510(k) Report

FDA applicant

Mdm Enterprise Corp.

Rancho Cucamonga, CA1 decision2004–20040 recalls

FDA records 1 decision for Mdm Enterprise Corp. (Rancho Cucamonga, CA) in 2004: 1 510(k) clearance. 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 Mdm Enterprise Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mdm Enterprise Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LYZVinyl Patient Examination Glove1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K033835Disposable Powder Free Vinyl Synthetic Examination Glove, White ColorMdm Enterprise Corp. · 20042cite it

What has FDA decided for it lately?

  • K033835Disposable Powder Free Vinyl Synthetic Examination Glove, White ColorMdm Enterprise Corp. · 2004

The one decision as Mdm Enterprise Corp. →