510(k) Report

FDA applicant

Shandong Feiyang Professional Gloves Co., Ltd.

Qingzhou, CN1 decision2017–20170 recalls

FDA records 1 decision for Shandong Feiyang Professional Gloves Co., Ltd. (Qingzhou, CN) in 2017: 1 510(k) clearance. All are in product code LZA (Polymer Patient Examination Glove). 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 Shandong Feiyang Professional Gloves Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Shandong Feiyang Professional Gloves Co., Ltd. by year, 2017–2026Sources: 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 Glove1decision

What has FDA decided for it lately?

  • K170136Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy…Shandong Feiyang Professional Gloves Co., Ltd. · 2017

The one decision as Shandong Feiyang Professional Gloves Co., Ltd. →