510(k) Report

FDA applicant

Yulex Corporation

Maricopa, AZ1 decision2008–20080 recalls

FDA records 1 decision for Yulex Corporation (Maricopa, AZ) in 2008: 1 510(k) clearance. All are in product code OIG (Powder-Free Guayle Rubber 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 Yulex Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Yulex Corporation by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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