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

A: “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 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.”

At Total Papers, the safety and well-being of our customers is our top priority. We work closely with manufacturers who are licensed to produce and supply PPE products. 

Q: Will personal protective equipment protect against a specific disease?

A: 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.”

At Total Papers, we, and neither the manufacturer, can safely protect your health against contracting COVID-19. However, PPE is meant to minimize exposure and hazard that can cause serious illness, such as COVID-19. 

Q: Can I reuse PPE, specifically 3-ply masks and vinyl gloves?

A: “In general, most PPE is designed to be used only one time and by one person prior to disposal. 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.” 

At Total Papers, we do not recommend re-using the 3-ply masks or vinyl gloves for your own safety and well-being. As the FDA has cited, PPE is designed to be used once by one person and then disposed of properly. 

Q: Does Total Papers accept any returns or refunds for defective PPE?

A: Total Papers is not liable for any defect or deficiency in any PPE products sold to the consumer. Please refer to the manufacturer located in the product manual or product packaging to inquire about any concerns or issues with PPE. 

NOTE: Personal protective equipment, commonly referred to as "PPE," is equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses. As long as you have enough supply on hand to protect all employees, your PPE will contribute to a safer work environment. Wearing PPE does not restrict you from contracting COVID-19, rather it is a safe practice put into place to eliminate exposure to a specific virus or bacteria.

Source: FDA