510(k) Report

FDA applicant

Thai Rayong Product Glove Zoupure Co., Ltd.

Bankhai, TH1 decision2022–20220 recalls

FDA records 1 decision for Thai Rayong Product Glove Zoupure Co., Ltd. (Bankhai, TH) in 2022: 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 Thai Rayong Product Glove Zoupure Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2022high 1 (2022) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Thai Rayong Product Glove Zoupure Co., Ltd. by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Thai”

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