Impervious Surgical Gown (ONE SIZE)

Impervious Surgical Gown

Size: ONE SIZE

Colour: BLUE

• Disposable Gown, Fluid Resistant.
• Elasticated Cuffs.
• Extra Length on the waist ties allowing the Gown to be easily Secured.
• Single use – NON Sterile.
• CE approved.

Usage

SUBMED Surgical Gowns are used to reduce risk of infection and create a layer of protection for both

for surgeons and patients. Reinforced, Full Reinforced and Extra Reinforced, Surgical Gowns have

reinforced with an extra layer.

Transport

Gowns are transported in a carton boxes. Basic warnings and information is printed on cartons with

manufacturer information and contact details. CE marking and name of set can be seen on carton boxes.

Packing

All components are packed in operational order so that efficiency is ensured.

Depending on the preference 3 options are available for sterile and nonsterile gowns:

• Pouch Pack: Sterile Gowns are packed in a pouch with size depending on the selection of

dimension and type of folding requested. Pouch has necessary peeling opening available.

• Blister Pack: Sterile Gowns are packed inside a blister pack. Blister pack has a peeling side

marked.

• PE Bag : Nonsterile gowns are packed in PE bags.

In these packing methods, packages show the information below:

• Product series name & product name
• Set type (dimensions and type of drape)
• Set contents with quantities
• Manufacturing date
• Date of expiry
• Lot number
• Reference number
• Method of sterilization (if gown is sterile)
• Warnings (don’t use if package is damaged, don’t reuse, don’t re-sterile etc.)
• Manufacturer contact & company information
• CE mark

Sterility

Sterile Surgical Gowns are sterilized with EO sterilizer in house. Sterilization is documented and

monitored through necessary forms, biological indicators, chemical indicators and data loggers.

It is possible to have Nonsterile products upon request with same variety of selections from sizes and

materials available.

Shelf Life

Product has been tested for stability. Test reports show that Sterile Surgical Gowns have a shelf life of 3

years and Nonsterile Surgical Gowns have a shelf life of 5 years.

Quality Certification & Compliance

All process across SUBMED is run in compliance with EN ISO 13485:2016.

Independent thirdparty laboratories tested SUBMED 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.

SUBMED 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.

SUBMED GOWN series are manufactured in compliance with EN 13795. According to EN 13795,

SUBMED GOWN series comply with EN ISO 22610, EN ISO 11737-1, EN ISO 22612, EN ISO 9073-10, EN

20811, EN 13938 and EN 29073-3.

Sterile Surgical Gowns are CE Class IS and Nonsterile Surgical Gowns are Class I nonsterile products.