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Level 2, Flat-Folded NordiwellTM Surgical Mask is 510K cleared

Level 2, Flat-Folded NordiwellTM Surgical Mask is 510K cleared
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  • Time of issue:2021-07-09 12:44
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(Summary description)

Level 2, Flat-Folded NordiwellTM Surgical Mask is 510K cleared
Top

(Summary description)

  • Categories:Company News
  • Author:
  • Origin:
  • Time of issue:2021-07-09 12:44
  • Views:
Information

Level 2, Flat-Folded NordiwellTM Surgical Mask is 510K cleared
 
June 29, 2021, our K210445 level 2 flat-folded NordiwellTM medical face mask got the FDA 510(K) clearance, it is the 3rd time that the surgical mask manufactured by Combat was cleared by FDA. Now, we have three 510K cleared surgical masks, K202615 for level 3 flat-pleat style with ear-loop, K200181 for level 3 flat-pleat style with tie strings, and K210445 for level 2 flat-folded ear-loop and head-wear style masks, respectively.
 
The K210445 surgical mask has been rigorously tested by industry-leading, global laboratory, Nelson lab for ASTM F2100 level 2 and SGS for EN14683 Type IIR, and it can provided with great that or equal with 98% BFE and PFE protection, and at a minimum 120mmHg (16.0 kPa) Synthetic Blood Penetration Resistance. Furthermore, it has also been approved by CE MDR and Health Canada MDEL. The NordiwellTM face masks with innovative designs are manufactured with premium materials to provide reliable protection, as well as exceptional breathability and comfort, even for those with sensitive skin or who feel claustrophobic in ordinary masks. 
 
Until now, Combat can provide with a full range of medical/surgical masks complied with EN14683 Type I, Type II, Type IIR, ASTM F2100 level1 level 2 and level 3, and particulate respirators complied with EN149 FFP2, FFP3 and GB2626 KN95. Masks also could be customized and OEM.
 
Inventory in U.S. Warehouse!!!
Advantages: No need to worry about customs clearance.
 
Looking forward to cooperate with you!

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