510(k) Report

FDA applicant

Primus Gloves Pvt Limited

Cochin, IN3 decisions2016–20170 recalls

FDA records 3 decisions for Primus Gloves Pvt Limited (Cochin, IN) from 2016 to 2017: 3 510(k) clearances. Most are in product codes LZA (Polymer Patient Examination Glove) and KGO (Surgeon'S Gloves). Since 2016 its 510(k)s took a median of 236 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 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, general hospital panel, where it files most

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

FDA decisions per year

2in 2017

2016: 12017: 2
2016high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Primus Gloves Pvt Limited by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Primus Gloves Pvt Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LZAPolymer Patient Examination Glove1decision
  • KGOSurgeon'S Gloves1decision
  • LYZVinyl Patient Examination Glove1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 236 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 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.

  • K143477Nitrile Patient Examination gloves, Powderfree, Blue colorPrimus Gloves Pvt Limited · 20163cite it
  • K170515Sterile Nitrile Surgical Gloves, Powder-freePrimus Gloves Pvt Limited · 20171cites it

What has FDA decided for it lately?

  • K170612STERILE VINYL EXAMINATION GLOVES, Powder FreePrimus Gloves Pvt Limited · 2017
  • K170515Sterile Nitrile Surgical Gloves, Powder-freePrimus Gloves Pvt Limited · 2017
  • K143477Nitrile Patient Examination gloves, Powderfree, Blue colorPrimus Gloves Pvt Limited · 2016

All 3 as Primus Gloves Pvt Limited →

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 Private, Ltd. 4Primus Consulting 1Primus Corporation Dba Trinity Biotech 1