DirectProtect™ LEVEL 3 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
A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter. Because of the controlled nature of surgical procedures, critical zones of protection have been described by national standards. As referenced in Figure 1: the critical zones include the front of the body from the top of the shoulders to the knees and the arms from the wrist cuff to above the elbow. Surgical gowns can be used for any risk level (Levels 1-4). All surgical gowns must be labelled as a surgical gown
- Used in MODERATE risk situations
- Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2
- Two tests are conducted to test barrier protection performance: Water impacting the surface of the gown material.
- Pressurizing the material
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.