Surgical Gown – Extra High Performance

Description

PRODUCT DESCRIPTION:

The benefits of Sterile EXTRA Reinforced Surgical Gowns: ALL AREAS of Extra Reinforced Surgical Gowns are reinforced with a second layer for additional protection. It has the highest performance of all Surgical Gowns. In contrast, Reinforced Surgical Gowns are only reinforced with a second layer for additional protection on the chest and sleeves areas. In addition Extra Reinforced Gowns haVE PE/ Spunbond Reinforcement of 54 GSM while Reinforced Gowns has PE/Spunbond Reinforcement of 28 GSM. Extra Reinforced Gowns are made from Biflex Fabric (100% PE / Spunbond & Chemical Bond) materials and are fluid resistant.

TECHNICAL SPECIFICATIONS:

Extra Reinforced Surgical Gowns (Sterile): Extra High Performance:
– Hydrostatic Pressure >120cm H2O: High risk of exposure to fluids

CE MARKING:

• EN 13795:2019
• EN 11810:2015

Design and Performance:

• Manufactured from well-established materials which have considered flammability properties
• Validated as sterile – with Sterility Assurance Level (SAL) of 10^-6
• The length is mid-calf
• Has bonded seams
• Manufacturer has quality management system in place with compliance to ISO 9001 or BS EN 13485

High Performance gowns

• Hydrostatic pressure requirements (Liquid penetration): is above 120cm H₂O : tested to BS EN 13795.

Quality Certification Standards and Compliance
Quality Management Systems:	EN ISO 13485 EN ISO 9001
Product Certifications and Compliance:	CL 93/42/MDD Compliance with ASTM F 1980 Compliance with ASTM F 1929 Compliance with EN 868-5:2009 Compliance with EN ISO 11737-2
Production Area Compliance:	EN ISO 14698-1 EN ISO 14698-2
Machine Compliance:	EN ISO IEC 17025
Storage Conditions:	Keep in a cool and dry place protected from light
Guaranteed Storage Time:	3 Years after manufacturing

Product Description:

• Surgical Gown Universal (Pack of 80pcs and 100pcs)
• High protection for all-round use with a functional design.
• Our surgical gowns are available in Standard, Reinforced and Extra Reinforced and suitable for most procedures, made from breathable, textile-like, spunlace material that is comfortable to wear.
• Ergonomically designed shoulder pleats and sleeves give comfort and freedom of movement for the upper body, and arms. Gown cuffs are compatible with gloves, preventing gloves from sliding off.

Product Details:

• Lightweight and comfortable
• Ergonomic fit enables freedom of movement
• Adjustable neckline
• Breathable, textile-like spunlace materials comfortable to wear
• Specially treated to repel low-tension surface fluids
• Available in Standard or – for added protection against strike-through – High Performance:
• Exceeds EN13795 requirements for High Performance

Standards and Certifications:

• EN 146832019
• Compliance with EN ISO 868-5
• Stability according to ASTM F 1980
• Package leak tests according to ASTM F 1929
• Thermoforming line is validated for temperature and pressure settings according to EN IS0 17025.

Packaging:

• Product series name & product name
• Set type (dimensions and type of drape)
• Set contents with quantities
• Manufacturing date
• Date of expiry
• Let number
• Reference number
• Method of sterilization (the gown is sterile)
• Warnings (do not use if the package is damaged do not reuse, do not re-sterilize)
• Manufacturer contact & company information
• CE mark
• Supplied in packs of 80 & 100 gowns each