Objectives

The primary objective of this tender is to procure Particulate Filter Respirator Masks (N95) that meet specified safety, quality, and performance standards for use in healthcare settings, particularly for protection against airborne infections such as pulmonary tuberculosis. The procurement aims to ensure the availability of masks that conform to national and international standards, are safe for users, and suitable for use with full face shields.

Scope

The scope includes the supply of 500 boxes of Particulate Filter Respirator Masks (N95) to GJGM Regional Hospital, KwaZulu-Natal. The masks must adhere to detailed specifications covering construction, materials, performance standards, and compliance with relevant standards (SANS, NIOSH). The procurement covers masks suitable for various facial structures, with specific requirements for construction, filtration efficiency, and usability in clinical environments.

Technical Requirements

• Type: Duckbill style, covering mouth, nose, and chin, with a secure fit.
• Materials: Non-woven, latex-free, glass-free, tested for bio-compatibility and skin irritation.
• Layers: Four ultrasonically bonded layers, not glued or stitched.
• Construction: Inner layers using wet lay process; elastic bands of synthetic elastomeric material; aluminum nose clip (3mm); polyurethane foam strip (35mm width, 1mm thickness).
• Standards: Must be tested and certified according to SANS 1866:2004 type 2, with valid NIOSH approval, and certificates submitted with bid.
• Filtration Efficiency: Bacterial filtration >95% at 0.3 micron; Particle filtration >95% at 0.1 micron; Fluid resistance at 160mm Hg.
• Labels: Must display NIOSH approval, model number, filter efficiency, and approval number.
• Compatibility: Suitable for use under full face shields and various facial sizes/shapes.

Skills Requirements

• Knowledge of medical device standards and compliance (SANS, NIOSH).
• Understanding of materials testing, bio-compatibility, and skin irritation testing.
• Ability to provide certification and documentation demonstrating compliance with standards.
• Experience in manufacturing or importing certified medical respiratory protective equipment.
• Capability to supply masks that meet performance standards and are suitable for clinical use.
• Proficiency in quality assurance, including testing, certification, and documentation submission.