DirectProtect™ LEVEL 4 Sterile Surgical Gown with Drape, Full Body, Highly Breathable SSMMS Reinforced Fabric, with Closed Back and Knitted Cuffs, AAMI, FDA 510k & CE Tested, ONE SIZE FITS ALL (2XL Unisex) Kishkindha Healthcare
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Kishkindha Healthcare’s DirectProtect™ AAMI Level 4 Sterile Surgical Gowns are made with the newest technology, to maximize comfort and protection. Made from a proprietary SSMMS (spun-bond, spun-bond, melt-blown, melt-blown, spun-bond) outside layer, PE-reinforcement middle layer and SMS inside layer. DirectProtect Surgical gowns are made with the consumer in mind, with the highest breathability available without sacrificing exceptional protection. To keep the wearer more comfortable for longer periods of time, without compromising fluid, viral or bacterial penetration standards. These gowns are waterproof, full length, knitted cuff disposable medical gowns.
- Material: SSMMS with PE-reinforced layer and inside SMS layer
- Color: Blue
- Sizes available: Small, Large, XL, 2XL, 3XL, X-Long XL, X-Long 2XL; Unisex 2XL by default
- Gown sterilized by EtO sterilization process
- Ultrasonic technology to maximize comfort and seam strength
- Comfortable collar with soft spun lace, with Velcro attachment
- Tear-resistant and flame retardant
- Packaging: Individual EtO sterile bags
- All materials are Latex Free, Heavy Metal Free, PVC and DEHP Free.
The manufacturer is FDA, BIS, GMP, ISO and CE certified
What is a Level 4 Surgical Gown
The AAMI classification system specifies the degree of risk that determines which gown level a healthcare professional should choose. Level 4 represents the high-risk category. This gown offers the most protection in situations that require pathogen resistance or where there is suspicion of the presence of non-airborne infectious diseases. AAMI Level 4 gowns can prevent fluid penetration for up to one hour and may also prevent virus penetration for the same duration. Additionally, surgeons and other medical personnel should wear these gowns when operating on patients who pose a bloodborne pathogen risk. According to the Centers for Disease Control and Prevention (CDC) guidelines, medical personnel who treat COVID-19 patients get enough protection from a non-sterile Level 1 or Level 2 gown. While Level 4 gowns can also be worn when working with these patients, they’re typically allocated for use in operating rooms and in very high-risk scenarios.
TESTED for: Level 4 Gown FDA 510K
Spray Impact (Critical Zones) |
AATCC 42 |
Water Resistance |
Hydrostatic Pressure (Critical Zones) |
AATCC 127 |
Water Resistance |
Liquid Barrier Performance |
ANSI/AAMI PB70:2012 Level 4 |
Water Resistance |
Synthetic Blood Penetration |
ASTM F1670 |
Resistance to |
Viral Penetration |
ASTM F1671 |
Resistance to Penetration |
Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
ASTM F1929-15 |
Seal Leakage |
Breaking Strength and Elongation of Textile Fabrics (Grab Test) |
ASTM D5034 – 9 |
Breaking Strength |
Tearing Strength of Fabric by Trapezoid Procedure |
ASTM D5587-15 |
Tearing Strength |
Mass Per Unit Area (Weight) of Fabric |
ASTM D3776 / D3776M-09a |
GSM |
Bursting Strength of Textile Fabrics |
ASTM D3786 / D3776M-13 |
Bursting Strength |
Lint Generation |
ISO 9073-10 |
Particulate |
The standard for the Flammability for Clothing Textiles |
16 CFR 1610 |
Flammability |
ISO L929 MEM Elution Cytotoxicity |
ISO 10993-5:2009 |
Cytotoxicity |
ISO Indirect Primary Skin Irritation Test |
ISO 10993 -10:2010 |
Irritation |
ISO Kligman Maximization Test |
ISO 10993-10:2010 |
Sensitization |
EO Sterilization Residuals |
ISO 109937-7:2008 (R) 2012 |
EO Residuals |
Sterilization of Health Care Products - Microbiological |
ISO 11737-1:2018 |
Bioburden Test |
Tearing Strength of Non-woven Fabrics by the Trapezoid Procedure |
ASTM D5733 |
Tear Resistance |
Seam Strength Coated Fabrics |
ASTM D751-19 |
Seam Strength |
Air Permeability of Textile Fabrics |
ASTM D737-75-18 |
Pressure Differential |
ANS : ASTM Level 1: Ideal for procedures in which there is low risk of fluid exposure (no splashes or sprays expected)
Q. What makes our products unique?
ANS : All our products are researched, developed & certified by FDA approved and have been tested in accordance with ASTM F2100-19 and ISO 10993-510.
Q. Where are these made(origin of the mask)?
ANS : • Made in India.
Q. Are these masks true ASTM level 1?
ANS :Yes, we have been selling Level 1 face masks for about 10 years and our all product have proper certification and Lab tested report.
Q. How Many Layers in Level 1?
ANS :3 Ply.
