510(k) Report

FDA applicant

Sun Flower Gloves Co., Ltd.

Tainan Hsien, Taiwan, TW3 decisions1989–20020 recalls

FDA records 3 decisions for Sun Flower Gloves Co., Ltd. (Tainan Hsien, Taiwan, TW) from 1989 to 2002: 3 510(k) clearances. 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 Sun Flower Gloves Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sun Flower Gloves Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sun Flower Gloves 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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