Ministry of food and drug safety

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Diagnostics Devices, MFDS-regulated Mask Information

The types of MFDS-regulated Masks
  • Registration Date 2020-07-13
  • Hit 8251
[unofficial translation]

MFDS-regulated masks are categorized into filtering respirators, surgical masks and anti-droplet masks under the MFDS Notice No.2020-48(Revised on 29 May 2020).

1) “Filtering Respirators” means products used to protect the respiratory system against an infectious agent or toxic substances such as yellow dust and fine dust.
→ When approved, filtering respirators are classified as KF80, KF94 or KF99 masks according to the MFDS’s standards and specifications.
* “KF” is an acronym for Korea Filter.
** Please refer to the attached file for the comparison of performance specifications between filtering respirators and EU filtering facepiece respirators.

2) “Surgical Masks” refers to products used to prevent infection during medical care, treatment, or surgery.

3) “Anti-Droplet Masks” means products which is light, more air-permeable, and effective in preventing droplet transmission in daily life. They are a type of surgical masks for the public. They are also referred to as “Surgical Mask for Anti-Droplet.”
→ Upon approval, they are marked as KF-AD.
* “KF-AD” signifies Korea Filter for Anti-Droplet masks.
Attached File Attach all down
  • 0129 Comparison of specifications.pdf Download

Division 국제협력담당관

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