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Surgical Masks Premarket Notification 510 k

This guidance supersedes Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification 510 k Submissions for Surgical Mask issued January 16, 1998.

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Medical Face Masks Shenzhen Yiheng Technology Co., Ltd

China Medical Face Masks catalog of Disposable FDA 510K/En14683 Nonwoven Doctor Medical Face Mask, 3 Ply Non Woven Disposable Surgical Medical Face Mask with Earloop provided by China manufacturer Shenzhen Yiheng Technology Co., Ltd., page1.

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Masks and N95 Respirators FDA

Facemasks and N95 respirators are examples of personal protective equipment that are used to protect the wearer from liquid and airborne particles contaminating the face. They are one part of an

Masks and N95 Respirators FDA

Facemasks and N95 respirators are examples of personal protective equipment that are used to protect the wearer from liquid and airborne particles contaminating the face. They are one part of an

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FDA Eases Regulations on Face Masks and Respirators

On March 25, 2020, the Food and Drug Administration FDA issued a detail rich guidance about its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease COVID 19 Public Health Emergency with the stated intent to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators including N95

Section 2510 k SummaryJUlL

Device nameGreenCross Surgical Mask The GreenCross Surgical Masks are indicated as a protective nose and mouth covering for health care workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situations where there is a risk of microorganism, body fluid, and particulate aerosol transfer.

Guide to Face Mask Selection and Use

Meets EN14683 Rating Type II Standard. LOW PERFORMANCE Surgical Molded Utility Mask Physical Barrier Only No LEVEL Performance Level ** Filtration Efficiency N/A ** Unless mask manufacturer certifies that the mask meets LEVEL performance Level 1 Ideal as a comfortable substitute for earloop face masks,

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