. prFon i? AMY ePxarma PRODUCT PROFILE /AMY Gloveswi NITRILE GLOVES eo AMY ranma CAC THONG SO KY THUAT CUA SAN PHAM PRODUCT SPECIFICATIONS Chat Lieu Cao su Nitrile nhan tao Material Synthetic Nitrile latex. Khdng bét chua tiét tring. Non-Sterile Power-Free Dung cho od 2 tay; bé mat du ngén tay nham; xe vién 6 tay; mau xanh duong va trang Ambidextrous; Finger Tip Texture; Beaded Cuff; Blue and White Phil hgp véi cdc tisu chudn ASTM D6319 va EN455-1/2/3/4 Conforms to ASTM D6319 and EN455-1/2/3/4 Sn xuét theo hé théng quan ly chat lugng ISO 9001:2015, ISO 13485:2016, FDA, CE Manufactured under ISO 9001:2015, ISO, ISO 13485:2016, FDA, CE Quality Management System. Sn xudt tis 100% nitrile (Acrylonitrile-Butadiene) Manufactured trom 100% nitrile (Acrylonitrile-Butadiene) Extra Small, Small, Medium, Large, Extra Large Duge danh dau Size trén thiing hang bang muc den. Black marked in the check box on the shipping carton Loai Type Tigu Chun Chat Luong Quality Standards Kich thuéc gang tay Gloves Size Bao quan Bao quanh noi khé réo mat mé, nhiét dd khéng cao hon 38°C. Storage Store in a cool and ary place, temperature is not higher than 38°C Han st dung 3 nam ké ti ngay san xuat Shelt-lite 3 years trom the date of manutaturing.KICH THUGC PHYSICAL DIMENSIONS . Tiéu Chuan KiCH THUOC cea oe AMY PHARMA ASTM D6319 Chigu dal (mm) 220 min (XS.S) Length ao 230 min (M,L.XL) 75 £5 (XS) 70 + 10 (XS) 85 + 5(S) 80 + 10(S) nies rong (mp) 95 +5 (M) 95 + 10 (M) 105 #5 (L) 110 + 10 (L) 115 +5 (XL) 120 + 10 (XL) Doday (mm) —_| : eae : gon tay (Fingers): 0.08 mm min | Ngén tay (Fingers): 0.05 mm min Thickness-Single wall) 44 ban tay (Palm): 0.06 mm min| Long ban tay (Palm): 0.05 mm minCHi TIEU LY HOA PHYSICAL PROPERTIES AND Bi OMPATIBILITY - ; (MPA) Tensile strength (MPA\ L 9} Tuc Iaio héa (Before Aging) : 18Mpa| T (Before Aging): 14Mpa | min . min Sau [do héa (After io héa (After Aging): 14Mpa Min Min ‘Tensile | Elongation at break (%) Elongation at break (%) _ | Truéc lao héa (Before Aging): 600% | Trude ldo héa (Before Aging): 500% ' min min ® Sau lao héa (After Aging): 500% min | Sau lao héa (After Aging): 400% min Ham long bot Ti da 2mg/ gang Powder Content 2mg/glove maximum Ham lugng protein " Khéng cé Protein Protein Ce Protein Free Chiic nang - Bao vé khdi cdo chat khéng mong muén hay nguy hig: Xe vién 6 tay gidp cho deo gang dé dang va tranh tinh trang b| cudn xuéng = C6 sui dé0 dai tuyét voi vdi kha ndng chéng thiing t6t hon = Co bé mat toan b6 ging nhém hoac nham dau ngén tay giup tang kha nang cém ném oa khi khé va ust = Méng hon glip tang d@ nhay cam xiic gic - Thiét k6 danh riéng cho sy thoai mai va vila vain - Cung cp mét gidi phap thay thé cho nhng ngudi | ling véi cao su ty nhién ‘ Functional Benefits - Protection from unwanted and dangerous substances - Beaded cutf ensures easy donning and prevent roll down - Superior strength with better puncture resistance - Full textured or Finger Tip textured enhances wet and ary grip - Thinner gauge improves tactile sensitivity = Custom design enhances comfort and fit - Provide an alternative solution for individuals who are allergic to natural rubber latexHOP SAN PHAM PACKAGING KT: 23.5 x 11.8 x 7.4m THUNG