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N95 Respirators and Surgical Masks (Face Masks) FDA

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Face Mask Regulations and Standards in the US An Overview

Surgical Masks and Respirators 21 CFR (FDA) Surgical masks sold in the US are regulated under 21 CFR Section 878.4040 Surgical apparel by the FDA. According to the definition provided by the FDA, surgical masks are intended to protect both the wearer and the patient from microorganisms, body fluids, and others.

3 Tips for Choosing the Right Face Mask Halyard Health

A Surgical N95 Respirator is a NIOSH-approved N95 Respirator that has been cleared by the FDA for use as a surgical mask. Unlike other masks, N95 respirators must be fit-tested for each individual to ensure proper protection.

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Guide to Face Mask Selection and Use

Filtration Efficiency BFE ≥ 98% PFE ≥ 98% @ 0.1 micron Breathability - Delta P < 5.0 mm H2O/cm2 Flame Spread Class 1 MAXIMUM FILTRATION NIOSH Approved N95 Particulate Respirator High Fluid Resistance 160 mmHg Filtration Efficiency Meets CE 0121 – In reference to EN 149 2001 FFP2 NR.PFE = 99.9% @ 0.1 micron

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This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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Manufacturing Facilities ISO 13485 / ISO 9001:2015. Indication for Use Pasture 60S Surgical Mask is a US FDA approved surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. NOTE 1

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CE Certification - Class I Medical Device CE Marking

But majority of the manufactures still depend on a third party Certification to get a reputed CE Certificate. [b] Class I Sterile Devices. Class 1 Sterile Device CE Marking process can be completed only by complying with MDD requirements and Harmonized Standards, followed by submitting Technical File to Notified Body and Site Audit.

Surgical Disposable Supplies Manufacturer - SMS

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