Objectives

The primary objective is to secure a one-off supply of certified N95 surgical particulate respirators for clinical deployment at King Dinuzulu Hospital. The procurement aims to protect healthcare personnel against airborne infectious agents (particularly tuberculosis), fluid splashes, and particulate hazards during routine patient care and aerosol-generating medical procedures.

Scope

The scope encompasses the supply, packaging, and delivery of exactly 19,985 individual respirators to the hospital complex. This is a single-delivery contract with a ninety-day price validity period. All delivery costs must be factored into the quoted price. Supplied stock must be brand new, unused, and retain a minimum shelf life of six months from the date of receipt at the facility. Expired, used, or second-hand products will be rejected outright.

Technical Requirements

Bidders must strictly comply with the following design, performance, and regulatory specifications:

• Design & Construction: Only duckbill/pouch-style masks are acceptable. Cup, cone, or vertical flat-fold designs are non-compliant. Masks must feature a 4–5 layer pleated composite filter, a fluid-resistant outer barrier, melt-blown filtration media, and an ultra-soft inner lining to minimize skin irritation. Headbands must be heavy-duty, highly elastic, and permanently sonic-bonded or welded to the mask body (staples are prohibited). A malleable nose wire is mandatory. All components must be latex-free, DEHP-free, and pass ISO 10993-10 biocompatibility testing for skin irritation.
• Performance Metrics: Particulate Filtration Efficiency (PFE) must be ≥95% against non-oil-based particles down to 0.3 microns. Bacterial Filtration Efficiency (BFE) must be ≥99%. The product must demonstrate verified fluid resistance and splash protection suitable for surgical environments.
• Regulatory Certifications: Products must hold active approvals from multiple regulatory bodies:
  • NIOSH Approval: Certified under 42 CFR Part 84 as an N95 respirator, with the official approval number clearly printed on every unit and packaging.
  • FDA Clearance: Cleared as a Class II medical device for surgical mask use.
  • NRCS Pre-Approval: Valid Letter of Authority from the National Regulator for Compulsory Specifications for respiratory protective devices.
  • SAHPRA Registration: Actively registered as a Class B/II medical device with the South African Health Products Regulatory Authority.
• Packaging & Documentation: Items must be packed at 35 units per dispenser box and 210 units per shipping carton. Final delivery must total exactly 19,985 units. Quotations must be accompanied by a Technical Data Sheet, certified NIOSH certificate, FDA 510(k) clearance, NRCS Letter of Authority, SAHPRA registration proof, and a physical sample from the exact manufacturing lot.

Skills Requirements

As this tender relates to the supply of goods rather than specialized services, no formal professional qualifications or human resource skills are mandated. However, bidders must demonstrate operational and compliance capabilities, including:

• Proven logistical capacity to handle bulk procurement, maintain product integrity, and execute timely deliveries to government facilities.
• Documented experience supplying similar medical PPE to public sector entities, evidenced by at least three recent order and delivery confirmations.
• Competence in navigating South African public procurement frameworks, including Central Supplier Database (CSD) verification, B-BBEE status documentation, and CIPC corporate registration.

Procurement Note: Evaluation utilizes an 80/20 preference point system, awarding 80 points for competitive pricing and 20 points for socio-economic goals (specifically, ownership by South African enterprises). Claiming these points requires verifiable proof via CSD and CIPC records. Failure to submit mandatory administrative forms, regulatory certificates, or requested samples will result in immediate disqualification.