Hygienic Mask Specification

(NewM Korea Co., Ltd.)

1. Scope and Classification

1. Scope(Hygienic Masks)

2. ​Products approved as ‘Quasi-drugs’ in accordance with the regulations for permission/report/examination for quasi-drug products (notified by the Ministry of Food and Drug Safety) by measuring the degree of blocking foreign substances inhaled from the outside

3. Classification(Details) : Hygienic masks

   
   

2. Applied Data and Documents

1. 1. Articles 31 and 42 of the 「Pharmaceutical Affairs Law」

   2. Article 13 (1), 20 (2) and 58 of the 「Regulations on Pharmaceutical Safety」

   3. 「Regulations on the Labeling of Quasi-drugs」

   4. Ministry of Food and Drug Safety Guidelines for Hygienic Mask Standards

   5. Quasi-drug item Permission, Report, and Review Regulations (notified by the Ministry of Food and Drug Safety)

   6. Designation of the Quasi-drug products Scope (notified by the Ministry of Food and Drug Safety)

       

1. Standards
1.1 Grade Standards: Guidelines for hygienic mask standards(Ministry of Food and Drug Safety)
1.2 Size Standards: Guidelines for hygienic mask standards(Ministry of Food and Drug Safety)

2. Packaging and Marking
2.1 Packaging: After packing each hygienic masks Individually, pack it in a small package and then a final box package
2.2 Marking: Label according to the「Regulations on the Labeling of Quasi-drugs」

1. Others
1.1 Country of Origin : Korea

1.2 Expiration Date
1) Delivery within 1 month from the manufacture date
2) Store at room temperature(20℃-23℃) in an enclosed space
3) (Expiration date) 36months from the manufacture date