Zhongkang FDA聲明書-ZK626

Zhongkang Protective Equipment Technology Co., Ltd

3/F, Building A, No.88, West Dagang Street,

Baiyunhu Road, Baiyun District,Guangzhou,

Guangdong Province, China

Email: zksales@zkhos.com

Letter of Declaration

The Particle filtering half mask, model#ZK626 is manufactured by Zhongkang Protective Equipment Technology Co., Ltd.

The model meets the eligibility criteria 3 in the April 3, 2020 EUA for non-NIOSH approved respirators made in China. The model is added to Appendix A as an authorized respirator

based on above criteria by FDA.

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixa

For formal notification of the Emergency Use Authorization, please kindly check on

http://www.p-share.com/h-nd-33.html#_np=107_759

The respirator is authorized to be distributed to and used in healthcare settings by HCPs when used in accordance with CDC’s recommendations under this EUA, despite the fact that they do not meet certain requirements otherwise required by applicable federal law.

Product Technical Sheet

Style number : ZK626 (FFP2 NR)

Production name : Respiratory protective devices-Particle Filtering Half Mask

Color: white

Printing: silk printing, size is 31*24mm (as per available artwork).

Executive standard: EN 149: 2001 +A1: 2009

Packing: no individual packing, 50pcs/color box, 500pcs per shipping carton.   

Carton size: 667X30X29CM, 5.3KGS.

Product pictures:

Wearing instructions

1 This mask marked “NR” is for single use only.

2 Never substitute, modify, add, or omit parts in the configuration as specified by the manufacture.

3 This mask helps protect against certain particulate contaminants but does not completely eliminate exposure to the risk of contracting disease or infection.

4 It is unlikely that the requirements for leakage will be achieved if facial hair passes under the face seal.

5 Change the mask immediately if breathing becomes difficult or the mask becomes damaged or distorted.

6 Change the mask if a proper face seal cannot be achieved.

FITTING INSTRUCTION

1 Hold the particle half mask in position over the nose and mouth.

2 Pull the upper strap over the head positioning it just above the ears and pull lower strap over the head and fit around the back of the neck.

3 Ensure the nose clip is securely moulded around the nose, resting the ends against the cheek to obtain a good seal.

4 To check for proper fit, cup both hands over the mask and exhale vigorously. If air leaks around the nose, tighten the nose clip, if air leaks around the edge, reposition the headharness for better fit.

5 Repeat adjustments until the mask is sealed properly.

6 If a proper seal cannot be achieved do not enter the contaminated area or it may cause illness.

Storage

1 Store the mask in a sealed container away from contaminated areas when not use.

2 Store the mask in the original packing during transport.

Manufacturer: Zhongkang Protective Equipment Technology (Guangzhou) Co.,Ltd.

Address: 3/F, Building A, No.88, West Dagang Street, Baiyunhu Road, Baiyun District, Guangzhou, Guangdong Province, China