1. table of contents (page 1) 4. european test & technical
TRANSCRIPT
1. Table of Contents (Page 1)
2. Basic Information (Page 2)
3. Packaging & Pictures (Page 3-4)
4. European Test & Technical Documentation Review Report
(Page 5-12)
5. Registration on DIMDI & Declaration of Conformity (Page
13-14)
6. ISO Production Standards Report (Page 15-22)
7. Manufacturer Qualification Certificate & Export License
(Page 23-25)
P1
Disposable Medical Face Mask Inherent-Type IIR Earloop
Brand: Inherent
Type No.: YX011 (Earloop)
Performance standard: EN 14683:2019 + AC:2019(E) Annex B
/C/D & YY/T 0969-2013, tested by TÜV Rheiland & Intertek
Production standards: ISO 10933-10:2010 & ISO 10993-
5:2009, tested by CCIC
Classifications: Type IIR Earloop (Non-
Sterile), No latex ingredients
Material: Two-layer PP Nonwoven fabric and One-
layer BFE95 Meltblown fabric (3 layers)
Mask specifications: Universal, 17,50 x 9,50 cm
Earloop design: Breathable and comfortable for prolonged w
earing
Expiration date: 2 years from the date of manufacture
P2
Packing specifications: 10 pcs. / PE bag, 50 pcs. /
box, 40 boxes 2000 pcs. / carton, 16 cartons / euro pallet
Carton measurements: 51.5 x 39 x 35.5 cm, G.W. 9.1 KGS.
Stock available: Rotterdam The Netherlands, Frankfurt a/m
Germany and Madrid Spain
P3