DUNG GANG TAY CARTON BOX Wien muse ing dango et one 2em 386m tem p= = = "HUNG GANG TAY DUNG 1 HOP YONG}CHUNG CHi ERTIFICATEDANG Ki KINH DOANH BUSINESS REGISTRATION CERTIFICATE eu. Godt O we ae “SOx Ho wa pau “connor nl ier st Diep Ty do ~ 1 mmondtDAne nent aN ee "Yoel GIAY CHUNG NUAN DANG KY DOANHLNGHIEP . tif - % # coset co PHAN * M. * | Mitsb doanh nghigp: 0108751280 aang iy lind: mgt 22 hang OS nim 2019 | Bagh thay aK ht 2 ry 12 thing 6 nm 2020 © ¥ ; é * 1 Tia oti, tae eee yah e ige a Teneo ty vide ‘ing Viet: CONG TY CO PHAN TAP DOAN AMY ‘Tén céng ty viet big tiéng nuxée ngoai: AMY GROUP JOINT STOCK COMPANY 2 -Tén eding ty viet tit: AMY GROUP JSC I me” ae 2. Dja ehi try strehinh 25. ae e oS. # wi oe Ot ss 1g chits Moe trim 0 dé : + ; - So ‘Mgnh gid eb phin: 10.000 ding St Pt S © Thags6 ob ph: 10000000 SMP * 4 gui gi dif theo phip lujt cia cng ty, "4 ova ten: NGUYEN MANH THANH Chit da i ch HOH Ang quan tej a a Sinh gly: 1710/1963 Dine: Kink” Qube tich: VietNam Logi gily wt chimg thye cd nhin: = Thé edn cide céng dan GiGi tinh; Nam * ‘86 sity. eng i orig Bak % m, & i Naty olp: 157082019 Noi cl: Che Onn Ni ct e F cpr: A a Se Pi Peake nisae ee Ds 4 a Ps a ge Rare os Coote Mi en phd Ha a Hf av % % is K ie PO Gop 2 : Hg éh So AMY SancinaBANG Ki KINH DOANH BUSINESS REGISTRATION CERTIFICATE Fe ; * ": 5 Abst % Me # “ a * Cow Mat. ‘ “fos pvona nde a ii tks Nam fa ae ad Ting gdm dbo | Sinh 1SI001888. Dine: Kinh use ies Viet Nam Logi gidy ta ching thye cé nhim: 116 chiéu Vige Nam og "Sb gly cig teed nha: 2243 Te Neiy 28/08/2013 Noi ep: Cue quan hd eine ily ting hp “vatnipi Ouin Bie “ys Hraaeier po graye Ch hin otnaten hig ih un Bis hg aa en ar So o AMY exarmaISO 13485:2016 ISOCERT INTERNATIONAL INSPECTION AND ; CERTIFICATE No, 1869293400963-MED_ ‘THIS 1S TO CERTIFY THAT THE QUALITY MANAGEMENT SYSTEM POR MEDICAL DEVICES OF: AMY GROUP JOINT STOCK COMPANY {Hemigoare: Ne 246288 Vo Chi Cong Sie, ian Wa, oy Dirt Hw Cy, Vico aera Ne aC Cin ih nhl Pe, i id Dri ae Nish Prin, Vat. 2016 Has been assessed and found to conform with the requiernents ofthe following standart ISO 13485:2016 ‘SCOPE CERTIFIED: Manufacturing and trading medical masks, N95 medical masks, medical rubber gloves. 34012020 (03 Ju 2020 2.402 tr) ea) = oe cf oS Ee = =) ad — = Oe habe tr) AND INSPECTION JOINT STOCK COMPANY ‘hin: Pons si Mate OTN MEA tee WTAESC IA a emai abe Me & o AMY xaraISO 9001 CONG TY CO PHAN CHUNG NHAN QUOC GIA GOOD VIET NAME ‘GOOD VIET NAM NAFIONAL CERTIFICATION JOINT STOCK COMPANY. GIAY CHUNG NHAN CERTIFICATE CHONG NAN ME THONG QUAN LY LAT LONG CONG TY CO PHAN TAP DOAN AMY AMY GROUP JOINT STOCK COMPANY > AMYerour DIA cH ADRESS: ein ead 8 286-288 Dung VO.CHI Cog, Pong Xu Ls, Qa Thy 1, THA Nb VEN No, 256-258 FOC Cong Sr, hen Lard Tayo Dirt, Heed Ci, Vane [Nn my! Facer: Thin ¥en Lh, x4 Dh Ti Haya Kho Chia Tin Marg Yee, VIM Naw Yoo Leh Hie, Dan To Comm, Khoa Ch si, Homy Yen Provin, nan DUIGC DANN GIA PiU HOR VOR Che VEU CAU COA TiBU CHUAN: ‘AS WEEN ASSESSED AND FOUND YO COMPLY WIT THE REQUIREMENTS OF: 150 9001:2015 ‘eno enam vw rox score Sin au, kinh oan hd tramg y tf Kh phing dich, Mannficturing and wading of medieal masks, anibactertal mano cloth mass; protetive