Uncompromising Quality
Because a barrier is only as good as its weakest point.
International Standards
Our products are manufactured and tested to comply with stringent medical device regulations.
CE Marking
Compliant with European medical device directives.
ISO 13485:2016
Manufactured under a certified medical quality management system.
ASTM D6319
Meets standard specification for Nitrile examination gloves for medical application.
ASTM D3578
Meets standard specification for Rubber examination gloves.
EN 455 (1-4)
Meets European standards for single-use medical gloves.
FDA 510(k) Cleared
Cleared for medical use in the United States.
CDSCO Approved
Approved for medical use in India.
Our QA Process
From raw material to final dispatch.
1. Sourcing & Formulation
We begin with premium natural rubber latex or high-grade synthetic nitrile. Formulations are optimized for tensile strength without compromising elasticity.
2. Batch Testing at AQL 1.5
Acceptable Quality Level (AQL) 1.5 is the clinical standard. Batches are rigorously tested via water-leak and physical dimension checks to ensure barrier integrity.
3. Independent Inspection
Products undergo physical property testing (tensile strength, ultimate elongation) before and after accelerated aging to guarantee shelf-life performance.
4. Dispatch & Traceability
Every box is lot-traced. This ensures accountability and allows us to maintain consistent quality across all shipments.