Personal Protective Equipment

Personal protective equipment is any type of specialized clothing, eye shield or facial barrier that is used to protect the wearer from serious injuries or illnesses.

About Personal Protective Equipment (PPE)

Q. How does personal protective equipment help prevent the spread of infection?

A. Personal protective equipment acts as a barrier between infectious materials and your skin, mouth, nose, or eyes (mucous membranes).

The barrier has the potential to block the spread of infection from blood, body fluids, or respiratory secretions.

Q. Will personal protective equipment protect against flu (influenza)?

A. All personal protective equipment cleared by FDA must meet specific performance standards for protection. These standards vary depending on the specific type of equipment. The information that FDA uses for the evaluation and clearance of personal protective equipment does not include performance against a specific influenza virus. Thus neither FDA, nor a manufacturer, knows to what extent PPE will protect you against influenza. Keep in mind that other infection control practices, such as hand-washing, using alcohol-based hand sanitizers, isolating sick patients, and using appropriate coughing etiquette, are also important to minimize your risk of infection.

Q. Should I use personal protective equipment to help protect against infection when caring for a sick person at home?

A. The use of PPE alone will not fully protect you from acquiring an infection. Other infection control practices, such as hand-washing, using alcohol-based hand sanitizers, isolating of patients and using appropriate coughing etiquette, are also important to minimize your risk of infection.

The Centers for Disease Control (CDC), is responsible for making specific recommendations for infection control measures in different circumstances. These recommendations may include the use of PPE as part of a broader set of actions.

Q. Where can I buy personal protective equipment?

A. You do not need a prescription to buy most types of personal protective equipment. You can buy personal protective equipment from pharmacies, from medical suppliers, or from sources you find on the Internet.

Q. Can I reuse personal protective equipment?

A. Most personal protective equipment is designed to be used one time. It is not intended to be used over and over. There are a few exceptions (for example some types of protective eyewear).

It is important to understand that if you are exposed to infectious material while wearing personal protective equipment, your PPE should be considered contaminated. Remove it promptly and dispose of it properly. Improper removal, reuse or improper disposal of contaminated PPE may increase your risk of infection.

Q. Can I wash disposable personal protective equipment?

A. No. You cannot wash disposable personal protective equipment. Washing personal protective equipment changes its protective or barrier properties, and it may no longer be effective.

It is important to understand that if you are exposed to infectious material while wearing personal protective equipment, your PPE should be considered contaminated. Remove it promptly and dispose of it properly. Improper removal, reuse or improper disposal of contaminated PPE may increase your risk of infection.

Q. Can I share personal protective equipment with other users?

A.No. You should not share personal protective equipment. Most PPE is not intended to be used over and over. The protective capabilites of a PPE cannot be assured when it is reused by either yourself or another person. Perhaps more importantly, by sharing, you may inadvertently be exposing another person to infectious material. PPE should be removed promptly after use and disposed of properly. Improper removal, reuse or improper disposal of contaminated PPE may increase your risk of infection.

Masks and N95 Respirators

Facemasks and N95 respirators are devices that may help prevent the spread of germs (viruses and bacteria) from one person to another. They are one part of an infection-control strategy that should also include frequent hand washing and social distancing.

Facemasks and N95 respirators should not be shared. Facemasks and respirators may become contaminated with germs (viruses and bacteria) that can be spread between people.

The following provides basic information about facemasks and N95 respirators.

Facemasks

A facemask is a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. Facemasks may be labeled as surgical, laser, isolation, dental or medical procedure masks. They may come with or without a face shield.

Facemasks are made in different thicknesses and with different ability to protect you from contact with liquids. These properties may also affect how easily you can breathe through the facemask and how well the facemask protects you.

If worn properly, a facemask is meant to help block large-particle droplets, splashes, sprays or splatter that may contain germs (viruses and bacteria) from reaching your mouth and nose. Facemasks may also help reduce exposure of your saliva and respiratory secretions to others.

While a facemask may be effective in blocking splashes and large-particle droplets, a facemask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes or certain medical procedures. Facemasks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the facemask and your face.

Facemasks are not intended to be used more than once. If your mask is damaged or soiled, or if breathing through the mask becomes difficult, you should remove the facemask, discard it safely, and replace it with a new one. To safely discard your mask, place it in a plastic bag and put it in the trash. Wash your hands after handling the used mask.

N95 Respirators for Use by the Public

An N95 respirator is a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. In addition to blocking splashes, sprays and large droplets, the respirator is also designed to prevent the wearer from breathing in very small particles that may be in the air.

To work as expected, an N95 respirator requires a proper fit to your face. Generally, to check for proper fit, you should put on your respirator and adjust the straps so that the respirator fits tight but comfortably to your face. For information on proper fit, refer to the manufacturer’s instructions.

The ‘N95’ designation means that when subjected to careful testing, the respirator blocks at least 95% of very small test particles. If properly fitted, the filtration capabilities of N95 respirators exceed those of face masks. However, even a properly fitted N95 respirator does not completely eliminate the risk of illness or death.

N95 respirators are not designed for children or people with facial hair. Because a proper fit cannot be achieved on children and people with facial hair, the N95 respirator may not provide full protection.

People with chronic respiratory, cardiac, or other medical conditions that make it harder to breathe should check with their healthcare provider before using an N95 respirator because the N95 respirator can require more effort to breathe. Some models have exhalation valves that can make breathing out easier and help reduce heat build-up.

ALL FDA-cleared N95 respirators are labeled as "single use", disposable devices. If your respirator is damaged or soiled, or if breathing becomes difficult, you should remove the respirator, discard it properly, and replace it with a new one. To safely discard your N95 respirator, place it in a plastic bag and put it in the trash. Wash your hands after handling the used respirator.

