510(k) Report

FDA applicant

H.B.M. USA Co.,Inc.

Queen'S Village, NY1 decision2005–20050 recalls

FDA records 1 decision for H.B.M. USA Co.,Inc. (Queen'S Village, NY) in 2005: 1 510(k) clearance. All are in product code KGO (Surgeon'S Gloves). 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 H.B.M. USA Co.,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for H.B.M. USA Co.,Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — H.B.M. USA Co.,Inc. 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?

  • KGOSurgeon'S Gloves1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K050071Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc. · 20051cites it

What has FDA decided for it lately?

  • K050071Medispo (Powdered) and Medispo-PF (Powder-Free) Surgeons GloveH.B.M. USA Co.,Inc. · 2005

The one decision as H.B.M. USA Co.,Inc. →