510(k) Report

FDA applicant

Ssl Americas, Inc. (Regent Medical)

Norcross, GA1 decision2000–20001 recall

FDA records 1 decision for Ssl Americas, Inc. (Regent Medical) (Norcross, GA) in 2000: 1 510(k) clearance. All are in product code KGO (Surgeon'S Gloves). 1 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 Ssl Americas, Inc. (Regent Medical)’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ssl Americas, Inc. (Regent Medical) since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ssl Americas, Inc. (Regent Medical) 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.

  • K000421Biogel Neotech II Powder-Free Neoprene Surgeon's GloveSsl Americas, Inc. (Regent Medical) · 20001cites it

What has FDA decided for it lately?

  • K000421Biogel Neotech II Powder-Free Neoprene Surgeon's GloveSsl Americas, Inc. (Regent Medical) · 20001 recall

The one decision as Ssl Americas, Inc. (Regent Medical) →

What has been recalled?

1 recall linked to its devices; the latest:

  • K000421Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating…Nov 25, 2002