examination Gloves, Small, Medium, Large, X-LargeShijaizhuang Brilliant Ocean Plastic Co., Ltd. · 2005
  • K043499Powder Free Synthetic Vinyl Examination Gloves, Small, Medium, Large, X-LargeShijaizhuang Brilliant Ocean Plastic Co., Ltd. · 2005
  • K043159Powder Free Clear Synthetic Vinyl Examination Gloves, Small, Medium, Large, X-LargeShijaizhuang Brilliant Ocean Plastic Co., Ltd. · 2004

All 3 as Shijaizhuang Brilliant Ocean Plastic Co., Ltd. →