510(k) Report

FDA applicant

Qingdao Bestex Rubber & Plastic Products Co., Ltd.

Santa Clara, CA6 decisions2000–20220 recalls

FDA records 6 decisions for Qingdao Bestex Rubber & Plastic Products Co., Ltd. (Santa Clara, CA) from 2000 to 2022: 6 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and 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 Qingdao Bestex Rubber & Plastic Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Qingdao Bestex Rubber & Plastic Products Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Qingdao Bestex Rubber & Plastic…’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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