Quality & Certifications

Standards alignment for hospital procurement, county tenders and quality committee reviews.

Regulatory Framework

We source from manufacturers with recognised medical device quality systems. Certificate copies are available to qualified buyers for tenders.

CE Marking

Surgical and examination glove lines carry CE marking pathways appropriate to medical device classification. Technical documentation supports hospital quality files.

ISO 13485

Manufacturing partners operate under ISO 13485 medical device quality management systems covering design, production and batch release controls.

EN 455 Series

European standards for medical gloves covering freedom from holes, physical properties, biological evaluation and shelf-life requirements for surgical use.

ASTM Standards

Surgical latex and nitrile examination lines target ASTM performance criteria (e.g. D3577 surgical, D6319 nitrile examination) as applicable by product.

Quality Process Timeline

From manufacturer batch release to delivery at your hospital store.

  1. Design & Spec Control

    Product specifications define material, AQL, dimensions, cuff style and packaging for each glove line.

  2. Component & Material Control

    Latex, nitrile and synthetic compounds are controlled at source under the manufacturer's quality system.

  3. Manufacturing

    Dipping, curing, leaching, powdering or polymer coating, and cuff forming follow validated process steps.

  4. Testing

    Freedom-from-holes, tensile strength, elongation and water-tight tests are performed per lot as required.

  5. Sterilisation & QC Release

    Sterile pairs undergo validated sterilisation with lot traceability before release to export packing.

  6. Packaging

    Peel pouches and outer cartons protect barrier integrity through international and local logistics.

  7. Kenya Dispatch

    Our Nairobi hub inspects inbound stock, stores correctly, and ships to facilities with requested certificates.

Need certificates for a tender?

Send the tender reference, product list and facility name. We prepare compliant document packs promptly.

Request Documentation

Quality you can file with confidence

Partner with a supplier that treats compliance as part of delivery, not an afterthought.

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