510(k) Report

FDA applicant

Alatech Healthcare, LLC

Eufaula, AL4 decisions1999–20090 recalls

FDA records 4 decisions for Alatech Healthcare, LLC (Eufaula, AL) from 1999 to 2009: 4 510(k) clearances. Most are in product codes HIS (Condom) and LYY (Latex Patient Examination Glove). Its devices cite 1 predicate, 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Alatech Healthcare, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2009

2008: 12009: 2
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Alatech Healthcare, LLC 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?

  • HISCondom2decisions
  • LYYLatex Patient Examination Glove2decisions

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K083761Alatech Powder Free Latex Examination GloveAlatech Healthcare, LLC · 2009
  • K082529Alatech Champion Vytex Lubricated Male Latex CondomAlatech Healthcare, LLC · 2009
  • K080606Alatech Powdered Latex Patient Examination GloveAlatech Healthcare, LLC · 2008
  • K993887Alatech Latex CondomAlatech Healthcare, LLC · 1999

All 4 as Alatech Healthcare, LLC →