GIKO 1400 N95 Surgical
MASK-GIKO1400-N95 is a Healthcare Particulate respirator and a surgical mask. As a NIOSH approved N95 mask, it meets the requirements of NIOSH Title 42, Code of Federal Regulations, Part 84 (42 CFR 84).
As a surgical mask, 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.
The mask is a duckbill style constructed from a white non-woven material used in the inner and outer shell with polypropylene melt blown filter media. It has an. elastic rubber headband which keeps its strength even after long time use. The inside of the nosepiece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of plastic coated aluminum.
- NIOSH N95 rated respirator and a surgical mask in one product; NIOSH certification number for N95 respirator: TC-84A-4282 and categorized Medical Device Class II with 510(k) Premarket Notification number: K063334
- Highly efficient filter media which is 95% efficient against 0.3 micron particulate
- Duckbilled, designed to increase comfort and wearability
- Noseclip adjusts easily for greater comfort
- 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 the transfer of microorganisms, body fluid, and particulate material.
- It also meets the CDC Guidelines for TB Exposure Control
Material: Non-woven Fabric
Headband: Elastic Rubber (white)
Inside Nosepiece: Closed Cell Foam
Outside Nosepiece: Plastic-coated Aluminum
Filtering Rate: ≥ 95%
Mask Thickness: 0.038 in
Headband Length: 24 Inches Total Continuous Loop
Facepiece Length: 7.0 Inches
Flammability: Conforms with the requirement as per 16CFR Part1610
NIOSH Approval No: TC-84A-4282
Device Class: Class II with 510(k) Premarket Notification Number K063334
Manufacturer: Shanghai Gangkai Purifying Products Company Limited
Packaging: 10 masks per box OR 30 boxes per carton
Box Details: Weight: 8.5kg/carton, Carton Dimensions: 52.5cm x 48.5cm x 32.5cm
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