You have questions? We have the answers!

* Information sourced from both CDC and FDA *

Can I reuse PPE?

   In general, most PPE is designed to be used only one time and by one person prior to disposal. There are a few exceptions, for example some types of elastomeric respirator masks and protective eyewear such as goggles may be reused if the user follows decontamination methods in the product labeling.

   If PPE is exposed to infectious materials during use (e.g., body fluids from an infected person) the PPE is considered contaminated and the wearer should remove it promptly, using proper removal and disposal procedures. Please be aware that even if a PPE successfully protects you while it is being worn, improper removal and disposal of contaminated PPEs can expose the wearer and other people to infectious agents.   

How do manufacturers ensure personal protective equipment (PPE) is safe and effective?

   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.  Search for FDA Guidance Documents

Will personal protective equipment protect against a specific disease?

   PPE are designed to create a non-disease specific barrier to penetration of substances, solid, liquid, or airborne particles.  In general, neither FDA nor the manufacturer can provide assurances that PPE will protect you against a specific disease.  The data that FDA uses for the evaluation and clearance of PPE rarely includes performance evaluation or testing against specific viruses, such as Ebola or flu.  If performance data has met FDA requirements and demonstrate protection against a specific disease, the product labeling will state the claim for protection against a specific virus or bacteria.

 When there is an outbreak that affects the broad population, The Centers for Disease Control and Prevention (CDC), is responsible for making specific recommendations for infection control measures in different circumstances and settings.

What type of glove is recommended to care for COVID-19 patient?

Non-sterile disposable patient examination gloves, which are used for routine patient care in healthcare settings, are appropriate for the care of patients with suspected or confirmed COVID-19.

What is the difference between N95 and KN95 Masks? 

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