Designation

Coverall

Description

Coverall available with selection of sizes.

Usage

EASY GOWN Coveralls are used for various inspection and protection purposes, especially in laboratories and industry.

Packing

Coveralls are packed in PE bags. Packages show the information below if requested:

• o Product series name & product name o Set type (dimensions and type of drape) o Set contents with quantities o Manufacturing date o Date of expiry (if applicable) o Lot number o Reference number
• o Warnings (don’t use open packages, for single use only, latex free) o Manufacturer contact & company information o CE Label

Sterility

Coveralls are offered as NON-STERILE.

 

Shelf Life

Coveralls have a shelf life of 5 years.

Quality Certification & Compliance

All process across SUBMED is run in compliance with EN ISO 9001 & EN ISO 13485.

All sterile products are manufactured in accordance with the below listed standards and norms. Independent third party laboratories tested EASY GOWN series for packing sealing strength is in compliance with EN ISO 868-5, stability according to ASTM F 1980 and package leak tests according to ASTM F 1929. Thermoforming line is validated for temperature and pressure settings according to EN ISO 17025.

Sterilization process has been validated according to EN ISO 11135-1, for sterilization by Ethylene Oxide. Sterilizer is also validated by IQ and OQ tests.

Our manufacturing plant and clean room is in compliance and been tested for EN ISO 11605, EN ISO 14644-1, EN ISO 14644-2, EN ISO 14698-1 and EN ISO 14698-2 tests for bio contamination levels in order to assure relevant safety levels in all products.

EASY GOWN series are tested for bio-burden according to EN ISO 11737-1. To achieve highest quality EO residue is also tested according to EN ISO 10993-7.

EASY GOWN series are manufactured in compliance with EN 13795:2011. According to EN 13795:2011, EASY GOWN series comply with EN ISO 22610:2006, EN ISO 11737-1:2006 + AC:2009, EN ISO 22612:2005, EN ISO 9073-10:2003, , EN 20811:1992, EN 13938:1999 and EN 29073-3:1992.

Coveralls are CE Class I products.

Content

Description	Qty.
Coverall	1

Materials of Selection

Coveralls can be made of from one of the below listed selections for gown:

o   Laminated Spunbond

All Coveralls have Velcro on backside of neck section.  Waists are with elastic cuff. Front side of coverall has a zipper. Coveralls can be selected only with:

o   Long Sleeves (Optional)

 

 

Available Dimensions

All Coveralls are available in standard sizes of S, M, L, XL and XXL.

It is possible to have different dimensions for certain quantities. Please request information from your Agent / Sales Representative.

Technical Drawing

 

Storage

Store the product under normal conditions for healthcare material, in a cool and dry place protected from light. The use of medical grade paper and film guarantees its sterility for the duration of its shelf life under normal transport and storage conditions.

Comments

The product must be used by specialised personnel only. Check the package’s integrity before use. Do not use if the package is open or damaged.