Full Reinforced Surgical Gowns

Ref. No: OP - 00203

Protective clothing, including surgical gowns, is subject to a number of standards and testing methods that all manufacturers must meet. These standards are set by AAMI (Association for the Advancement of Medical Instrumentation). Specifically, MDR (European Medical Device CRO) (EU) 2017:745, ISO 13795-1, ISO 10993-1/5, ISO EN 10993-10/12 standards and ANSI (American National Standards Institute)/AAMI PB70 in Europe :2012 is the standard that establishes a classification system (Level 1-4) based on liquid barrier performance, using standard test methods for protective clothing used in healthcare facilities, including surgical gowns. Europa (MDR) and the US Food and Drug Administration (FDA) have mandated that the standard, which all surgical gown manufacturers must comply with, be specifically published on and on the product packaging.

INSTRUCTIONS FOR USAGE

This gown can be used during the surgery operations. This product is disposable and it prevents the bacterial transfer between the medical team and the patient, reduces the occuring of possible contamination and infection between the patient and the medical team.

Does Opia Medikal offer AAMI Level 3 surgical gowns?

All Non-Reinforced, Fabric-Reinforced Surgical Gowns meet AATCC 42 and AATCC 127 AAMI Level 3 requirements in all four critical areas.

 

Protective clothing, including surgical gowns, is subject to a number of standards and testing methods that all manufacturers must meet. These standards are set by AAMI (Association for the Advancement of Medical Instrumentation). Specifically, MDR (European Medical Device CRO) (EU) 2017:745, ISO 13795-1, ISO 10993-1/5, ISO EN 10993-10/12 standards and ANSI (American National Standards Institute)/AAMI PB70 in Europe :2012 is the standard that establishes a classification system (Level 1-4) based on liquid barrier performance, using standard test methods for protective clothing used in healthcare facilities, including surgical gowns. Europa (MDR) and the US Food and Drug Administration (FDA) have mandated that the standard, which all surgical gown manufacturers must comply with, be specifically published on and on the product packaging.

INSTRUCTIONS FOR USAGE

This gown can be used during the surgery operations. This product is disposable and it prevents the bacterial transfer between the medical team and the patient, reduces the occuring of possible contamination and infection between the patient and the medical team.

Does Opia Medikal offer AAMI Level 3 surgical gowns?

All Non-Reinforced, Fabric-Reinforced Surgical Gowns meet AATCC 42 and AATCC 127 AAMI Level 3 requirements in all four critical areas.

 

Technical Standards

It is breathable, waterproof, lightweight and easy to wear. Knitted or elastic cuffs are used optionally. Our products can be easily used by patients' relatives, patients, nurses, doctors and laboratory workers. It is produced as a double-tie waist and neck-tied or velcro system.

Our products are produced as Sterile and Non-Sterile.

 

Certificates        : MDR, CE, FDA, ISO 13485, ISO 9001, ISO 13795-1

Fabric Type        : SMS (Spunbond + Meltblown + Spunond)

Usage Areas      : Hospitals, Chemical Factories, Petroleum Refineries, Construction Industry etc.

Colors                   : Medical Blue, Green, White

Weight                : 25 gsm, 30 gsm, 35 gsm, 40 gsm, 45 gsm, 50 gsm

Product sizes    : S, M, L, XL, XXL, XXXL

 

Packaging

Our products are packaged, and after all our products have passed the quality control, the phrase "Passed the Quality Control" is printed on it.

Box size : 40 x 60 x 40

Number of boxes: 80

Product Barcode

Parcel Barcode

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