Huzhou Ruida Commodity Co.,Ltd

PRODUCT SPECIFICATION
PART I I. . PRODUCT IDENTIFICATION
Code No. SJ05 & SJ06
Product Name :Face Mask
Type EN 14683 : 2014, Type I
Type Earloops Type; Ties On Type
Color :Blue color, Green color, white color, pink color, etc.
Material :2ply PP non-woven + 1ply meltblown fabric
Weight : 3ply: 25 + 25 + 25 G/M2
Key Parameter
1.Bacterial Filtration Efficiency (BFE): ≥ 95%
2.Differential pressure: ≤ 29.4 Pa/cm2
3.Microbial cleanliness: ≤ 30 cfu/g
Applications It's especially used for designed for the medical personal protection.
Type of Product Medical disposable
Sterilization Method: Non-sterile
Storage Instruction: Store in dry, ventilative condition, with ordinary temperature.

PART I II. . QUALITY SYSTEM & STANDARD
Classification Class I (non-sterile)
Standard EN 14683 : 2014
Quality Management Systems & No. : ISO13485 , Q6 080946 0012 Rev. 01
Production Quality Assurance System & No.  Declaration of Conformity  ; AJ-SP200101
CE Conformity Assessment Route :MDD 93/42/EEC Annex VII (Self Declaration)
Certification Body :TUV SUD Product Service GmbH
U.S. FDA Registering No. 3007694982
Listing Number D366504