510(k) Report

FDA applicant

Ammex Corporation

Kent, WA2 decisions1989–20210 recalls

FDA records 2 decisions for Ammex Corporation (Kent, WA) from 1989 to 2021: 2 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and LYY (Latex Patient Examination Glove). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ammex Corp.”.

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 Ammex Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ammex Corporation’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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Other applicant names beginning “Ammex”

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