510(k) Report

FDA applicant

Bettercare Plastic Products Co., Ltd.

Chino, CA4 decisions2009–20100 recalls

FDA records 4 decisions for Bettercare Plastic Products Co., Ltd. (Chino, CA) 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 Bettercare Plastic Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 32010: 1
2009high 3 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Bettercare Plastic Products Co., Ltd. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bettercare Plastic Products Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

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:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K092296Powder Free Examination GloveBettercare Plastic Products Co., Ltd. · 20092cite it
  • K092301Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink)Bettercare Plastic Products Co., Ltd. · 20091cites it

What has FDA decided for it lately?

  • K092302Powder Free Vinyl Synthetic Examination Gloves with Aloe Vera, Green ColorBettercare Plastic Products Co., Ltd. · 2010
  • K092301Powder Free Vinyl Patient Examination Gloves, (Yellow, White, Blue, Pink)Bettercare Plastic Products Co., Ltd. · 2009
  • K092294Vinyl CO-Polmer Free Examination Gloves, Blue ColorBettercare Plastic Products Co., Ltd. · 2009
  • K092296Powder Free Examination GloveBettercare Plastic Products Co., Ltd. · 2009

All 4 as Bettercare Plastic Products Co., Ltd. →