Wimax Gloves

31/40 KRUNG THEP KRITHA ROAD, THAP CHANG SUB- DISTRICT,SAPHAN SUNG DISTRICT, BANGKOK

Wimax Group Co.,Ltd wasestablished in 2010, with theirinitial business focused on retailsale of sporting equipment inspecialized stores. As a result ofthe pandemic crisis in 2020Wimax made a joint ventureagreement with Medical GloveCo., Ltd and JDC CorporationCo., Ltd. to utilize theirexperience in marketing, salesand export trade to distributePersonal Protective Equipmentnamely “Examination Gloves”manufactured in Thailand.

Wimax Gloves

Expert Solutions Quality Assured

WIMAX GLOVES (THAILAND) CO., LTD “WIMAX” has partnered with MEDICALGLOVE CO., LTD to facilitate the introduction of a premier high quality fullycertified and registered line of protective examination gloves. As a result of theCOVID-19 global pandemic it is understood that there will be shortages of qualitypersonal protective equipment “PPE” around the world. WIMAX has decided todevote investment, time, resources, retail experience and their global salesnetwork through teaming with a Medical Glove Company Ltd. a leadingmanufacturer of Natural Rubber (NR) and Nitrile Butadiene Rubber (NBR) glovesfor applications in both medical and general-purpose markets. The core value ofthe partnership is to provide the best quality protective products at a fair price tothose in need.The MG Glove Company is the result of a recent acquisition of a historic marketleader in the glove manufacturing industry. The actual MG Glove manufacturingplant located in provinces of Krabi, in the south of Thailand. commenced ouroperations by producing latex gloves for various medical fields. The factory issurrounded by thousands of acres of rubber tree plantations giving it theadvantage of having the natural latex materials in the vicinity at hand.

Wimax Gloves

Glove Manufacturing Facilities

We use our in-house special formulation in the compounding process. Our manufacturing facilities are specially designed and built with unique features to produce gloves to meet our customers stringent requirement.

Wimax Gloves

1. Device Trade or Proprietary Name: Nitrile Examination Glove Tested For Use with Chemotherapy Drugs

2. Device Common or Usual Name: Examination Glove

3. Device Classification Name: Nitrile Patient Examination Glove (Powder Free)

4. Description of the Device: Non Sterile, Powder-Free, Nitrile Examination for Use with Chemotherapy

5. Intended Use of the Device: This is the disposable device intended for medical application that is worth

examiner’s hand to prevent contamination between examiner and patient

protect examiner from the following Chemotherapy drugs tested to ASTM with

the indicated Breakthrough Detection Times :

Wimax Gloves

Product Data Sheet – Nitrile Examination Glove Tested For Use with Chemotherapy Drugs

Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.

Nitrile Powder Free Examination Glove Blue

Carmustine (BCNU) 40.00

Cyclophosphamide (Cytoxan) > 240

Doxorubicin HCl (Adriamycin) > 240

Etoposide (Topotar) > 240

Fluorouracil > 240

Paclitaxel (Taxol) > 240

Thio-Tepa 177.00

Cisplatin > 240

Dacarbazine > 240

Thickness min 0.1 mm

Product Data Sheet – Latex Powder Free Examination Gloves

Wimax Gloves

Characteristics Inspection Level Acceptable Quality Level Reference Standard

Freedom from holes - Barrier G1 1.5ASTM 5161

EN 455-1

Visual Defect● Major Visual● Minor Visual

G12.54.0

Industry Practice

Dimensions S-2 4.0ASTM D3578

EN 455-2

Phys ical Properties S-2 4.0ASTM D3578

EN 455-2

Ris idual Powder Content N = 5 N/A ASTM D6124EN 455-3

Protein ContentN = 3 N/A ASTM D5712N = 8 N/A EN 455-3

Phys ical Variable Size Speci fication Limits Reference Standard

Length (mm) Al l s izesMin 230

Min 240

ASTM D3578

EN 455-2

Pairs Width (mm)

XSSML

70 ± 1080 ± 1095 ± 10

111 ± 10

ASTM D3578

XL 120 ± 10In houses /

Customer requireXSSML

XL

≤ 8090 ± 1095 ± 10

110 ± 10≥ 110

EN 455-2

Thickness (mm)*s ingle wall

Al l s izes

Middle Finger 0.110 ± 0.02Palm 0.080 ± 0.02 (3.8-4 mi l )

