Disposable Coverall, Surgical Mask, Level 3 and Level 4 Surgical Gown

Products

Standards

Bodygard disposable coveralls are manufactured on and in accordance with the following standards:

• Passes EN1149-5 for antistatic properties
• Passes EN1073-2 for protection against radioactive particulate contamination
• Passes EN 14126 for protection against biological hazards and infective agents
• Complies with EN 374-3:2003 standard for protection against chemicals
• Conforms to Category 3 - Complex Design Personal Protective Equipment PPE Directive 89/686/EEC
• Tested against standard EN ISO 14605+A1:2009 spray tight protection (Type 4)
• Tested against standard EN ISO 13982-1+A1:2010 particle tight protection (Type 5)
• Tested against standard EN ISO 13034:2005 limited splash protection (Type 6).

Sterile Surgical Gowns

• AAMI Level 3 surgical gown
• AAMI Level 4 surgical gown
• AATCC 42
• AATCC 127
• ASTM 1670
• ASTM 1671
• EN 13795 High performance
• EN ISO 11737-1: 2017/ TS EN ISO 11737-1:2018
• EN 22610:2006
• EN 29073-3: 1996
• ISO 13938-1: 1999
• ISO 811:2018
• ISO 16603:2004
• EN ISO 6530:2005
• EN 863: 1995
• ISO 13935-2: 2014

Surgical Masks

• Bacterial Filtration Efficiency
• Differential Pressure for breathability
• Synthetic Blood Penetration for Face Masks
• Microbial Cleanliness for Face Masks
• Cytotoxicity, Sensitization , Irritation
• EN 14683 Type II
• EN 14683: 2019 +AC : 2019 ( TS EN 14683+AC:2019) EK-B
• EN ISO 11737-1:2018 / TS EN ISO 11737-1 : 2018

BODYGARD Extra Comfort Scrub Suit

• For extra softness, choose our Extra Comfort scrubs made from SUPERSOFT®, a unique nonwoven material that is lightweight and also transfers moisture away from the skin.
• Single-use for a new, fresh start every day
• Lower air and wound bacterial contamination than conventional cotton shirts and trousers 1
• Made from low linting materials in a clean production environment to reduce the risk of contamination
• Scrub suits are comfortable, and transfer moisture away from the skin

Bodygard  FDA 510 K

Bodygard SFS Surgical Gown LEVEL 3 is now FDA 510K approved. We are honored to be the first FDA 510K awarded surgical gown brand in Turkey. FDA 510K clearance provides added safety and higher quality regulation to our products.

ASTM Level 3 surgical gowns manufactured by Bodygard have recently received 510(k) approval from the US Food and Drug Administration (FDA). Surgical Gowns are designed to be used by healthcare professionals to protect both the patient and themselves from the contamination of microorganisms, body fluids and particulate matter. Surgical Gowns are designed for use in infection control applications to reduce possible exposure to blood and body fluids.

For the US market, Bodygard now provides FDA 510K approved surgical gowns that meet the American Society for Testing and Materials (ASTM) Level 3 standard. PB70 AAMI ,the ASTM Level 3 surgical gown is for use in  Moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure). Masks are a single-use, disposable device supplied non-sterile.

PB70

"Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities"

Description

Overview: This standard establishes a system of classification for protective apparel and drapes used in health care facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance.

he ANSI/AAMI PB70 standard includes four standard tests to evaluate the barrier effectiveness of surgical gowns, isolation gowns, and surgical drapes. Based on the results of these standardized tests, four levels of barrier performance are defined, with Level 1 being the lowest level of protection, and Level 4 being the highest level of protection. Table 3 summarizes the requirements of ANSI/AAMI PB70:2012 regarding the classification of barrier performance of surgical gowns, isolation gowns, and surgical drapes.

Table 3: ANSI/AAMI PB 70:12 classification of barrier performance of surgical gowns, other protective apparel, surgical drapes and drape accessories

Level1

Personal Protective Equipment

Body Protection

All items of clothing and/or accessories (whether or not detachable) designed and manufactured to provide specific protection. This includes bullet-proof clothing, general protective clothing and full body ensembles that protect from cuts, radiation, temperature extremes, hot splashes from molten metals and other hot liquids, potential impacts from tools, machinery and materials and hazardous chemicals. Examples of body protection include laboratory coats, coveralls, vests, jackets, aprons, surgical gowns and full body suits

• Medical protective clothing
• Coveralls
• Apron
• Gowns
• Drapes

Bodgard`s surgical Gowns were tested for performance in four areas: impact penetration, hydrostatic pressure, Synthetic blood penetration, and Viral Penetration tets under PB70. Upon completion of testing, the surgical gowns consistently met ASTM Level 3 criteria in all four performance test areas. Synthetic Blood Penetration and Virus penetration test efficiency test results were more than 99 percent.

“This has been a huge success for our team. This is a milestone that supports our commitment to continue to produce high-performance products. Meeting the ASTM Level 3 standard is a stable, reliable way to not only keep our healthcare workers safe but also ensure that famines that occurred at the start of the pandemic don't happen again. It helps us in our goal of ensuring they have a supply of PPE."

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