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Surgical Face Masks Medical Grade

Heat sealed 3-Layer design

Inner layer: Spun-bond polypropylene
Middle layer: Meltblown polypropylene
Outer layer: Spun-bond polypropylene
Nosepiece: White aluminum strip covered by PP covering
Headband: Urethane elastic fiber or spun-bond polypropylene


510(k) Number: K173062
Level: Medical Surgical
Trade/Device Name: Non Woven Face Mask 
Model: VQN0185W (earloop) 
Dimensions: 175mm×95mm
Ear Loop: 20cm
Regulation Number: 21 CFR 878.4040
Regulation Name: Surgical Apparel
Regulatory Class: Class II
Product Code: FXX


Inner Case Qty: 50 PCS
Master Case Qty: 20 Inners (Total: 1,000 PCS)
40 HQ Container: 1,850 CTNS
Carton Size( cm): 52.5 x 19.8  x 34.5

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  • MediSafe
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  • Address:
  • 351 Spook Rock Rd
    Suffern NY 10901

FDA Registration Number: 3016842614
FDA Owner Operator Number: 10073328
Cage Code: 8NT04