510(k) Report

FDA applicant

Jiangsu Jaysun Glove Co., Ltd.

Haidian Dis, Beijing, CN3 decisions2006–20090 recalls

FDA records 3 decisions for Jiangsu Jaysun Glove Co., Ltd. (Haidian Dis, Beijing, CN) from 2006 to 2009: 3 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 3 predicates, 1 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 Jaysun Glove Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Jiangsu Jaysun Glove Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jiangsu Jaysun 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 Glove3decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K062522Powder-Free Vinyl Patient Examination GlovesJiangsu Jaysun Glove Co., Ltd. · 20061cites it

What has FDA decided for it lately?

  • K093570Powder Free Vinyl Patient Examination Gloves, Light Yellow ColorJiangsu Jaysun Glove Co., Ltd. · 2009
  • K062520Powdered Vinyl Patient Examination GlovesJiangsu Jaysun Glove Co., Ltd. · 2006
  • K062522Powder-Free Vinyl Patient Examination GlovesJiangsu Jaysun Glove Co., Ltd. · 2006

All 3 as Jiangsu Jaysun Glove Co., Ltd. →