Test Report No. 7191212955-EEC19/03-WBH_CR3 dated 03 Sep 2019 (Tov ww Note: This report isesues subject tothe Testing and Cariicaton Regultons ofthe TOV SUD Grup andthe tena of Gusness of TOV SUD PSS Pls Ltd In dain, thi epot govemed by the terme stout win tis repr. PSB Singapore ECT: ‘Add value. Testing of Examination Gloves submitted by Inspire trust RG KHAl HOAN JOINT STOCK COMPANY on 12 Aug 2019. TESTED FOR: VRG KHAl HOAN JOINT STOCK COMPANY Cau Sat Hamlet, Lai Hung Commune, Bau Bang District, Binh Duong Province, Viet Nam. TEST DATE: 13 Aug 2019 to 03 Sep 2019 DESCRIPTION OF SAMPLES: | Sample Product | Brand/ | 4, Expiry SIN] eserption | Size | Colour | Loto, | TARO | received | Manufacturer ee (pieces) Powder Free! 1 Tete |e M_ | Blue’ |Nooszo19| 08.2021} 998 | VRGKHAIHOAN “Gloves one JOINT STOCK = COMPANY Lot size as specified by client: 35,001 to 150,000 pieces METHOD OF TEST: 1. EN 455-1:2000 Medical gloves for single use Part 1: Requirements and testing for freedom from holes 2. _ EN 455-2:2015 Medical gloves for single use Part 2: Requirements and testing for physical properties 3. _ EN 455-3:2015 Medical glove for single use Part 3: Requirements and testing for biological evaluation Tuvst0 ps8 Latent Po ees 50 gj: tovstofea ei Px eSareoe TV SID Aue eis Ter Swe fosone Sia eegisnin Teena at Syeaeien fon scp Scopes ne oho. otaere seme Page 1 ofTest Report No. 7191212955-EEC19/03-WBH_CR3 dated 03 Sep 2019 8 Sogepre RESUL’ ‘Sample: Powder Free Nitrile Examination Gloves, V Glove, Size M Table 1; Results for EN 455-1:2000 No.of __] Number] AgwaTWO. oF | inrereq Clause | Tests | Requirements | non-compliers | tested | non-compliers | Inferred allowed (pieces) | (pieces) | found (pieces) = 4] Freedom 4] Freedom | shall not leak 7 200 1 Passed Table 2: Resulls for EN 455-2:2015 Clauses 4:5 Requiremenis | Numbertested | Resulls | Inferred cad uct (Median) (pieces) (Median) | _resuits Dimensions > 4 [ettenath am [2240 13 jas Passed b) Wath (mmm) eet 13 98 Passed For nitrile Strength examination a) Force at break 13 62 Passed ™ loves: 26.0 5 | byForce at break ater catenge | Fontan tesing (| examination ‘3 e7 | Passed Teaga |g qos2)°c : Table 3: Results for EN 455-2:2015 Clause 7 intered clause | Tests Requirements Resutts | inered Manufacturers shall label he glove andlor the packaging with the date of manufacture in accordance with EN ISO 15223-1:2012 7 | Labeling | and EN 1041:2008+A1:2013. Date of erserved! "| Passed manufacture is defined as the packaging date Page 2.of5Test Report No. 7191212955-EEC19/03-WBH_CR3 dated 03 Sep 2019 P88 Segapore RESULTS (cont'd ‘Sample: Powder Free Nitrile Examination Gloves, V Glove, Size M Table 4: Results for EN 455-3:2015 Clauses 4,2-4.5 Inferred Clause | Tests Requirements Results / Remarks eres Glove is talcum powder-free Gloves shall not be dressed with talcum powder (magnesium silicate). Bove ate on cancel | essed fot lene feclaration letter Manufacturer shall disclose Other chemicals upon request a list of NA chemical ingredients 43 < 20 EU/pair for gloves labelled with Not labelled with ‘low 5.4 _| Endotoxins | iow endotoxin content endotoxin content S 44, | Powder | Fo" Powder-free gloves: The total 82 | free gloves | Auantity of powder residues shall not 0:52 mg per glove Passed g exceed 2 mg per glove. “The manufacturer shall strive to £3 | RRS. | minimize the leachable protein level for | NOt natural pber latex: NA loves containing natural rubber latex. 9 Table 5: Results for EN 455-3:2015 Clause 4.6 Clause | Tests Requirements Results In addition to the labelling specified in EN 1041:2008+A1:2013 and the relevant symbols given in EN ISO 15223-1:2012, the following requirements apply: a) medical gloves containing natural rubber latex shall be labelled on the packaging of at least the smallest packaging unit with the EN NA 180 15223-1:2012 symbol for latex: The labelling shail include the following or equivalent waming statement together with the symbol: (Product) contains natural NA rubber latex which may cause allergic reactions, including anaphylactic responses’ b) the labelling shall include a prominent indication of whether the ae 48 | Labelling glove is powdered or powder-free; td ©) sterile powdered gloves shall be labelled with the following or equivalent: ‘CAUTION: Surface powder shall be removed na aseptically prior to undertaking operative procedures in order to minimize the risk of adverse tissue reactions’; 4) for any medical glove containing natural rubber latex the product labelling shall not include: ~ any term suggesting relative safety, such as low allergenicity, NA hypoallergenicity or low protein - any unjustified indication of the presence of allergens; e) ifthe manufacturer labels the gloves with the protein content, the NA process limit, measured as specified in 5.3 shall be given. Inferred results | Passed Page 3 of 5 sic HlTest Report No. 7191212955-EEC19/03-WBH_CR3 dated 03 Sep 2019 REMARKS: 1. Labelling requirements are assessed based on submitted packaging artwork by client. 2. NA: Not applicable for the submitted sample. 4s Poh Kwang £ Bee Hui Associate Engineer Product Manager Medical Health Services (NAM) APPENDIX: Photo 1: Powder Free Nitrile Examination Gloves, V Glove, Size M Photo 2: Artwork for Powder Free Nitrile Examination Gloves, V Glove, Size M Page d of 5Test Report No. 7191212955-EEC19/03-WBH_CR3 dated 03 Sep 2019 Tw) 8B Singapore Please note that this Report is issued under the following terms: 1. This report apples tothe sale ofthe specific productlequpment given atthe tne of ts testingalration. The resus are not used to indicate or mpl that they are eppicabl o other similar ites. In ako, suc resus must not be used to indicate or mpiy that TU SUD PSB approves, recommends or endorses the manufacturer, supplier or user of such procucteuipment,or that TUV SUD PSS in any way “guarantees the llr perrmance of the producvequpment Unless otervse stated in bis pot, no tess were conducted to determine long tem efecsof using the specific produtequpment 2. The sampols mentioned in this report iste submitedsuppliedimanufactured by the Client TUV SUD PSB therefore assumes no responsibiy forthe accuracy of information on the brand name, model number, agin of manufacture, consgrment or any information supple. 3. Nothing in he report shall be intrprated o mean that TOV SUD PSB has veri or ascertained any endorsement or marks tom any eter {esing authority orbodies that may be found on ta erp “4. This report shal not be reproduced whaty orn parts and no reference shal be made bythe Cbent fo TOV SUD PSB orto the report or resus ‘umished by TOV SUD PSB in any adverisement or sees promotion, 5. Unless otherwise state, the tests were cared outin TUV SUD PSB Pl Lt, No.t Science Park Drive Singapore 118221 sty 2011 Page of 5