ZhongKang FDA Letter of Declaration

Zhongkang Protective Equipment Technology Co., Ltd

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

Baiyunhu Road, Baiyun District,Guangzhou,

Guangdong Province, China

zksales@zkhos.com

Letter of Declaration

The Particle filtering half mask, model#ZK601 is manufactured by Zhongkang Protective Equipment Technology Co., Ltd.

The model had passed the NOISH filtering test.   Please kindly see the assessment with test result shown. Link below for info:

https://www.cdc.gov/niosh/npptl/respirators/testing/results/MTT-2020-286.1_International_Zhongkang_ZK601_TestReport_Redacted-508.pdf

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.zkhos.com/h-nd-28.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 : ZK601

Production name : Respiratory protective devices — Filtering half masks

Color: white

Printing: silk printing, Size is 32*23mm (as per available artwork).

Executive standard: GB2626-2006

Packing: no individual packing, 2pcs/foil bag with general packing, 65 x 45 x 52cm, 11.5KGS.

Product pictures:

Wearing instructions

1. Open the mask and pull the ear straps with both hands and make sure the nose clip is above the mask.

2. Cover your chin with a mask.

3. Pull the ear strap behind your ear and adjust the ear strap to feel as comfortable as possible.

4. Adjust the tightness of the mask according to the face shape, press the nose clip to adjust the tightness of the mask with both hands, and check the tightness of the mask by exhaling.

Precautions

1. Checking the mask for any possible damage and deformation before wearing.

2. For bearded wearers, clean the beard before wearing.

3. Take off the mask immediately or replace it in case of breathing difficulty.

4. More information "see manufacturer's information".

Storage conditions and expiration dates:

1. Storage temperature is within the range of -20 ° C + 30 ° C and the relative humidity is not higher than 80% for unopened product.

2. Production license number :(Guangdong)XK02-001-00156

3. Expiration date: 5 years