510(k) Report

FDA applicant

Gmax Industries, Inc.

Hauppauge, NY1 decision2018–20180 recalls

FDA records 1 decision for Gmax Industries, Inc. (Hauppauge, NY) in 2018: 1 510(k) clearance. All are in product code FYA (Gown, Surgical). Its devices cite 2 predicates, 0 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 and plastic surgery panel, where it files most

How often FDA has decided Gmax Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Gmax Industries, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FYAGown, Surgical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc. · 20185cite it

What has FDA decided for it lately?

  • K172987Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001)Gmax Industries, Inc. · 2018

The one decision as Gmax Industries, Inc. →