510(k) Report

FDA applicant

B-Care Industries Co., Ltd.

Littleton, CO2 decisions2005–20050 recalls

FDA records 2 decisions for B-Care Industries Co., Ltd. (Littleton, CO) in 2005: 2 510(k) clearances. Most are in product codes OPE (Unnamed device) and LYY (Latex 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 B-Care Industries Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for B-Care Industries Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — B-Care Industries Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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