510(k) Report

FDA applicant

Premium Fit

Dallas, TX1 decision1990–19900 recalls

FDA records 1 decision for Premium Fit (Dallas, TX) in 1990: 1 510(k) clearance. All are in product code 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 Premium Fit’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Premium Fit since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Premium Fit 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?

  • LYYLatex Patient Examination Glove1decision

What has FDA decided for it lately?

  • K900499Latex Patient Examination GlovesPremium Fit · 1990

The one decision as Premium Fit →

Other applicant names beginning “Premium”

FDA records each applicant name separately; these may or may not be the same firm.

Premium Plastics, Inc. 9Premium Plus International Limited 4Premium Plus (Dongguan) Limited 3Premium Medical Technology, LLC 1Premium Source Merchandising 1