ASTM D3578

Cuff 0.070 ± 0.02In houses /

Customer require

PropertiesSpecification Limits

Before Aging After Aging Reference Standard

Elongation at break Min 650 Min 800ASTM D3578

Tensile Strength (MPa) Min 18 Min 14

Force at Break (N) Median 5 Median 6 EN 455-2

Residual Powder Content Max 2 mg/gASTM D8124

EN 455-3

*Protein ContentMax 200𝜇g/dm^2 ASTM D5712

N/A EN 455-3

Wimax Gloves

Product Data Sheet – Nitrile Powder Free Examination Gloves

Wimax Gloves

Product Specification Features

Brand WIMAX ● Fingertip Textured

Product Nitrile Examination Glove, Powder Free, Non sterile, Disposable ● Powder Free

● No Natural Latex

Powder Content Maximum 2.0mg per Glove ● Lab Chemical Tested

Protein Content N/A ● Ambidextrous

Size S - 80±10, M - 95±10, L - 110±10, XL - 115±10 ● Blue color

Avg Width (mm) 100 ± 10 ● Chlorinated

Avg Weight (g) 3.8 ± 0.3

Length (mm) Min 240 (9") Packaging

Thickness Cuff 0.070 ± 0.02 100 Pieces Per Box

Palm 0.080 ± 0.02 (3.8-4 mil) 10 Boxes per Carton (1,000 Pieces)

Finger 0.110 ± 0.02

Physical Properties - ASTM 20FCL - 1,300 Cartons (13,000 Boxes)

Parameters Tensile (MPa) Elongation Break (%) Modulus 500% (Mpa) 40FCL - 2,600 Cartons (26,000 Boxes)

Before Aging 40HQ - 3,200 Cartons (32,000 Boxes)

Medella Result 18 650-670 Max 2.8

ASTM Requirement Min 14 Min 650 Max 2.8 Regulatory Compliance

After Aging MDD 93/42/EEC

Medalla Result 16 500-650 Max 2.8 FDA 510K / Class 1

ASTM Requirement Min 14 Min 500 N/APhysical Properties - EN Standards

Parameters Force Break (N) Elongation Break (%) ASTM D6319, D6124-06, D6978-05

Before Aging EN ISO 374-1:2016

Medalla Result 9-11 N/A EN ISO 374-5:2016

ASTM Requirement Min 9 N/A ISO 2859-1

After Aging EN 374-4:2013

Medella Result 6-10 N/A EN 420:2003 +A1:2009

ASTM Requirement Min 6 N/A EN 388:2016 +A1:2018

Performance EN 455-2

Inspection Related Defects Inspection Level AQL

Watertight Test MolesG-1

1.5 Manufacturing Accreditations

Visual Inspection Major Defects 2.5 ISO 9001:2015

Minor Defects 4.0 ISO 13485:2016

Physical Properties Tensile S-2 4.0 GMP Certified

Physical Dimension Measurement S-2 4.0

Wimax Gloves

Wimax Gloves

Wimax Gloves

Certificates

CORPORATE PROFILE

MEDICAL GLOVE CO., LTD

Your most reliable partner in hand protection and

safety.

WHO ARE WE

Medical Glove is a newly established medical glove manufacturing company with

manufacturing plants located in provinces of Krabi, south of Thailand.

Wimax Gloves

Certificates

MEDICAL MANAGEMENT SYSTEM CERTIFICATION STATUS

1. QUALITY MANAGEMENT SYSTEM CERTIFICATION BY BSI

• ISO 13485: 2016: Certification Number; MD 716521

• ISO 9001: 2015: Certification Number; FM 716518

2. US DFA 510(K)

• K162381:MG PRO XP© Nitrile Powder Free Examination Gloves Tested For Use withChemotherapy Drugs

• K152479MG PRO© Nitrile Powder Free Examination Gloves

• Latex Powder Free Examination glove is in-progress

3. CE and EN TEST CERTIFICATES

SATRA EC Type-Exam Certificate1. EN ISO 21420: 20202. EN ISO 374-1:2016+A1:20183. EN 374-2: 20194. EN374-4: 20195. EN374-5: 20166. EN16523-1: 2015-A1: 2018

• Nitrile Powder Free Examination gloveEU Type-Examination Certificate Number: 2777/14960-01/E00-00

• Latex Powder Free Examination gloveEU Type-Examination Certificate Number: 2777/15031-01/E00-00

4. TUV Riehland or Songkhla Medical Sciences Lab Test Reports

• Nitrile Powder Free Examination glove• Latex Powder Free Examination glove• EN455-1, EN455-2

Wimax Gloves

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Wimax Gloves

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Wimax Gloves

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Wimax Gloves

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Wimax Gloves

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Wimax Gloves

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Wimax Gloves

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Wimax Gloves

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Wimax Gloves

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Wimax Gloves

JOINT VENTURE AGREEMENT