clothing? shenine bv Copa: GOODY iRE.ONS eave twee" Guan Git dh ape de pavenenexnay af 4 a I = i= Bee i tang vii mano hing Khu, bp a "NGUYEN DO SON gst tie deg taf ch bh Ag va gee ah fh ag ae DOONN, ‘cratic sb esesone’ wanna se ps rt COOH AMYexarmaCE Certificate of Compliance Application for Medical Device Directive (MOD) 93/42/EEC. ‘Ths is to certify that the product(s) Medical Masks (3-Layer Medical Face Masks, 4-Layer Medical Face Masks) Medical Gowns (Non-Surgical Isolation Gowns, Surgical Isolation Gowns) Protective Clothes (Protective Coveralls) Medical Gloves (Nitrile Gloves/Non-Powdered Gloves), NOS Respirator (Respirator, Surgical) Manufactured by AMY GROUP JOINT STOCK COMPANY ‘No. 266-258 Vo Chi Cong Street, Xuan La Ward, “Tay Ho Distriet, Ha Noi City, Vietnam Complies with the requirement of the “EN 14683:2019; EN 149:2001 + A1:2009; EN 14126:2019; EN 455.1/2/3/4" has been assessed & found in accordance with the requirements of MDD 93/42/EEC as amended by 2007/47/EC Class | (Non-Sterile), on-notified certification body, issue this ler audit of manufacturer product(s) & technical file(s). This certificate applies to the tested sample only not for whole production. It's manufacturer sole responsibility to meet all the necessary conformity assessment activities according to MDD 93/42/EEG and related standards bbofore placing them on the market & CE mark on the product(s). Certiicate No. = GE/016118/0320 Original Certticate Date: 30 - April -2020 Issue Date +: 80-April-2020 Expiry Date 29 - April 2024 “ppsivasl uk comicerttiedorganeaton tm” te ce As ‘atbonsed Signature For Quality Control Certification Ux ofc: 1928, Chynowat House, > AMY exarmaFDA ETE eR Certificate of Registration This certificate of Registration certifies that AMY GROUP JOINT STOCK COMPANY No. 256-258 Vo Chi Cong Street, Xuan La Ward, Tay Ho District, Hanoi City, 10000, Vietnam oer ws ike US fed andra Ansan pursue 1 Ti 21 ofthe Unt States Co of Feel ‘ais. ‘Owner Operator Number: 10073658 Listed Device KR 401579 Face Mask (except N95) EA. 401560 Non-surgical Isolation Gown MSH 401978 Respirator, Surgical TWP D410074 Radiographic Protective Glove US Agent: Willow Glen Consultancy LLC Willow Glen Number: WG2071183 Expiration Date: December 31, 2020 ‘Tas cent affirms that the abovesasmed facility is mitered wit the US ROA pursuant othe mgulatinsruied bythe US Laws Te rgitration as boon vefed as affirve by Vllow Glen Conley sof the date ew, unen sch mitration has bee terminated after auance of is Comificae Wow Gln Concliancy mesmo ational representation a warranties, nor dvs is ‘enfiate cary ay to any porno entity lhe a the named eect her, for wha sle boi it ‘sisued. Willow Glen Consultancy asain no Giity to any person o entity in connection wth the fomgoing nor dacrthe OS WOM rvagnice a cerfcte of mgitaton ted by Wow Glen Consultancy. Willow Glen Conslancy isa private agent not afte wih ke US Fou and Dray Adnisration CmardbOn Willow Glen Amanda Ou, Operation Director WillowGlenFDA.com Willow Glen Consultancy LLC Info@WillowGlenFDA.com 1-619-869-0249 3755 Avocado Blvd, Suite 208 Date: May 13, 2020 La Mesa, CA 91941, USA TIS Ta TEA TS re a Sli a SAN. TS AMY pxarma