Objectives

The primary objective of this tender is to procure Sterile Gowns Level 4 that meet specified safety, sterility, and quality standards suitable for surgical procedures, ensuring protection for both patients and healthcare workers during major surgeries involving significant fluid and blood exposure.

Scope

The scope encompasses the supply of sterile, peel-packed surgeon gowns with reinforcement, non-woven fabric, fluid repellency, and specific sizing (XL and XXL). The gowns must conform to relevant standards (e.g., SANS 53795), be individually double packed, and include necessary accessories such as hand towels. The procurement is for a specified quantity of 50 units per size, with the gowns intended for daily orthopedic surgeries at Grey’s Hospital, KwaZulu-Natal.

Technical Requirements

• Gown material: Non-woven polypropylene, minimum 54 GSM for body, 66 GSM for sleeves, with certification stating material mass.
• Reinforcement: Inside front from chest to top of gown, and inside sleeve from cuff to full length.
• Fluid repellency: Certification stating fluid repellent properties, non-toxic, non-irritant, bacterial migration resistant, low linting, and low flammability.
• Design: Long sleeves with cuffs, approximately ¾ length (between ankle and mid-calf), in blue color.
• Packaging: Contents wrapped in a sterile, non-woven towel (minimum 600x600mm), packed in peel packs clearly marked with contents, expiry date, manufacturing date, and manufacturer details; individually double packed.
• Sterility certification: Must be provided.
• Additional items: Two (2) medical-grade, 2-ply, lint-free, high-absorbency (40 GSM) white hand towels, folded to minimum 300x200mm.
• Sizes: XL (148cm x 165cm x 70cm x 8cm) and XXL (150cm x 180cm x 70cm x 80cm x 8cm).
• Compliance: Must meet SANS 53795 standard and be suitable for daily orthopedic surgical use.

Skills and Capabilities Requirements

• Manufacturing capability to produce sterile surgical gowns with reinforced non-woven fabric, fluid repellency, and sterile packaging.
• Ability to provide certification of material specifications, sterility, and fluid repellency.
• Experience in packaging medical garments to maintain sterility during handling and storage.
• Compliance with relevant South African standards (e.g., SANS 53795).
• Provision of samples for evaluation and testing prior to bulk supply.
• Capacity to supply the specified quantities within the required delivery timeframe.
• Knowledge of regulatory requirements for medical device manufacturing and importation (e.g., SAHPRA licensing).