510(k) Report

FDA applicant

Ocean Pacific Med Tec

Burnaby B C V5c 5a9, CA1 decision1989–19890 recalls

FDA records 1 decision for Ocean Pacific Med Tec (Burnaby B C V5c 5a9, CA) in 1989: 1 510(k) clearance. All are in product code 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 Ocean Pacific Med Tec’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ocean Pacific Med Tec since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ocean Pacific Med Tec by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Ocean”

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