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 medical disposables and surgical products are produced in facilities adhering to stringent international medical device manufacturing protocols.
CE Marking (MDR 2017/745)
Conformity marking for medical devices and sterile barrier products under European MDR regulations.
ISO 13485:2016
Medical Device Quality Management System governing raw material purity, cleanroom production, and lot traceability.
ASTM D6319
Standard specification for Nitrile Examination Gloves: tensile strength ≥ 14 MPa, elongation ≥ 500%, and AQL 1.5 water-leak integrity.
ASTM D3578
Standard specification for Natural Rubber Latex Gloves: tensile strength ≥ 18 MPa unaged / ≥ 14 MPa aged, elongation ≥ 650%, and low-protein limits.
EN 455 (Parts 1–4)
European standard for medical gloves: Part 1 (AQL 1.5 pinholes), Part 2 (Force at break ≥ 6N), Part 3 (Biological safety), Part 4 (Shelf life & aging).
ISO 11137 / ISO 11135
Sterilization of healthcare products (EO & Radiation), guaranteeing Sterility Assurance Level (SAL) 10⁻⁶ for operating theatre supplies.
CDSCO Approved (Class MD)
Central Drugs Standard Control Organisation regulatory approval for hospital, clinic, and institutional clinical distribution across India.
FDA 510(k) Cleared
Premarket medical notification establishing safety, barrier equivalence, and biocompatibility for clinical examination and surgical use.
EN 13795
European standard for surgical drapes and gowns, verifying liquid strike-through resistance and linting particulate defense in surgical suites.
ASTM F1671 / AAMI Level 4
Viral penetration resistance test using Phi-X174 bacteriophage, providing highest-tier defense against blood-borne pathogens.
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.