KG-1802 Chemotherapy-Resistant Nitrile Glove
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.
PRODUCT INFORMATION
| Material
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) Tensile strength Elongation Application Temperature Shelf Life |
100%Nitrile,Sulphur and Pigments
Blue 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)
4.0±0.3
4.4±0.3
4.7±0.3
5.0±0.3 |
INTENDED USE
The chemotherapy-resistant nitrile glove is a disposable device intended for medical purposes that is worn on the operator’s hand to prevent contamination between patient and operator.
FEATURES
Powder free/Latex free
Superior strength with better puncture resistance
Excellent chemical resistance
High chemotherapy drug resistance
Excellent antiviral properties
Skin irritation&sensitization tested
| These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows:
Carmustine (BCNU) 3.3 mg/ml
Cisplatin 1.0 mg/ml
Cyclophosphamide (Cytoxan) 20.0 mg/ml
Dacarbazine (DTIC)10.0 mg/ml
Doxorubicin Hydrochloride 2.0 mg/ml
Etoposide (Toposar) 20.0 mg/ml
Fluorouracil 50.0 mg/ml
Paclitaxel (Taxol) 6.0 mg/ml
Thiotepa 10.0 mg/ml |
Minimum Breakthrough Detection Time(minutes) 65.3 minutes
>240 minutes
>240 minutes
>240 minutes
>240 minutes
>240 minutes
>240 minutes
>240 minutes
58.3minutes |
STANDARDS AND CERTIFICATIONS
FDA 510K, K211220
ASTM D6319
ASTM D6978
ASTM F1671
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
Exterior Package Design
- Size:225*120*63 mm
100 units
Carton Package Design
- 10 boxes/carton
- Size:330*250*240 mm
1000 units
Container Loading
(For Reference Only/Without Pallets)
20GP 1540 cartons
40GP 2900 cartons
40HQ 3400 cartons
STORAGE INSTRUCTIONS
FDA 510K
ASTM D6319
ASTM D6978
ASTM F1671
