Uncompromising Standards for Every Batch
Because a protective barrier is only as good as its weakest point. We enforce AQL 1.5 testing across all inventory.
International Medical Device Standards
APbiosense gloves are produced in facilities adhering to stringent international medical device manufacturing protocols.
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 4-Stage Quality Assurance Protocol
From raw synthetic/natural material formulation to final sealed dispatch.
Raw Material Sourcing & Formulation
High-grade synthetic nitrile polymer or pure natural rubber latex is tested for purity, tensile baseline, and absence of prohibited accelerators.
Water-Leak Batch Testing at AQL 1.5
Acceptable Quality Level 1.5 requires randomized water-tightness testing under hydrostatic pressure to eliminate micro-pinhole defects.
Physical Property & Accelerated Aging
Tensile strength (MPa) and ultimate elongation tests before and after thermal aging to guarantee durable shelf-life barrier performance.
Lot Traceability & Hermetic Packaging
Every production lot is assigned a traceable batch code, inspection certificate, and packaged in moisture-barrier clinical boxes.