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Isolation Gown

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

Description

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.

Front View

Isolation Gown

Slant View

Isolation Gown

Back View

Isolation Gown

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

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)

or

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

and

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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