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File Size: 1MB

Bacterial & Viral Filtration Efficiency Tests | Nelson Labs

Bacterial Filtration Efficiency

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‘KF’ stands for ‘Korean Filter’, and masks are rated by the Korea Food & Drug Administration (KFDA) according to their abilities to their barrage of filtration. KF 94 means the mask blocks more than 94% of the average particle size of 0.4 microns, while KF 99 means the mask blocks more than 99% of the average particle size of 0.4 microns.

Surgical Masks - Premarket Notification [510(k)] Submissions

This guidance supersedes “Draft Guidance for Industry and FDA Reviewers on the Content and Format of Premarket Notification [510(k)] Submissions for Surgical Mask” issued January 16, 1998.

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• Product Composition: nonwovens filter cloth, nose clip and mask belt. • Scope of application: this is a disposable product, suitable for healthcare protection in the general medical and public environment without the risk of body fluid and splashing.

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