Objectives

The primary objective is to procure and deliver high-quality, sterile disposable surgical gowns to support clinical and infection control operations at Victoria Mxenge Hospital within the KwaZulu-Natal Provincial Department of Health.

Scope

• Item: Disposable sterile surgical gowns, Size Extra-Large (XL)
• Quantity: 15,000 units
• Delivery Location: Victoria Mxenge Hospital, KwaZulu-Natal
• Contract Duration: Once-off supply
• Quote Validity: 90 days from closing date
• Packaging: Sterile, individually double peel-packed, 50 gowns per carton

Technical Requirements

• Material & Construction: Non-woven polypropylene body (~54g/m²) with sleeves (~66g/m²); reinforced chest and forearm zones; liquid penetration resistant, lint-free, and non-flammable.
• Regulatory & Performance Standards: Must meet SANS 53795 (bacterial barrier efficiency), EU PPE Regulation 2016/425, EU MDD Directive 93/42/EEC, FDA Class I or II classification, EN 13795 (any performance level), and AAMI PB70 (all levels or equivalent).
• Quality Controls: Products must be new and unused; minimum six-month shelf life remaining upon delivery; expired goods strictly rejected.
• Documentation: Submission of a product brochure/specification sheet, SANS 53795 compliance certificate, and proof of Central Supplier Database (CSD) registration.
• Sampling: Physical samples required for independent testing and specification verification; testing costs borne by the bidder.

Skills Requirements

No formal professional certifications are mandated. Bidders must demonstrate:

• Established supply chain capabilities to source, store, and distribute medical-grade consumables reliably.
• Competence in compiling and submitting mandatory administrative, financial, and regulatory documentation accurately.
• Familiarity with South African public procurement frameworks, including compliance declarations and preferential scoring mechanisms.
• Logistical capacity to ensure timely, undamaged delivery to the designated hospital facility within agreed timeframes.

Key Terms & Clarifications

• 80/20 Preference Point System: An evaluation model allocating 80 points to price competitiveness and 20 points to transformation goals. Full 20 points are awarded to enterprises that are 100% South African-owned.
• AAMI PB70 / EN 13795 / SANS 53795: Internationally recognized standards measuring fluid resistance, bacterial filtration efficiency, and protective performance of surgical gowns used in clinical settings.
• Double Peel Pack: A sterile packaging method featuring two peelable layers that allows healthcare personnel to open the package without touching or contaminating the gown inside.
• CSD Registration: The Central Supplier Database, a mandatory National Treasury registry that all entities must join to conduct business with South African government departments.