510(k) Report

FDA applicant

Jiangsu Dongling Plastic & Rubber Co., Ltd.

Rd. Hai Di Beijing, CN2 decisions2011–20110 recalls

FDA records 2 decisions for Jiangsu Dongling Plastic & Rubber Co., Ltd. (Rd. Hai Di Beijing, CN) in 2011: 2 510(k) clearances. All are in product code LZA (Polymer 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 Dongling Plastic & Rubber Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2011: 2
2011high 2 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Jiangsu Dongling Plastic & Rubber Co., Ltd. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LZAPolymer 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:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K110248Powder Free Nitrile Patient Examination Gloves, White ColorJiangsu Dongling Plastic & Rubber Co., Ltd. · 20111cites it

What has FDA decided for it lately?

  • K110248Powder Free Nitrile Patient Examination Gloves, White ColorJiangsu Dongling Plastic & Rubber Co., Ltd. · 2011
  • K110247Powder Free Nutrile Patient Examination Gloves, Blue ColorJiangsu Dongling Plastic & Rubber Co., Ltd. · 2011

All 2 as Jiangsu Dongling Plastic & Rubber Co., Ltd. →