510(k) Report

FDA applicant

Zi BO Hong Wang Plastic & Rubber Products Co., Ltd.

North Billerica, MA2 decisions2004–20040 recalls

FDA records 2 decisions for Zi BO Hong Wang Plastic & Rubber Products Co., Ltd. (North Billerica, MA) in 2004: 2 510(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 Zi BO Hong Wang Plastic & Rubber Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zi BO Hong Wang Plastic & Rubber Products Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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