Certificate of RegistrationQUALITY MANAGEMENT SYSTEM - ISO 13485:2016

This is to certify that: ASAP International Sdn. Bhd.No.1 , Jalan Sitar 33/6Seksyen 33Shah AlamSelangor40400Malaysia

Holds Certificate No: MD 676150and operates a Quality Management System which complies with the requirements of ISO 13485:2016 for thefollowing scope:

Control of Manufacturing, Marketing and Distribution of latex and nitrile examination gloves,face masks and sterile surgical gloves.

For and on behalf of BSI:Stewart Brain, Head of Compliance & Risk - Medical Devices

Original Registration Date: 2017-12-13 Effective Date: 2019-04-23Latest Revision Date: 2019-04-23 Expiry Date: 2022-04-22

Page: 1 of 1

This certificate was issued electronically and remains the property of BSI and is bound by the conditions of contract.An electronic certificate can be authenticated online.Printed copies can be validated at www.bsi-global.com/ClientDirectory or telephone +603 2242 4211.Further clarifications regarding the scope of this certificate and the applicability of ISO 13485:2016 requirements may be obtained by consulting the organization.This certificate is valid only if provided original copies are in complete set.

Information and Contact: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP. Tel: + 44 345 080 9000BSI Assurance UK Limited, registered in England under number 7805321 at 389 Chiswick High Road, London W4 4AL, UK.A Member of the BSI Group of Companies.

TEST REPORTTEST REPORTTEST REPORTTEST REPORT

To : ASAP INTERNATIONAL SDN. BHD.To : ASAP INTERNATIONAL SDN. BHD.To : ASAP INTERNATIONAL SDN. BHD.To : ASAP INTERNATIONAL SDN. BHD. Report No. :Report No. :Report No. :Report No. : IP1706-0111-2

1, Jalan Sitar 33/6,

Seksyen 33, Page No :Page No :Page No :Page No : 1 of 2

40400 Shah Alam, Selangor,

Malaysia. Date of Issue :Date of Issue :Date of Issue :Date of Issue : 15/06/2017

Attn:Attn:Attn:Attn: Mr. Chin Tze Weng

The following sample(s) was(were) identified by the customer as : The following sample(s) was(were) identified by the customer as : The following sample(s) was(were) identified by the customer as : The following sample(s) was(were) identified by the customer as :

POWDER FREE NITRILE EXAMINATION GLOVES

SIZE: M

Date of Sample ReceivedDate of Sample ReceivedDate of Sample ReceivedDate of Sample Received : 08/06/2017

Date of TestingDate of TestingDate of TestingDate of Testing : 08/06/2017 to 15/06/2017

Objective :Objective :Objective :Objective :

Determination of the Overall Migration for Material and articles in contact with foodstuff

under requirement of Food Commission Regulation (EU) No.10/2011 following method EN 1186 at

condition of :

(i) 3% (w/v) acetic acid aqueous solution

Conclusion :Conclusion :Conclusion :Conclusion :

Test RequiredTest RequiredTest RequiredTest Required ComplianceComplianceComplianceCompliance

Food Commission Regulation (EU) No.10/2011

(Overall Migration)

[3% (w/v) acetic acid aqueous solution]

Comply

Remark :Remark :Remark :Remark : Sampled and submitted by ASAP INTERNATIONAL SDN. BHD.

Test Performed by :Test Performed by :Test Performed by :Test Performed by : Nuraini Afifah

Signed for and on behalf ofSigned for and on behalf ofSigned for and on behalf ofSigned for and on behalf of

EUROFINS NM LABORATORY SDN. BHD. EUROFINS NM LABORATORY SDN. BHD. EUROFINS NM LABORATORY SDN. BHD. EUROFINS NM LABORATORY SDN. BHD.

_______________________________

Nurul Fitriyah Abdullah, M.Sc., MMIC

Section Head (Chemistry)

IKM No. M/3945/6698/13

Customer Customer Customer Customer : ASAP INTERNATIONAL SDN. BHD. Report No.Report No.Report No.Report No. : IP1706-0111-2

Date Of IssueDate Of IssueDate Of IssueDate Of Issue : 15/06/2017 Page No.Page No.Page No.Page No. : 2 of 2

_____________________________________________________________________________________________

Sample Photograph(s):Sample Photograph(s):Sample Photograph(s):Sample Photograph(s):

Test ProcedureTest ProcedureTest ProcedureTest Procedure :

With reference to Commission Regulation (EU) No 10/2011 of 14 January 2011 Annex III and

Annex V for selection of condition and EN1186:2002 for selection of Test method.

