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KS-ST RT021-Medical Examination Nitrile Gloves

KS-ST RT021-Medical Examination Nitrile Gloves

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You're protected

Our gloves are manufactured by overcoming numerous tests based on the corresponding regulations.

GEIA MEDICAL has a daily production capacity of 1,000,000 units per line. At the end of 2021, GEIA MEDICAL will have 96 functional production lines, reaching a total daily production capacity of over 100,000,000 units.

Quality Control

ISO/IEC 17025 State Accredited Laboratory

ISO 9001 Quality Management System Certification

ISO 13485 Medical Device Quality Management System

QSR820 FDA Quality System Regulation

ISO 14001 Environmental Management System

Innovation Platform

UL-CTDP Accredited Laboratory

State Key Laboratory

National Enterprise Technology Center   

Post-doctoral Research Center

Academician Workstation

Innovation Team

5 State Council Special Allowance Experts

15 R&D Leading Academicians

108 Senior Experts

112 Senior Professional Titles

125 Doctors

651 Masters

Achievements & Honors

3 National Science and Technology Awards

15 China Patent Awards

93 Drafting and revision of national and industrial standards

Focus on supplier management, new  products development and quality control.

FDA 510K6

MODEL:KG-1101

PRODUCT INFORMATION

MaterialColor

 

Cuff length

Glove length(mm/inches) min

Powder content

External glove surface

 

Freedom from holes(Inspection level I)

 

Palm thickness (mm/mil)

Finger thickness (mm/mil)

Tensile strength

Elongation

Application Temperature

Shelf Life

100%Nitrile,Sulphur and PigmentsBlue Violet

 

Standard

240 / 9.5

Powder-Free

Textured Finger

 

1.5 AQL

0.08±0.02/3.2±0.8

0.12±0.02/4.8±0.8

≥ 14 Mpa

≥ 500%

40℃

 

3 Years

 

Size 

S

M

L

 

XL

Median Length(mm) 

≥ 240

 

≥ 240

 

≥ 240

 

≥ 240

Median Width(mm) 

80±10

 

95±10

 

110±10

 

≥ 110

Unit Weight (gram) 

3.5±0.3

 

3.7±0.3

 

4.0±0.3

 

4.3±0.3

INTENDED USE

GEIA MEDICAL nitrile examination gloves are intended for medical purposes that is worn on the examiner's hand to      prevent contamination between patient   and examiner.

FEATURES

Powder free/Latex free

Excellent mechanical strength provides a high level of hand protection.

Comfortable fit with textured fingertips for excellent tactile sensitivity.

Protection against bacteria and fungi

Skin irritation&sensitization tested

Multi-Language Packaging:

GB,DE,FR,NL,IT,ES

STANDARDS AND CERTIFICATIONS

EN 455 part1、2、3、4

EN 374 part1、2、3、4、5

EU Food Grade:EN 1186

EU Module B+C2 Certificate

MANUFACTURING ACCREDITATIONS

ISO/IEC 17025 State Accredited Laboratory

ISO 9001 Quality Management System Certification     

ISO 13485 Medical Device Quality Management System

QSR820 FDA Quality System Requirements

ISO 14001 Environmental Management System

REGULATORY COMPLIANCE

21 U.S.C. ch.9

EU 2017/745

REACH

EU 2016/425

EC 10/2011

EC 1935/2004

Package Components KG-1101

Exterior Package Design

- Size:225*120*63 mm

100 units

Package Components1

Carton Package Design

- 10 boxes/carton

- Size:330*250*240 mm

1000 units

Package Components2

Container Loading

(For Reference Only/Without Pallets)

20GP                   1540 cartons

40GP                   2900 cartons

40HQ                  3400 cartons

 STORAGE INSTRUCTIONS

ASTM D63195

TEST REPORT

Certificate1

EU Module C2 Certificate

Certificate2

EU Type-Examination Certificate

TEST REPORT

Test Report1

EN374-2&5/EN 21420

Test Report2

EN 374-4

Test Report3

EN 16523

Test Report4

REACH/ROSH


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