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KG1101 Medical Examination Nitrile Gloves

KG1101 Medical Examination Nitrile Gloves

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You're protected

Our gloves will be manufactured through rigorous tests based on the corresponding regulations. We  will ensure the demand and protection in accordance with the highest quality standards.

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

Standard

240 / 9.5

Powder-Free

Textured Finger

1.5 AQL                    0.06±0.02/2.4±0.8 0.09±0.02/3.5±0.8 ≥ 14 Mpa

≥ 500%

40℃

3 Years

INTENDED USE

GEIA MEDICAL examination nitrile gloves are intended to be worn on the hands of healthcare personnel to prevent contamination between patients and examiners.This is a single-use,powder-free,non-sterile device.

FEATURES

1. Excellent mechanical strength provides a high level of hand protection.

2. Textured in finger tips for a secure grip.

3. Protection against bacteria and fungi.

4. Skin irritation&sensitization tested.

STANDARDS AND CERTIFICATIONS

ASTM D6319

ASTM F1671

EU Module C2 Certificate

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

ASTM D63193

Carton Package Design

- 10 boxes/carton

- Size:330*250*240 mm

1000 units

ASTM D63194

Container Loading

(For Reference Only/Without Pallets)

20GP                   1540 cartons

40GP                   2900 cartons

40HQ                  3400 cartons

 STORAGE INSTRUCTIONS

ASTM D63195

TEST REPORT

FDA 510K
FDA 510K2
FDA 510K3
FDA 510K4

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