510(k) Report

FDA applicant

Premier Pathway Sdn. Bhd.

Sparks, NV1 decision2000–20000 recalls

FDA records 1 decision for Premier Pathway Sdn. Bhd. (Sparks, NV) in 2000: 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 Premier Pathway Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Premier Pathway Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Premier Pathway Sdn. Bhd. 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

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.

  • K001327Powdered Latex Exam Gloves, Protein Labeling (150 Microgram or Less)Premier Pathway Sdn. Bhd. · 20001cites it

What has FDA decided for it lately?

  • K001327Powdered Latex Exam Gloves, Protein Labeling (150 Microgram or Less)Premier Pathway Sdn. Bhd. · 2000

The one decision as Premier Pathway Sdn. Bhd. →