510(k) Report

FDA applicant

Sanrea Healthcare Private Limited

Kerala, IN4 decisions2003–20030 recalls

FDA records 4 decisions for Sanrea Healthcare Private Limited (Kerala, IN) in 2003: 4 510(k) clearances. Most are in product codes KGO (Surgeon'S Gloves) and 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 and plastic surgery panel, where it files most

How often FDA has decided Sanrea Healthcare Private Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sanrea Healthcare Private Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sanrea Healthcare Private Limited by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • KGOSurgeon'S Gloves2decisions
  • LYYLatex Patient Examination Glove2decisions

What has FDA decided for it lately?

  • K023915Sterile Powdered Latex Patient Examination GlovesSanrea Healthcare Private Limited · 2003
  • K023910Sterile Patient Powderfree Latex Examination GlovesSanrea Healthcare Private Limited · 2003
  • K023912Powder Free Latex Surgeon's Gloves Contains 50 Megm or Less of Total Water Extractable Per GramSanrea Healthcare Private Limited · 2003
  • K023515Pre-Powdered Latex Surgeon's GlovesSanrea Healthcare Private Limited · 2003

All 4 as Sanrea Healthcare Private Limited →

Other applicant names beginning “Sanrea”

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

Sanrea Healthcare Products Pvt, Ltd. 3