Test Results(s) : Test Results(s) : Test Results(s) : Test Results(s) :

Extraction ConditionsExtraction ConditionsExtraction ConditionsExtraction Conditions

Analysis Analysis Analysis Analysis

Result ; Result ; Result ; Result ;

mg/dmmg/dmmg/dmmg/dm2222

Permissible Limit ;Permissible Limit ;Permissible Limit ;Permissible Limit ;

mg/dmmg/dmmg/dmmg/dm2222

3% (w/v) acetic acid aqueous solution

@ 40°C for 1 hour 6.18 10

Signed for and on behalf ofSigned for and on behalf ofSigned for and on behalf ofSigned for and on behalf of

EUROFINS NM LABORATORY SDN. BHD. EUROFINS NM LABORATORY SDN. BHD. EUROFINS NM LABORATORY SDN. BHD. EUROFINS NM LABORATORY SDN. BHD.

_______________________________

Nurul Fitriyah Abdullah, M.Sc., MMIC

Section Head (Chemistry)

IKM No. M/3945/6698/13

- End of Report -

GENERAL TERMS AND CONDITIONS

This test report / certificate issued by Eurofins NM Laboratory Sdn. Bhd., herein referred to as Eurofins NML, is in accordance

with and subject to the terms and conditions herein contained:

1. The sample(s) submitted by the customer shall be tested / analysed according to any published standard method or non-

published method as discussed and agreed upon by the customer and Eurofins NML. In the absence of any written

instruction, the customer is deemed to have agreed and accepted the standard method or technique used by Eurofins NML

in the testing / analysis of sample(s). However, Eurofins NML shall state in the report / certificate the standard method or

technique used, where appropriate.

2. The integrity of the sample(s) and result(s) are dependent on the quality of sampling. The result(s) of testing / analysis

performed by Eurofins NML is / are only applicable to the particular sample(s) received at the time of testing / analysis.

3. This report / certificate is not a certificate of quality. The results do not indicate or imply that Eurofins NML approves,

recommends or endorses the manufacturers or suppliers or users of products and it shall not be used to imply product

certification.

4. The overleaf test / analysis result(s) is / are based solely on the sample(s) submitted by the customers. Eurofins NML

assumes no responsibility for the accuracy of information on the name, type, class, brand or model number of products or

any information supplied by the customers.

5. This report / certificate is only valid when signed by an approved signatory or an authorized personnel of Eurofins NML.

This report / certificate shall not be reproduced except in full.

6. Sample(s) and any remnant sample(s) will not be retained by Eurofins NML for more than one (1) month, except with

special instruction from customer.

7. Eurofins NML shall be held harmless from any liability arising out of the use of such test / analysis result(s).

8. Presentation of test / analysis result(s) for method detection limit and unit of measurement shall be agreed by Eurofins NML

and customers, normally decided by Eurofins NML for technical reasons and good practice in analytical measurement.

9. Where relevant, a statement of compliance / non-compliance with requirement and / or specifications shall be presented

only when requested by customers. The statement shall be appropriate and needed for interpretation and guidance only.

10. This report / certificate shall not be used for advertising and legal proceeding purpose without prior written approval from

Eurofins NML.

1 1.00 True

Life Sciences

CERTIFICATE OF ANALYSISWork Order : Page : 1 of 3KL1808025

:: LaboratoryClient ASAP INTERNATIONAL SDN BHD ALS Technichem (M) Sdn. Bhd.

: :ContactContact MR CHIN TW Asliza Asan

:: AddressAddress NO.1 JALAN SITAR 33/6 SEKSYEN 33, 40400 SHAH ALAM

SELANGOR

WISMA ALS, 21, Jalan Astaka U8/84, Bukit Jelutong Shah

Alam Selangor Malaysia 40150

:: E-mailE-mail ---- Asliza.Asan@ALSGlobal.com

:: TelephoneTelephone ---- +603 7847 8257

:: FacsimileFacsimile ---- +603 7845 8258

:Project ---- QC Level : ALS Malaysia Standard Quality Schedule

:Order number 3111471330 Date Samples Received : 06-Aug-2018 17:00

:C-O-C number ---- Date Analysis Commenced : 15-Aug-2018

Sampler : ---- Issue Date : 21-Aug-2018 16:01

Site : ----

1:No. of samples received

Quote number : KL2017T GLOVE F90001 (MIGRATION FDA) 1:No. of samples analysed

This report supersedes any previous report(s) with this reference. Results apply to the sample(s) as submitted.

