Fiscal Year 2020
CERTIFICATE OF FDA REGISTRATION This certifies that:
ENPING JIAXIN DAILY NECESSITIES CO.,LTD. C5,Zone 1, Jiangmen Industrial Transfer, Enping Guangdong, 529400, CHINA has completed the FDA Establishment Registration and Device Listing with the US Food & Drug Administration, through
Owner/Operator Number: 10069275 Device Listing#:See annex YCY will confirm that such registration remains effective upon request and presentation of this certificate until the endof the calendar year stated above, unless said registration is terminated after issuance of this certificate. YCY makes no other representations or warranties, nor does this certificate make any representations or warranties to any personor entity other than the named certificate holder, for whose sole benefit it is issued. This certificate does not denoteendorsement or approval of the certificate-holder’s device or establishment by the U.S. Food and Drug Administration.YCY assumes no liability to any person or entity in connection with the foregoing. Pursuant to 21 CFR 807.39, “Registration of a device establishment or assignment of a registration number does notin any way denote approval of the establishment or its products. Any representation that creates an impression ofofficial approval because of registration or possession of a registration number is misleading and constitutesmisbranding.” The U.S. Food and Drug Administration does not issue a certificate of registration, nor does the U.S.Food and Drug Administration recognize a certificate of registration, YCY is not affiliated with the U.S. Food and Drug Administration.
Issued Date: 16 Apr 2020 Expiration Date: 31 December 2020
Fiscal Year 2020
CERTIFICATE OF FDA REGISTRATION
Annex to Device Listing# for Owner/Operator Number:10069275
Proprietary Name
Product Codes
Device Class
Listing Number
Establishment Operations
KN95 Protective mask
MSH
2
D390254
Manufacturer, Foreign Exporter
END OF THE ANNEX
Issued Date: 16 Apr 2020 Expiration Date: 31 December 2020
Certificate – Cертификат – 證明書 – Certificat – 증명서 – شهادة
Form QAT_10-M04, version 00, effective since March 6th, 2020
Certificate of Compliance No. 4N200331G.EJD0D24
Certificate’s Holder:
Certification ECM Mark:
Enping Jiaxin Daily Necessities Co.,Ltd. Plant 1&Plant 3,C5, District 1, Enping Park, Jiangmen Industrial Transfer Zone, Guangdong province, China
European Conformity
Type Approved
Product:
KN95 Face Mask
Model(s): Verification to:
KN95 Standard: EN 149:2001+A1:2009 related to CE Directive(s): R 2016/425 (Personal Protective Equipment)
Remark: This document has been issued on a voluntary basis and upon request of the manufacturer. It is our opinion that the technical documentation received from the manufacturer is satisfactory for the requirements of the ECM Certification Mark. The conformity mark above can be affixed on the products accordingly to the ECM regulation about its release and its use. Additional information and clarification about the Marking: The manufacturer is responsible for the CE Marking process, and if necessary, must refer to a Notified Body. This document has been issued on the basis of the regulation on ECM Voluntary Mark for the certification of products. RG01_ECM rev.3 available at: www.entecerma.it
Issuance date: 31 March 2020 Expiry date: 30 March 2025 Reviewer Technical expert Amanda Payne
Approver ECM Service Director Luca Bedonni
Ente Certificazione Macchine Srl Via Ca’ Bella, 243 – Loc. Castello di Serravalle – 40053 Valsamoggia (BO) - ITALY +39 051 6705141 +39 051 6705156 info@entecerma.it www.entecerma.it
TEST REPORT
扫码下载报告
VERIFICATION WEBSITE: www.gttc.net.cn VERIFICATION CODE：FMQK-6689-04
No:200076460
ISSUE DATE:2020-04-25
APPLICANT: ENPING JIAXIN DAILY NECESSITIES CO., LTD. ADDRESS: C5, ZONE 1, JIANGMEN INDUSTRIAL TRANSFER ZONE, ENPING CITY, GUANGDONG PROVINCE,CHINA INFORMATION CONFIRMED BY APPLICANT: KN95 PROTECTIVE MASK QUANTITY: THIRTY FOUR PIECES -----------------------------DATE RECEIVED/DATE TEST STARTED: 2020-04-14
CONCLUSION: FILTRATION EFFICIENCY TO NaCl PARTICULATE MATTER INSPIRATORY RESISTANCE EXPIRATORY RESISTANCE FLAMMABILITY HEAD BAND
M M M M M
NOTE：“M”-MEET THE STANDARD'S REQUIREMENT “F”-FAIL TO MEET THE STANDARD'S REQUIREMENT “---”-NO COMMENT REMARK: THIS REPORT IS THE ENGLISH TRANSLATION VERSION OF THE REPORT 200076459. ALL THE TESTED ITEMS ARE TESTED UNDER THE STANDARD CONDITION (EXCEPT FOR INDICATION). COPIES OF THE REPORT ARE VALID ONLY RE-STAMPED. THE EXPERIMENT WAS CARRIED OUT AT No.1, ZHUJIANG ROAD, PANYU DISTRICT, GUANGZHOU, GUANGDONG, P.R.CHINA.
APPROVED BY: Nan Ma ENGINEER
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TEST REPORT No:200076460
PAGE 2 OF 4
TEST REPORT No:200076460 FILTRATION EFFICIENCY TO NaCl PARTICULATE MATTER (GB 2626-2006 6.3,AIR FLOW:85L/min,AEROSOL:NaCl,AEROSOL CONCENTRATION:15mg/, TEMP:23.1℃,RH:36.4%) REQUIREMENT FILTRATION EFFICIENCY(%): FILTRATION EFFICIENCY(%): UNTREATED SAMPLE ≥95.0 1# 99.585 (KN95) 2# 99.610 (GB 2626-2006) 3# 99.578 4# 99.672 5# 99.651 6# 99.490 7# 99.595 8# 99.688 9# 99.615 10# 99.742 CONDITIONING TREATED 1# 99.514 2# 99.340 3# 99.542 4# 99.180 5# 99.475 INSPIRATORY RESISTANCE(Pa) (GB 2626-2006 6.5, HEAD SIZE: MEDIUM) REQUIREMENT UNTREATED SAMPLE: ≤350 1# 104.3 (GB 2626-2006) 2# 99.2 PRETREATMENT SAMPLE: 1# 87.9 2# 85.2 EXPIRATORY RESISTANCE(Pa) (GB 2626-2006 6.6, HEAD SIZE: MEDIUM) REQUIREMENT UNTREATED SAMPLE: ≤250 1# 87.2 (GB 2626-2006) 2# 85.3 PRETREATMENT SAMPLE: 1# 56.8 2# 54.7 FLAMMABILITY(s) (GB 2626-2006 6.15) REQUIREMENT AFTERFLAME TIME AFTERFLAME TIME UNTREATED SAMPLE ≤5 1# 0.0 (GB 2626-2006) 2# 0.0 CONDITIONING TREATED 3# 0.0 4# 0.0
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TEST REPORT No:200076460 HEAD BAND
(GB 2626-2006 6.11) UNTREATED SAMPLE: 1# PASS CONDITIONING TREATED: 1# PASS
REQUIREMENT EACH HEAD BAND, BUCKLE AND OTHER ADJUST PARTS OF MASK SHOULD NOT SLIP OR BREAK UNDER 10N TENSION FOR 10S. (GB 2626-2006)
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