U.S. Food and Drug Administration - CDRH Mobile
Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website
FDA Home Page | CDRH Home Page | Search | A-Z Index U.S. Food and Drug AdministrationCenter for Devices and Radiological Health Questions?
horizonal rule
Personal Protective Equipment (PPE) and Patient Care
PPE Home
About PPE
PPE and Influenza Outbreaks
Masks and N95 Respirators
Medical Gloves
Surgical Gowns
FDA’s Role in Regulating PPE
Links
SubscribeSubscribe to Email Updates on PPE
Send Feedback

About Personal Protective Equipment (PPE)

On this page:

Personal protective equipment (PPE) and patient care

PPE is any type of specialized clothing, barrier product, or breathing (respiratory) device used to protect workers from serious injuries or illnesses while doing their jobs. Proper use of PPE by workers involved in patient care aids infection control because it helps

  • protect wearers against infection or contamination from blood, body fluids, or respiratory secretions;
  • reduce the chance that healthcare workers will infect or contaminate patients or coworkers; and
  • reduce the chance of transmitting infections from one person to another.
PPE may also be used by workers in health care settings to help protect against certain chemotherapy agents or other hazards surrounding the patient.

Go to Top

When to use PPE in patient care

CDC and OSHA make recommendations or requirements for protecting health care workers from illness or injury that often include recommendations for use of PPE. (CDC's infection control recommendations also are designed to help limit transmission to and among patients.) For more information, see CDC’s Infection Control in Healthcare Settings.

In general, use PPE to cover the face, hands, other exposed skin, and clothing during patient care activities that may cause exposure to body fluids (such as blood, respiratory secretions, vomit, urine or feces), or certain chemotherapy agents.

Go to Top

How PPE intended for patient care is regulated

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 PPE that is marketed for patient care in health care settings (such as surgical masks, gloves and gowns). FDA evaluates the performance of PPE intended for use in patient care before it is marketed. It also makes sure that manufacturers follow good manufacturing practices and address complaints and adverse events associated with their products.

For more information, see FDA’s Role in Regulating PPE.

Go to Top

How to know what types of PPE to use

CDC (the Centers for Disease Control and Prevention), and not FDA, makes recommendations on infection control measures. These may include advice on use of personal protective equipment. For more information about CDC's recommendations for PPE, see CDC's Infection Control Guidelines.

Go to Top

Buying PPE

You do not need a prescription to buy personal protective equipment.

You can buy personal protective equipment from pharmacies, from medical suppliers, or from sources you find on the Internet.

For more information about buying medical products on the Internet, see FDA’s website on Buying Medicines and Medical Products Online

To find lists of all medical devices that have been cleared by FDA for legal commercial distribution, see the following:

Go to Top

Avoid Reusing PPE

Do NOT reuse personal protective equipment. Almost all personal protective equipment used in patient care is disposable and is designed to be used one time for contact with one patient. Dispose of the equipment carefully after each patient use or if the equipment becomes soiled (see Disposing of PPE).

The only type of personal protective equipment that can be reused is a surgical gown that is labeled as washable for multiple use.

Go to Top

Washing and disinfecting PPE

The only type of personal protective equipment that can be washed is a surgical gown that is labeled as washable for multiple use.

There is no proper way to wash or disinfect disposable personal protective equipment. Dispose of the equipment carefully after each patient use or if the equipment becomes soiled (see sections on disposing of PPE below).

Go to Top

Sharing PPE

Do NOT share personal protective equipment. Used equipment will not provide an effective barrier against hazards or infection.

Go to Top

Disposing of contaminated PPE at healthcare and public facilities

The FDA does not regulate the disposal of PPE. The following are general recommendations. Please refer to the EPA's medical waste website, OSHA's bloodborne pathogens and needlestick prevention website, and individual State websites for specific requirements regarding the disposal of contaminated PPE.

PPE that is dripping with blood or body fluids (grossly contaminated) should be placed into a container that is leak-proof and closed. If the outside of the container becomes contaminated, it should be placed into a second similar container. Waste containers must be marked with either a biohazard symbol such as the one shown below, or placed in a colored-coded container such as a red bag.

Biohazard

Lightly soiled PPE, for example PPE with spots of blood or with small amounts of body fluids absorbed into the materials, can be discarded in the regular trash.

Waste containers holding contaminated PPE are considered to be bioharzadous medical waste which needs to be disposed of according to individual state regulations.

There are no additional requirements for disposing of PPE from patients in isolation. Follow the same methods and procedures as for any other medical waste.

Go to Top

Disposing of contaminated PPE at home

When disposing of PPE at home,

  • always wear medical gloves;
  • place used or soiled PPE into a tied plastic bag to prevent dripping;
  • carefully clean waste containers with disinfectant or diluted bleach (1 part bleach to 9 parts water); and
  • wash hands thoroughly with soap and water or alcohol-based hand rub after handling.

Go to Top

Updated May 9, 2006

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH