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