FDA has cleared the following N95 respirators for use by the general public in public health medical emergencies:

3M™ Particulate Respirator 8670F 3M™ Particulate Respirator 8612F Pasture Tm F550G Respirator Pasture Tm A520G Respirator These devices are labeled "NOT for occupational use.”

This video, intended for the general public, demonstrates how to put on and take off disposable respirators that are to be used in areas affected by the influenza outbreak.

N95 Respirators in Industrial and Healthcare Settings

Most N95 respirators are manufactured for use in construction and other industrial type jobs that expose workers to dust and small particles. These respirators are evaluated for effectiveness by the National Institute for Occupational Safety and Health (NIOSH), which is part of the Centers for Disease Control (CDC). These are labeled "For occupational use.”

N95 respirators cleared by FDA for use in the healthcare setting are called surgical N95 respirators. These devices meet some of the same performance standards as surgical face masks and are also NIOSH certified to meet the N95 respirator performance requirements.

Medical Gloves and Gowns

Medical gloves are disposable gloves used during medical procedures. Medical gloves help prevent contamination between caregivers and patients. Some are designed to prevent contact with certain chemotherapy drugs.

Medical gloves include examination gloves, surgical gloves, and medical gloves for handling chemotherapy agents (chemotherapy gloves). These gloves are regulated by the Food and Drug Administration (FDA). FDA makes sure that manufacturers of these devices meet performance criteria such as leak resistance, tear resistance, etc.

When to use medical gloves

Use medical gloves when your hands or nails may touch someone else’s body fluids (such as blood, respiratory secretions, vomit, urine or feces) or certain hazardous drugs.

What you should know before using medical gloves

• Wash your hands before putting on sterile gloves.
• Make sure your gloves fit properly for you to wear them comfortably during all patient care activities.
• Some people are allergic to the natural rubber latex used in some medical gloves. FDA requires manufacturers to identify on the *package labeling the materials used to make the gloves. If you are allergic to natural rubber latex, you should choose gloves made *from other synthetic materials (such as polyvinyl chloride (PVC), nitirole, or polyurethane).
• Be aware that sharp objects can puncture medical gloves.
• Always change your gloves if they rip or tear.
• After removing gloves, wash your hands thoroughly with soap and water or alcohol-based hand rub.
• Never reuse medical gloves.
• Never wash or disinfect medical gloves.
• Never share medical gloves with other users.

About surgical gowns

Surgical gowns are garments worn during medical procedures. Gowns help prevent contamination between caregivers and patients, and they protect the caregiver's clothing.

You should consider using a surgical gown to cover your trunk, arms, legs, and clothing when you may be splattered by someone else’s body fluids (such as blood, respiratory secretions, vomit, urine or feces).

Surgical gowns, which also include isolation gowns, are regulated by the Food and Drug Administration (FDA). FDA makes sure that manufacturers of these devices meet performance criteria such as penetration resistance and tear resistance.

FDA's Role in Regulating PPE

The Food and Drug Administration (FDA) is the U.S. Government agency that oversees most medical products, foods, and cosmetics.

Within FDA, the Center for Devices and Radiological Health (CDRH) oversees the safety and effectiveness of medical devices and radiation-emitting products.

FDA's role in PPE

PPE that is intended for use in preventing or treating disease is subject to regulation under the device provisions of the Federal Food, Drug, and Cosmetic Act. This includes surgical masks, N95 respirators, medical gloves, and surgical gowns.

Before these devices can be sold in the U.S., FDA evaluates the manufacturer's new product applications (premarket notifications or 510[k]s) to make sure that the new devices are similar to (substantially equivalent to) existing products already on the market. FDA refers to this as clearing the products for market.

Once FDA has cleared the products, it:

• maintains databases of those products and their manufacturers;
• ensures that manufacturers use reliable methods for manufacturing and packaging the products (Good Manufacturing Practices); and
• reviews and analyzes reports of medical device problems.
• If FDA finds ongoing problems with a medical product, it may oversee a manufacturer's recall, recommend changes to the labeling or instructions, or suggest corrective actions.

Roles of other Government agencies

OSHA (the U.S. Department of Labor's Occupational Safety and Health Administration) requires employers to provide appropriate PPE for workers who could be exposed to blood or other infectious materials (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.

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.

The National Institute for Occupational Safety and Health (NIOSH) has established certification requirements for various respiratory PPE, which are found at 42 CFR part 84. NIOSH tests products for compliance with these regulations and issues a certification for products that comply. NIOSH certification evaluates the performance of respiratory protection equipment in functional terms and not in terms of claims for use in preventing disease. NIOSH certification is not required for a non-medical respirator to be sold. However, employers subject to OSHA and the Mine Safety and Health Administration (MSHA) regulation may be required to provide NIOSH-certified respiratory protection equipment to satisfy their OSHA and MSHA requirements.

External Links

• For more information about CDC’s recommendations for controlling the spread of the flu, see What You Should Know about the Flu.

• For more information about buying medical products on the Internet, see FDA’s website on

• Protecting Yourself.

• For more information on the proper use and removal of masks and respirators, or to learn more about these and other issues relating to pandemic influenza, visit http://www.pandemicflu.gov.

• For more information on how FDA regulates PPE and other medical devices, see FDA Device Advice: Overview of Regulations.

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

• CDC (the U.S. Centers for Disease Control and Prevention) gives recommendations for protecting yourself from infection, including swine flu. See Swine Influenza (Flu) (US Centers for Disease Control and Prevention) http://www.cdc.gov/swineflu