Kranti’s PPEs are approved by DRDO and SETRA.

Institute of Nuclear Medicine & Allied Sciences (INMAS), Delhi has been authorized for laboratory testing of Personal Protective Equipment (PPE) Body Coverall samples for COVID-19, submitted by prospective manufacturers in India. A laboratory test Synthetic Blood Penetration Resistance Test is conducted and a Test Report is issued for the same by INMAS.

Globally, to help ensure medical devices, including PPE, are safe and effective, the FDA has established Quality Systems Regulations and Good Manufacturing Practices. Manufacturers are expected to use these regulations and practices to maintain consistent product quality and to guide performance testing to make sure that their products conform to recognized consensus standards.  For PPE, these standards may include for fluid resistance, leak protection, filtering capacity, or resistance to tears and snags.  When these regulations and practices are followed, they provide reasonable assurance that the device is safe and effective.

FDA has also issued device-specific guidance for some products so that manufacturers understand the Agency’s expectations.