510(k) Report

FDA applicant

Jiangsu Alfa Glove Co., Ltd.

Haidian Dis, Beijing, CN2 decisions2008–20110 recalls

FDA records 2 decisions for Jiangsu Alfa Glove Co., Ltd. (Haidian Dis, Beijing, CN) from 2008 to 2011: 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 Jiangsu Alfa Glove Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2008: 12011: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Jiangsu Alfa Glove Co., Ltd. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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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?

  • K111459Powder Free Vinyl Patient Examination Gloves, Light Yellow ColorJiangsu Alfa Glove Co., Ltd. · 2011
  • K081658Powder-Free Vinyl Examination GlovesJiangsu Alfa Glove Co., Ltd. · 2008

All 2 as Jiangsu Alfa Glove Co., Ltd. →