FDA applicant

Neo-Sigma, Inc.

Dallas, TX4 decisions1989–19890 recalls

FDA records 4 decisions for Neo-Sigma, Inc. (Dallas, TX) in 1989: 4 510(k) clearances. Most are in product codes LYZ (Vinyl Patient Examination Glove) and LYY (Latex 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 Neo-Sigma, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neo-Sigma, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Neo-Sigma, Inc.

Which product codes does it file in?

What has FDA decided for it lately?