TH2210 Disposable KN95/N95 Particulate Respirator Face Mask Meets FDA Standard：KN95/ N95/GB2626-2006
Brand：TAYHAMN Model Number：TH2210 Mask Material：Non-woven Function: AntiParticulate，Anti-fog PM2.5 ，Anti-dust， Meets FDA Standard：KN95/ N95/GB2626-2006 Color: White Type: Ear Hanging, Foldable (Head-mounted
)
Certificate of FDA Registration (Certificate No.:fda20200327002) This certifies that Applicant
GUANGZHOU TAYHAMN SAFETY EQUIPMENT MANUFACTURING CO., LTD Yonghe Industrial Park, no.1, North Xinsha avenue, Shapu, Xintang town, Zengcheng district, Guangzhou, Guangdong
Manufacturer GUANGZHOU TAYHAMN SAFETY EQUIPMENT MANUFACTURING CO., LTD Yonghe Industrial Park, no.1, North Xinsha avenue, Shapu, Xintang town, Zengcheng district, Guangzhou, Guangdong
Product Name
N95 Protective Mask （TH2210,TH2210V,TH6210C, TH6210VC, TH1060,TH1080） Get the FDA Registration
Registration Number: AwaitingAssignment
Owner Number: 10064571
Registration Status: Valid
Signer: Wallace Xu Certification Manager Date of Issue: 2020-03-27
Email for certificate query:[email protected] ZUOCE CERTIFICATION & TESTING CENTER Room 809,Bulding 5,No.256 Lin Xia Road, Shanghai,China
Documentation
Review Report
valuation
E No. 3O180206.YQP0Q66 Yangzhou QinKang Protective Equipments Co., Ltd. Holder : Wayao Community, Zhuxi St, Hanjiang District, Yangzhou, China
Review of the Technical Documentation in
Rapport d' Rapport regards of the requirements of the Medical
Review goal : Devices Directive 93/42/EEC Annex VII
Non-Woven Product: Protection Gown, Isolation Gown, Coverall, Kimono, Bedsheet, Pillow Case, Face Mask, Shoe Cover, Oversleeve, Under Pad, Round
Caps, Clip Caps, Glove, Beard Cover, Pants, Bra, 보고서
Shopping Bag, Slipper, Apron, Latex/Nitrile/Vinyle Product : Glove, Paper Mask, Non-Slip Socks, Eye mask
Plastic Product: Shoe Cover, Oversleeve, Visitor
검 Gown, Glove, Apron, Boot Cover, Raincoat, Bathing
Caps
(see the following annex I) Model(s) : Class I Classification : (accordingl o he Man fac rer declara ion)
The output of the Review of the Technical File
审查报告 identified with the no. CE/MDD-2018-A0 Review output : dated 2018-02-01is that no Not-Conformity in regards to the requirements of Directive 93/42/EEC Annex VII has been detected
Date of issue 06 February 2018 Expiry date 05 February 2023
Chief Manager Deputy Manager Marco Morina Amanda Payne
Ente Certificazione Macchine Via Cà Bella, 243 - 40053 Valsamoggia Loc. Castello di Serravalle (Bo) Italy
Review Review Report +39.0516705141 +39.0516705156 [email protected] www.entecerma.it
Annex I
No. 3O180206.YQP0Q66
valuation Product Type E Protection Gown QK-AP001~QK-AP010 Isolation Gown QK-AP011~QK-AP020 Coverall QK-CR001~QK-CR010 Kimono QK-AP021~QK-AP030 Bedsheet QK-BS001~QK-BS010 Pillow Case QK-PC001~QK-PC010 Face mask QK-FM001~QK-FM100 Shoe Cover QK-SC001~QK-SC030
Rapport d' Rapport Oversleeve QK-OS001~QK-OS010
Under Pad QK-UP001~QK-UP010 Round Caps QK-BC011~QK-BC030 Clip Caps QK-BC001~QK-BC010 Glove QK-SG001~QK-SG010 Beard Cover QK-BV001~QK-BV010
Pants QK-NP001~QK-NP010 보고서 Bra QK-NB001~QK-NB010 Shopping Bag QK-SB001~QK-SB010 Slipper QK-SP001~QK-SP100
Apron QK-AP031~QK-AP040 검
Shoe Cover QK-SC031~QK-SC040 Oversleeve QK-OS011~QK-OS020 Visitor Gown QK-AP041~QK-AP050 Glove QK-SG011~QK-SG020 Apron QK-AP051~QK-AP060 Boot Cover QK-SC041~QK-SC050
Raincoat QK-RC001~QK-RC010 审查报告
Bathing Caps QK-BC031~QK-BC040 latex/nitrile/vinyle glove QK-SG021~QK-SG030 paper mask QK-PM001~QK-PM010 Non-slip socks QK-SS001~QK-SS010 eyemask QK-EM001~QK-EM010
Ente Certificazione Macchine Via Cà Bella, 243 - 40053 Valsamoggia Loc. Castello di Serravalle (Bo) Italy
Review Review Report +39.0516705141 +39.0516705156 [email protected] www.entecerma.it