510(k) Report

FDA applicant

Glormed Intl., Inc.

Sparks, NV6 decisions1998–20040 recalls

FDA records 6 decisions for Glormed Intl., Inc. (Sparks, NV) from 1998 to 2004: 6 510(k) clearances. All are in product code LYZ (Vinyl Patient Examination Glove). Its devices cite 6 predicates, 5 of them its own earlier devices. 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 Glormed Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Glormed Intl., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Glormed Intl., Inc.’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 “Glormed”

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