You are Safe with Bodygard!
BODYGARD SFS LEVEL 3 surgical gowns are available in EN 13795 High Performance/ AAMI LEVEL 3 gowns and suitable for most procedures. BODYGARD surgical gowns SFS65 LEVEL 3 are made from a breathable, textile-like, Superfiber spunbond material that is comfortable to wear.
BODYGARD SFS LEVEL 4 surgical gowns are available in EN 13795 High Performance/ AAMI LEVEL 4 gowns and suitable for most procedures. BODYGARD surgical gowns SFS65 LEVEL 4 are made from a breathable, textile-like, Superfiber spunbond material that is comfortable to wear.
Bodygard disposable coverall confirms with category III Type5 and Type 6 . Our disposable coveralls are used in painters suit, disposable chemical protection suits, ebola protection kits, swine flue protection coveralls, ebola coveralls and many more protection applications.
Bodygard Disposable Drape Packs are ;
General Surgery Drape Pack / Set up Packs / Basic Packs / Universal Packs / Universal Split Packs / Laparotomy Pack / Laparotomy drape / Transverse Laparotomy Laparotomy Incise Drape / Minor Procedure Drape / Adolescents Laparotomy drape / Thyroid Drape / Chest/Breast Drape / Laparoscopic Abdominal Drape / General Endoscopy Drape / Bariatric Drape / Major Abdominal drape with pouches
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
- 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.
"Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities"
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||Test||Liquid Challenge||Result||Expected Barrier Effectiveness|
|1||AATCC 42 Impact Penetration2||Water||= 4.5 g||Minimal water resistance (some resistance to water spray)|
|2||AATCC 42 Impact Penetration||Water||= 1.0 g||Low water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)|
|AATCC 127 Hydrostatic Pressure3||Water||= 20 cm|
|3||AATCC 42 Impact Penetration||Water||= 1.0 g||Moderate water resistance (resistant to water spray and some resistance to water penetration under constant contact with increasing pressure)|
|AATCC 127 Hydrostatic Pressure||Water||= 50 cm|
|4||ASTM F1670 Synthetic Blood Penetration Test (for surgical drapes)||Surrogate Blood||no penetration at 2 psi(13.8 kPa)||Blood and viral penetration resistance (2 psi)|
|ASTM F1671 Viral Penetration Test (for surgical and isolation gowns)||Bacteriophage|
|no penetration at 2 psi(13.8 kPa)|
1 In order of increasing protection
2 American Association of Textile Chemists and Colorists (AATCC) 42 Water resistance: impact penetration test determines the ability of a material to resist water penetration under spray impact [AATCC 2000]
3 AATCC 127 Water resistance: hydrostatic pressure test determines the ability of a material to resist water penetration under constant contact with increasing pressure [AATCC 1998]
Personal Protective Equipment
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
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."
YOU ARE SAFE WITH BODYGARD!
Actual Articles & Industrial Information
Articles about industrial technology, our products and our company
Sterile Surgical Gown
Nonwoven at both sides provides cloth like feeling to human body. Microporous film provides breathable but liquid & blood resistance. Conforms to EN13795 - High performance (Critical Area) and is to recommended for surgical gowns and drapes.read blog
BodyGard™ Premium Coverall
High Structural Strength with Excellent Tensile, Tear and Abrasion Resistance Anti-Static (EN1149-1) Helps prevent build-up of Static Electricity , which could present as a major safety risk in certain industries (PetrochemicalIndustry)read blog
BodyGard™ Premium Coverall
Concerned about Wuhan, the Turkish factory started emergency construction for China, and limited medical supplies to Wuhan! High Structural Strength with Excellent Tensile, Tear and Abrasion Resistanceread blog
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