Posts Tagged ‘#covid-19’
Surgical Mask Guidance
Surgical Mask EUA During the COVID-19 pandemic, the FDA issued Emergency Use Authorizations (EUA) for certain Personal Protective Equipment (PPE), including Surgical Masks. Normally a FDA 510K Premarket Notification is required prior to marketing a mask as a Surgical Mask. This is still a long term requirement. However, due to the issuance of the Umbrella…
Read MoreN95 Mask Sampling Requirements
NIOSH 42 CFR Part 84 provides the standards for the approval of N95 respiratory protective devices. The approval of N95 respiratory protective devices requires that there be a Quality Control Plan in place. Part 84.41 describes the Quality Control Plan. One of the parts of the Quality Control Plan which must be in place in…
Read MoreNIOSH and N95 Respirator Certification Steps
The FDA defines N95 Respirator as a respiratory protective device designed to achieve a very close facial fit and very efficient filtration of airborne particles. The edges of the respirator should be designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset…
Read MoreHand Sanitizer Requirements, COVID-19
The COVID-19 Pandemic has brought the issue of hand sanitizer requirements and their regulation to the national forefront. Because of the public health emergency, the FDA has stated that they do not intend to take action against firms that prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs…
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