N95 RESPIRATOR & SURGICAL MASK, NIOSH APPROVED & CLASS II DEVICE

N95 RESPIRATOR & SURGICAL MASK, NIOSH APPROVED & CLASS II DEVICE

 

 

GIKO 1400:

N95 Respirator, NIOSH Approval Number TC-84A-4282

Surgical Mask, Device Class II, 501(k) Number K063334

 

 

  • PRODUCT INFORMATION

     

     

    GIKO 1400 is a Healthcare particulate respirator and surgical mask. It has a duckbill style and constructed with an MBPP (Meltblown Polypropylene) middle layer between layers of inner and outer non-woven material. 

     

    GIKO 1400 is NIOSH approved with approval number TC-84A-4282. It is an N95 respirator that meets the requirements of NIOSH Title 42, Code of Federal Regulations, Part 84 (NIOSH 42 CFR 84). It is compatible to use as protection against various type of dust and non-oily substances generated in construction, mining, foundry, wood, cotton, electronics, pharmaceutical and others where concentration values of filtered particles do not exceed occupational exposure limit range. 

     

    GIKO 1400 is classified as Class II Medical Device under Regulation 21 CFR 878.4040. It is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids and particulate material. This respirator already has a 510(k) Premarket Notification, number K063334.

     

     

     

     

  • PRODUCT FEATURES

     

     

    NIOSH N95 rated respirator and a surgical mask in one product

     

    Has a duckbill style with 3-layers of construction of material: Inner and Outer layers of non-woven white material and a middle layer of Meltblown Polypropylene (MBPP) filter media

     

    Comes with a white, elastic rubber headband and a closed cell foam inside nosepiece and a plastic coated aluminum outside nosepiece

     

    NIOSH certification number for N95 respirator: TC-84A-4282 and 510(k) Premarket Notification number: K063334

     

     

  • ORDER INFORMATION

     

     

    Packaging: 

    1 pc/bag,  10bags/box, 30 boxes/case

    8.5 kg/case

    53cm x 49cm x 33cm

     

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