Objectives

The primary objective of this tender is to supply and deliver N95 masks that meet specified safety and quality standards to Vryheid Hospital, ensuring adequate protection against airborne infections in healthcare settings.

Scope

The scope includes the procurement of respiratory N95 masks, specifically designed to filter airborne particles with a bacterial filtration efficiency of at least 95%. The delivery is a once-off requirement to Vryheid Hospital, KwaZulu-Natal, within the specified contract period. The masks must conform to technical specifications, including material composition, filtration efficiency, packaging, and compliance with relevant standards and certifications.

Technical Requirements

• Product must be a medical device providing a barrier against airborne infections, tested according to SANS 1866:2004 type 2 standards.
• Must have valid NIOSH approval and certificates of compliance, with the product listed on the NIOSH website.
• Material Composition:
  • Four layers of non-woven material, ultrasonically bonded to a depth of 8mm.
  • Materials free from latex and glass, tested for bio-compatibility and skin irritation.
  • Inner and outer layers constructed via "wet lay" process.
• Design features:
  • Two latex-free securing bands of synthetic elastomeric material, 5mm wide.
  • Adjustable aluminum nose piece of 3mm width, flexible and malleable.
  • Polyurethane foam strip of 35mm width and 1mm thickness.
  • Designed to fit all facial structures and sizes, including use under full face shields.
• Filtration Efficiency:
  • Bacterial filtration efficiency (BFE) ≥ 95% at 0.3 micron.
  • Particle filtration efficiency (PFE) ≥ 95% at 0.1 micron.
  • Fluid resistance of 160 mm Hg.
• Packaging: 50 masks per box.

Skills Requirements

• Knowledge of medical device standards and certification processes, including SANS and NIOSH requirements.
• Technical expertise in materials testing, bio-compatibility, and skin irritation assessments.
• Experience in manufacturing or sourcing PPE masks that meet strict filtration and safety standards.
• Quality assurance skills to ensure compliance with specifications and certification documentation.
• Logistics and supply chain management skills for timely delivery to the hospital.