Summary Fact Sheet for Disposable Respirators for Use During the Swine Flu Emergency

Printer friendly version of this page   [90 KB]

You have been given a disposable respirator listed below to wear to help reduce your exposure to airborne germs during a public health emergency. Reducing your exposure to airborne germs may reduce your risk of getting infected with flu. You can decide whether or not to use this respirator. If you are given the respirator at work, also talk to your employer.

Whether or not you use a respirator, always follow infection control measures: wash hands, cover coughs and sneezes, stay home if you may be sick. For more on infection control, see "Preventing the Flu: Good Health Habits Can Help Stop Germs". 

What is H1N1 Influenza Virus (Swine Flu)?

Swine flu is a respiratory disease of pigs caused by influenza viruses that causes regular outbreaks in pigs. People do not normally get swine flu, but human infections can and do happen. Swine flu viruses have been reported to spread from person-to-person. In people, symptoms of swine flu are similar to the symptoms of regular human flu. These include fever, cough, sore throat, body aches, headache, chills, and fatigue. Some people have reported diarrhea and vomiting; others have experienced severe illness (for example, pneumonia) and death.

Are there disposable respirators that are cleared by FDA?

FDA has cleared four models of respirators for use by the general public to help reduce wearer exposure to airborne germs during a public health medical emergency, such as a flu pandemic: 3M Respirator Models 8612F and 8670F, and Pasture Pharma Respirator Models F550G and A520G. These respirators that are FDA-cleared for public health emergency use have been tested and shown to achieve a satisfactory fit in most adults. These may be bought without a prescription. These FDA-cleared respirators may not be available in your area. In addition, there are some models of respirators that are cleared by FDA for use in certain workplace settings.

What products does this information apply to?

This fact sheet applies only to the disposable respirators listed in this table. The manufacturer name and model number is printed directly on these products. FDA has authorized emergency use of these respirators by the general public¹ during the current swine flu emergency to help reduce exposure to airborne germs.

What are the benefits of these respirators?

FDA has authorized use of these respirators by the general public during this public health emergency. These respirators are designed to filter out germs that may be present in the air you breathe. They may help reduce your risk of getting sick. They are designed to fit tightly over your mouth and nose, with no gaps. Any gaps will allow air to pass around and reach your nose, mouth, and lungs without being filtered.

These respirators do not eliminate the risk of disease, illness, or death. The effectiveness of these respirators depends on tight fit to your face. Because no respirator provides complete protection against infection, you should always practice other infection control measures such as frequent hand washing, social distancing, and avoiding crowded places. For more information, see "Preventing the Flu: Good Health Habits Can Help Stop Germs".

When should I wear the respirator?

For updated public health recommendations about when and where to use respirators during the swine flu emergency, please refer to H1N1 Flu.

What are the risks of these respirators?

• Individuals with chronic respiratory, cardiac, or other conditions that make it harder to breathe may have difficulty breathing through the respirator, please consult your healthcare provider (doctor) before use.
• Respirators were not designed to fit children. Children's faces may be too small for the respirators to fit properly and provide protection. Children may have difficulty breathing with use of respirators and may not be able to let others know if they are having trouble breathing.
• Some of these respirators may be flammable; use caution around heat sources and do not smoke while wearing the respirator.
• May cause skin irritation; those with latex allergies should avoid Moldex Models 2200 and 2201 and choose another model.
• Spit, blood, or other bodily fluids may get through the following models of respirators: 3M Models 8210, 8000, & 9210; Moldex Models 2200, 2212, and 2201.

How do I use a respirator?

If you are using a respirator at work, talk to your employer about how to wear and use it. When using it at home or elsewhere, follow these instructions.

• Before handling the respirator, wash hands thoroughly with soap and water.
• Inspect the respirator for holes, tears or other damages to surfaces, straps, metal nose strip, and nose foam. If your respirator has been damaged – DO NOT USE IT. Get a new one.
• Anything that comes between the respirator and your face will make the respirator less effective. Do not allow facial hair, hair, jewelry, glasses, or clothing to come between your face and the respirator.
• Put the respirator on correctly:
  1. Prestretch the strap(s) before placing respirator on the face.
  2. If your respirator is folded, unfold it fully.
  3. Cup the respirator in your hand, with the nosepiece at your fingertips, allowing the headbands to hang freely below your hand.
  4. Position the respirator under your chin with the nosepiece up. If there are two straps, pull the top strap over your head, resting it high at the top back of your head. Pull the bottom strap over your head and position it around the neck and below the ears. If there is only 1 strap, it should rest high at the back of your head. Make sure that your mouth and nose are covered by the respirator and that the bottom of the respirator fits underneath the chin. Looking in the mirror may help in positioning the respirator on your face.
  5. Place your fingertips from both hands at the top of the metal nosepiece. For those respirators without a metal nosepiece, no adjustment is possible. Using both hands, mold the nose area to the shape of your nose by pushing inward towards the nose, while moving your fingertips down both sides of the nosepiece. Pinching the nosepiece using one hand may result in improper fit and less effective respirator performance. Use two hands.
  6. Always check your fit when you wear a respirator. There are two steps to assessing the fit. First, place both hands completely over the respirator, then take a quick breath in to check whether the respirator seals tightly to the face. Next, place both hands completely over the respirator and exhale. Be careful not to disturb the position of the respirator. If during either step, air leaks around the nose, readjust the nosepiece as described in step 5. If air leaks at the mask edges, work the straps back along the sides of your head.
  7. If you cannot achieve a proper fit and seal, ask for help from someone else or try a different respirator model. Different models of respirators may fit faces differently.

     For additional information on how to use the respirator, refer to "Emergency Use Authorization of N95 Respirators".

• How do I remove and dispose of my respirator?

Wash your hands prior to handling the respirator. Carefully remove your respirator using the straps. Discard your respirator by carefully placing it in a closed waste container. Wash your hands after handling the used respirator.

Additional information you should know before using these respirators:

• Respirators should be changed when they become wet from spit or mucus, as they may be damaged.
• These respirators are designed for single use. Do not re-use the respirator.
• Never wash or disinfect these respirators.
• Never share these respirators with others.
• If the respirator becomes damaged, soiled, or breathing becomes difficult, replace the respirator.

How can I report adverse events? 

Report adverse events such as injuries to FDA MedWatch at MedWatch or call 1-800-FDA-1088.

How can I learn more?

For additional information, please refer to "Emergency Use Authorization (EUA) of Medical Products and Devices"

Manufacturer contact information: