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Isolation Gown

Quality protection from the risk of infection or contamination by blood, body fluids and other infectious substances.


Our disposable isolation gowns are strong enough for tough duties while still being comfortably breathable and flexible. The isolation gown features fully closed, double tie backs, with knitted cuffs easily can be worn with gloves to provide complete protection against light fluid contact. The isolation gown is made from lightweight, non-woven materials that ensures fluid resistance. Also, the disposable medical gowns are designed to fit men and women of all sizes while providing comfort and flexibility.

Medical Device Essential Requirements
Device Type Essential Technical Requirement Relevant Standards
Isolation Gown
- Single Use/Disposable
Design and Performance:
  • Should be made of well-established materials for this product area
  • The length must be mid-calf
  • Should have bonded seams unless not required for proposed non-surgical use
  • Should have resistance to penetration by liquids
  • Manufacturer must have quality management system in place such as evidence of compliance to ISO 9001 or BS EN 13485

High Performance Gowns
  • Protective performance against liquid hazards
  • Type PB[4] - B

Standard Performance Gowns
  • For use in areas of light splashing and aerosols
  • Limited protective performance against liquid hazards
  • Type PB[6]-B

Labelling & Packaging Information
  • Must state the type of gown
  • Must address the level of fluid resistance of the gown
  • Must include warnings on its use in certain areas (flammability) where appropriate
BS EN 14605:2005+A1: 2009 (Type 4 Suits – Spray tight)


BS EN 13034:2005+A1: 2009 (Type 6 Suits - Protection against liquid chemicals)


EN14126 (barrier to infective agents = B) Including ISO 16604 minimum level 2 Technical Specification Technical Specification to satisfy the requirements of Annex II of PPE Regulation (EU) 2016/425

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