510(k) Report

FDA applicant

Heze Yuze Glove Co., Ltd.

Caoxian, CN1 decision2015–20150 recalls

FDA records 1 decision for Heze Yuze Glove Co., Ltd. (Caoxian, CN) in 2015: 1 510(k) clearance. All are in product code LYZ (Vinyl 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 Heze Yuze Glove Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Heze Yuze Glove Co., Ltd. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Heze”

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