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KS-ST RT021-374 Disposable Nitrile Gloves

KS-ST RT021-374 Disposable Nitrile Gloves

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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:KS-ST 021 (EN374)

PRODUCT INFORMATION

Material 

Grade

Color

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)

100%Nitrile,Sulphur and Pigments Non-Medical Grade/     Food Grade

Blue

Standard

240 / 9.5

Powder-Free

Textured Finger

4.0 AQL

0.06±0.02/2.4±0.8

0.1±0.02/4.0±0.8

 

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

Chemical manufacturing

Manufacturing and assembly

Food processing

Engineering

Electronics

Printing

Laboratory work

FEATURES

Powder free/Latex free

Excellent chemical splash protection

Excellent antiviral properties

Compliance for food-grade requirements

Diversified application scenarios

Skin irritation&sensitization tested

STANDARDS AND CERTIFICATIONS

EN 374 part1、2、3、4、5

EN 16523

EN 21420

EU Module B+C2 Certificate

EU Food Grade:EN 1186

US Food Grade:CFR 21 FDA 177.2600

Japan Food Grade:Notification NO.370

German Food&Feed Acts LFGB(30&31) and

Regulation(EC) No.1935/2004

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 ComponentsKS-ST RT021(EN 374)

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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