Medical Devices

Personal Protective Equipment (PPE) and Other Government Agencies

All personal protective equipment (PPE) that is intended for use as a medical device must follow FDA’s regulations and meet specific performance standards for protection.  Other government agencies, including those listed below provide guidelines for use of PPE:

The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) assures the safe and healthful working conditions for working men and women by setting and enforcing standards and providing training, outreach, education, and assistance.  OSHA requires employers to provide appropriate PPE for workers who could be exposed to blood or other infectious materials (such as bloodborne pathogens). OSHA may also require employers to provide PPE to protect against other hazards at work. Although OSHA requires the use of specific equipment, it does not regulate the marketing of these devices nor grant claims of disease prevention. OSHA regulations are as follows:

  • 29 CFR 1910.1030 Bloodborne pathogens:
    When there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Personal protective equipment will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.

    For more information on OSHA's bloodborne pathogen standard, see Bloodborne pathogens.

The U.S. Centers for Disease Control and Prevention (CDC) gives recommendations for protecting yourself from infection.

As part of CDC, The National Institute for Occupational Safety and Health (NIOSH) is the U.S. Government agency responsible for the certification and approval of respiratory protective devices for occupational use. It also addresses quality assurance requirements for the manufacturing of respiratory protective equipment. The approach to approval is that anybody can manufacture and sell any type of respiratory protective device, but only those that meet or exceed all of the requirements established in the 42 CFR 84 standards are acknowledged by NIOSH, and only those that have been NIOSH-certified may be marketed as a NIOSH-approved respirator.

Page Last Updated: 06/26/2015
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