This Certificate of Analysis contains the following information:

l General Comments

l Analytical Results

Signatories

Signatories Position

Nazirah Ariffin Lab Supervisor - Environmental (IKM No: M/3878/6603/13)

R I G H T S O L U T I O N S | R I G H T P A R T N E R

2 of 3:Page

Work Order :

:Client

KL1808025

----:Project

ASAP INTERNATIONAL SDN BHD

General Comments

The analytical procedures used by the Environmental Division have been developed from established internationally recognized procedures such as those published by the USEPA, APHA, ASTM, NIOSH and BS EN. In

house developed procedures are employed in the absence of documented standards or by client request.

Where moisture determination has been performed, results are reported on a dry weight basis.

Where a reported less than (<) result is higher than the LOR, this may be due to primary sample extract/digestate dilution and/or insufficient sample for analysis.

Where the LOR of a reported result differs from standard LOR, this may be due to high moisture content, insufficient sample (reduced weight employed) or matrix interference.

When sampling time information is not provided by the client, sampling dates are shown without a time component. In these instances, the time component has been assumed by the laboratory for processing

purposes.

CAS Number = CAS registry number from database maintained by Chemical Abstracts Services. The Chemical Abstracts Service is a division of the American Chemical Society.

LOR = Limit of reporting

^ = This result is computed from individual analyte detections at or above the level of reporting

~ = Indicates an estimated value.

Key :

ALS TECHNICHEM prepares this Test Report based on the tests requested and on the specific sample(s) submitted for analysis. The significance of this Report is subject to the adequacy and representative

character of the sample(s) and to the comprehensiveness of the tests requested or made. ALS TECHNICHEM assumes no responsibility for variations in quality or other characteristic of the product produced or

supplied under conditions over which ALS TECHNICHEM has no control.

ALS TECHNICHEM acts for the customer from whom the instructions to act have originated. No other party is entitled to give instructions, particularly on the scope of analysis or delivery of report or certificate,

unless so authorized by the customer.

l

ALS TECHNICHEM undertakes to exercise due care and skill in the performance of its analytical and consultancy services but no warranties are given and none may be implied directly or indirectly relating to ALS

TECHNICHEM's test results, services or facilities. In no event shall ALS TECHNICHEM be liable to collateral, special or consequential damage.

l

Result < LOR = Not Detected (ND)l

Test Method:

Part (1) : The glove was cut into 2 inch square and extracted with 150ml distilled water at reflux temperature for 7hours. The glove sample was again refluxed for 2 hours with another 150ml distilled water. The

total extractives per square inch of glove for the two extractions are give below.

Part (2) : The glove was cut into 2 inch square and extracted with 150ml n-hexane at reflux temperature for 7hours. The glove sample was again refluxed for 2 hours with another 150ml n-hexane. The total

extractives per square inch of glove for the two extractions are give below.

l

3 of 3:Page

Work Order :

:Client

KL1808025

----:Project

ASAP INTERNATIONAL SDN BHD

Analytical Results

----------------NITRILE EXAMINATION

POWDER FREE GLOVE

Client sample IDSub-Matrix: SOLID

----------------02-Aug-2018 00:00Sampling date/time

--------------------------------KL1808025-001UnitLORCompound Method

Reflux with : Distilled water

Total Extractive - 7 Hours

(Distilled water)

----<0.25 ---- ---- ----mg/in20.25CFR 177.2600ø

Total Extractive -Additional 2

Hours (Distilled water)

----<0.25 ---- ---- ----mg/in20.25CFR 177.2600ø

Reflux with : n-Hexane

Total Extractive - 7 Hours

(Hexane)

----<0.25 ---- ---- ----mg/in20.25CFR 177.2600ø

Total Extractive -Additional 2

Hours (Hexane)

----<0.25 ---- ---- ----mg/in20.25CFR 177.2600ø