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    Test Report: Applicant Address

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    Antonio Aquino Osorio
    The test report summarizes the results of testing a particulate respirator KN95 face mask submitted by Homar Bio-Technology (Guangzhou) Holding Co., Ltd. Testing showed acrylonitrile content of 15ppm and nitrogen content of 18.1%, both within specified limits. Extractives testing in various simulants also showed results under the limit of 0.01 mg/in2. The particulate respirator was approved based on compliance with FDA regulations for polypropylene articles intended for repeated use.

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    Test Report: Applicant Address

    Uploaded by

    Antonio Aquino Osorio
    133 views4 pages
    The test report summarizes the results of testing a particulate respirator KN95 face mask submitted by Homar Bio-Technology (Guangzhou) Holding Co., Ltd. Testing showed acrylonitrile content of 15ppm and nitrogen content of 18.1%, both within specified limits. Extractives testing in various simulants also showed results under the limit of 0.01 mg/in2. The particulate respirator was approved based on compliance with FDA regulations for polypropylene articles intended for repeated use.

    Original Description:

    kn95

    Original Title

    FDA test report-KN95-Homar(2020-03-12)

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    The test report summarizes the results of testing a particulate respirator KN95 face mask submitted by Homar Bio-Technology (Guangzhou) Holding Co., Ltd. Testing showed acrylonitrile content of 15ppm and nitrogen content of 18.1%, both within specified limits. Extractives testing in various simulants also showed results under the limit of 0.01 mg/in2. The particulate respirator was approved based on compliance with FDA regulations for polypropylene articles intended for repeated use.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    133 views4 pages

    Test Report: Applicant Address

    Uploaded by

    Antonio Aquino Osorio
    The test report summarizes the results of testing a particulate respirator KN95 face mask submitted by Homar Bio-Technology (Guangzhou) Holding Co., Ltd. Testing showed acrylonitrile content of 15ppm and nitrogen content of 18.1%, both within specified limits. Extractives testing in various simulants also showed results under the limit of 0.01 mg/in2. The particulate respirator was approved based on compliance with FDA regulations for polypropylene articles intended for repeated use.

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    You are on page 1of 4

    Test Report

    Report No: BTK20200212002FDA Date: Mar. 13, 2020 Page 1 of 4

    Applicant ： Homar Bio-Technology (Guangzhou) Holding Co., Ltd.

    Address ： No.28 Qiyuan Road, Huashan Town, Huadu District, Guangzhou 510880,
    Guangdong, P.R. China

    The following sample(s) was /were submitted and identified on behalf of the clients as：

    Sample Name ： Particulate Respirator KN95 Face Mask

    Trade Name ： N/A

    Sample Model ： KN95-PTMYKZ-01

    Sample Received Date ： 2020.02.12

    Testing Period ： 2020.02.12 to 2020.03.13

    Test Requested ： As specified by client, for compliance with Food and Drug
    Administration Regulations for determining the amount of total
    extractives from polypropylene articles intended for repeated use.

    General test result ： Approved

    Test Method ： Please refer to next page(s).

    Test Result ： Please refer to next page(s).

    Signed for and on behalf of

    Dexter Chan/ Approved Signatory

    This report shall not be altered,increased or deleted.The results shown in this test report refer only to the sample(s) tested. Without written approval of BTK, this test
    report shall not be copied except in full and published as advertisement. BTK Physical & Chemical Lab.

    Guangzhou Bestek Testing Services Co., Ltd Website: http://www.btktest.com.cn

    .
    Test Report
    Report No: BTK20200212002FDA Date: Mar. 13, 2020 Page 2 of 4

    Sample Description：

    No. Description Name

    Particulate Respirator KN95 Face


    1 Textile
    Mask

    Test Result: No.1


    Test Method: As specified in FDA 21 CFR 177.1040
    Test item Simulant Used Result Limit

    Acrylonitrile Distilled Water 15ppm 80ppm

    Test item Simulant Used Result Limit

    Nitrogen content Distilled Water 18.1% 17.4%-19%

    Simulant Used Test Condition Total nonvolatile extractives Limit

    deionized water 2 hours at reflux temperature <0.01 mg/in2 0.01 mg/in2

    8 % alcohol 2 hours at reflux temperature <0.01 mg/in2 0.01 mg/in2

    50 % alcohol 2 hours at reflux temperature <0.01 mg/in2 0.01 mg/in2

    n-heptane 2 hours at reflux temperature <0.01 mg/in2 0.01 mg/in2

    This report shall not be altered,increased or deleted.The results shown in this test report refer only to the sample(s) tested. Without written approval of BTK, this test
    report shall not be copied except in full and published as advertisement. BTK Physical & Chemical Lab.

    Guangzhou Bestek Testing Services Co., Ltd Website: http://www.btktest.com.cn

    .
    Test Report
    Report No: BTK20200212002FDA Date: Mar. 13, 2020 Page 3 of 4

    Sample Photos:

    General view for KN95-PTMYKZ-01

    General view for KN95-PTMYKZ-01

    This report shall not be altered,increased or deleted.The results shown in this test report refer only to the sample(s) tested. Without written approval of BTK, this test
    report shall not be copied except in full and published as advertisement. BTK Physical & Chemical Lab.

    Guangzhou Bestek Testing Services Co., Ltd Website: http://www.btktest.com.cn

    .
    Test Report
    Report No: BTK20200212002FDA Date: Mar. 13, 2020 Page 4 of 4

    General view for KN95-PTMYKZ-01

    General view for KN95-PTMYKZ-01

    *** End of Report ***


    This report shall not be altered,increased or deleted.The results shown in this test report refer only to the sample(s) tested. Without written approval of BTK, this test
    report shall not be copied except in full and published as advertisement. BTK Physical & Chemical Lab.

    Guangzhou Bestek Testing Services Co., Ltd Website: http://www.btktest.com.cn

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