510(k) Report

FDA applicant

Primus Gloves Private, Ltd.

Kakkanad, Cochin, Kerala, IN4 decisions2002–20030 recalls

FDA records 4 decisions for Primus Gloves Private, Ltd. (Kakkanad, Cochin, Kerala, IN) from 2002 to 2003: 4 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and LYZ (Vinyl 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 and plastic surgery panel, where it files most

How often FDA has decided Primus Gloves Private, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Primus Gloves Private, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Primus Gloves Private, Ltd. 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 Gloves3decisions
  • LYZVinyl 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.

  • K021065Pre-Powdered Sterile Surgeon's Gloves (with a 50 Microgram/GM Protein ClaimPrimus Gloves Private, Ltd. · 20021cites it

What has FDA decided for it lately?

  • K030444Pre-Powdered Latex Orthopedic Surgeon's GlovesPrimus Gloves Private, Ltd. · 2003
  • K030445Powder Free Latex Microsurgery Gloves with Brown Color and Protein Labeling Claim of 50 Micrograms or Less…Primus Gloves Private, Ltd. · 2003
  • K021065Pre-Powdered Sterile Surgeon's Gloves (with a 50 Microgram/GM Protein ClaimPrimus Gloves Private, Ltd. · 2002
  • K020044Vinyl Examination Gloves Sterile PowederedPrimus Gloves Private, Ltd. · 2002

All 4 as Primus Gloves Private, Ltd. →

Other applicant names beginning “Primus”

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

Primus Corp. 14Primus Sterilizer Company, LLC 6Primus Gloves Pvt Limited 3Primus Consulting 1Primus Corporation Dba Trinity Biotech 1