510(k) Report

FDA applicant

Suqian Xingye Glove Co,Ltd

Suqian City, CN2 decisions2016–20160 recalls

FDA records 2 decisions for Suqian Xingye Glove Co,Ltd (Suqian City, CN) in 2016: 2 510(k) clearances. All are in product code LZA (Polymer Patient Examination Glove). Its devices cite 1 predicate, 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 Suqian Xingye Glove Co,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2016: 2
2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Suqian Xingye Glove Co,Ltd by year, 2016–2026Sources: 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 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K151680Powder Free Nitrile Patient Examination Gloves, Blue ColorSuqian Xingye Glove Co,Ltd · 2016
  • K152271Powder Free Nitrile Patient Examination Gloves, Black colorSuqian Xingye Glove Co,Ltd · 2016

All 2 as Suqian Xingye Glove Co,Ltd →

Other applicant names beginning “Suqian”

FDA records each applicant name separately; these may or may not be the same firm.

Suqian Ruijang Medical Supplies Co., Ltd. 4Suqian Green Glove Co., Ltd. 2Suqian Clean Glove Co., Ltd. 1Suqian Linglian Medical Technology Co., Ltd. 1