What is the FDA?
The Food and Drug Administration (FDA or USFDA) is a federal agency of the U.S. Department of Health and Human Services. The FDA promotes public health through control and supervision of product categories.
What does the FDA regulate?
- Medical Devices
- Electronic Products that give off radiation
- Veterinary Products
- Tobacco Products
Classifications and Types of Face Masks and Respirators
Reduce transfer of germs and contamination. Minimize contamination caused by exhaled microorganisms and contagious droplets. Protect yourself and others by using the right kind of face mask or respirator.
Disposable Face Masks
A face mask, with or without a face shield. Covers the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels.
From anti virus masks to cleanroom masks to surgical procedure medical face masks, Harmony Lab & Safety Supplies is a trusted source for many types of disposable face masks and respirators. Popular variations include reusable face masks and earloop face masks.
Reusable Face Masks
Cotton ear loop face masks that you can wash and use over and over. Sewn-in filter face masks step up your protection. Comfortable, effective, and reusable, washable cloth masks are a popular standard for everyday wear. Form-fitting cloth masks are an economical choice for face protection to prevent contamination.
A face shield is a device used to protect the user’s eyes and face from bodily fluids, liquid splashes, or potentially infectious materials. Generally, a face shield is situated at the crown of the head and is constructed with plastic to cover the user’s eyes and face.
A face mask with a shield is a good solution in situations where you need to add protection to the eyes against liquid splash and other factors in the environment.
The Shift to Shields
Amidst COVID-19, worldwide use of personal protection is shifting from face masks to face shields.
A mask that covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials. The mask meets certain fluid barrier protection standards and Class I or Class II flammability tests.
Ideal for both medical applications and other situations that are prone to splatters or fumes such as painting, superior full-face protection.
Filtering Face-Piece Respirators
Comparatively, a filtering facepiece respirator (FFR) is a device that with these features: disposable half-face-piece, non-powered, and a air-purifying particulate respirator. Intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates. This reusable N95 mask uses replaceable filters with a comfortable and reusable facepiece.
Dust Masks and Respirators are considered essential protective equipment in many industries where excessive dust and air particles can seriously damage workers’ lungs and respiratory system. Wearing a Disposable Respirator is an effective and cost-effective technique to protect against harmful contaminants and pathogens that can cause serious health issues.
A disposable half-mask filtering facepiece respirator (FFR) that covers the user’s airway (nose and mouth) and offers protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181. N95 FFR used in a healthcare setting is regulated by FDA. In addition they are also either a class II device that is exempt from premarket requirements, or a class II cleared device.
A respirator mask is a must-have personal protective equipment in many professions. Wearing a N95 respirator serves as a contamination protection against a number of harmful pathogens and airborne particulates, droplets, and aerosols that can cause serious illness.
An N95 respirator, approved by NIOSH (The National Institute for Occupational Safety and Health) that meets filtration efficiency level per 42 CFR 84.181.
Surgical N95 Respirators
Disposable FFR used in a healthcare setting. Particularly worn by Healthcare Providers (HCP) during procedures to protect both the patient and HCP from the transfer of microorganisms, body fluids, and particulate material. At an N95 filtration efficiency level per 42 CFR 84.181. Surgical N95 respirators are regulated by FDA. Similarly, they are either a class II device that is exempt from premarket notification requirements, or is a class II cleared device.
Your choice of face mask is important. Minimize contamination. Reduce exposure. Find cost-effective and efficient filtration for infection control in health care, and anywhere!
Make sure to get the right kind of face mask or respirator for your needs. Wearing the wrong kind of protection can be like not wearing any at at all. Need help? Get in touch! We’ll be glad to assist in your selection.