0% found this document useful (0 votes)
507 views24 pages

Biotech Gloves - Certifications - Opulent

Nitrile Gloves; PPE; certificates; covid19; supply; Biotech; Opulent; FDA 510k; EN 455; EN 374: EN 420; Satra

Uploaded by

saisridhar99
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
507 views24 pages

Biotech Gloves - Certifications - Opulent

Nitrile Gloves; PPE; certificates; covid19; supply; Biotech; Opulent; FDA 510k; EN 455; EN 374: EN 420; Satra

Uploaded by

saisridhar99
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 24

contact sridhar@opulententerprises.

com
www.opulententerprises.com
contact [email protected]
www.opulententerprises.com

TK HITECH TECHNOLOGY CO., LTD.


1/221 Venish De Iris, Watcharapol
Tha rang, Bang Khen Bankok, 10220
T: ++66(0)2-003-8217
contact [email protected]
www.opulententerprises.com

Chonburi Rayong

Factory
location
Biotech runs four factories at four sites.
Chonburi, Rayong, Phuket, and Songkhla.
The overall capacity is more than 4000 million Phuket Songkhla
gloves per month and the capacity is
constantly increased.
contact [email protected]
www.opulententerprises.com

Manufacturer
We are a manufacturer of rubber glove and
synthetic rubber that produces international
hygiene quality standards for various applications
including medical, food and laboratory etc.,
our products have been exported
to over 25 countries worldwide.
01
contact [email protected]
www.opulententerprises.com

Nitrile Powder-Free
Examination Gloves 4.0 mil
contact [email protected]

Nitrile Powder-Free www.opulententerprises.com

Examination Gloves 4.0 mil


Product Specifications

TYPE
Medical Examination Glove
Powder-Free
Non-Sterile

MATERIAL
100% Synthetic Nitrile
(or Acrylonitrile-Butadiene)
100% Latex Free
No Natural Latex Rubber Protein

DESIGN AND FEATURE


Ambidextrous
Textured
Beaded cuff
contact [email protected]

Nitrile Powder-Free www.opulententerprises.com

Examination Gloves 4.0 mil


Product Specifications

POWDER
Powder-Free

QUALITY CONTROL
Suppliers must follow the ISO 2859-1 or equivalent
quality requirements for sampling procedures.
Items must attain the AQL level
before release for delivery

AQL (Acceptance Quality Level)


1.5% Freedom from Hole
2.5% Major Visual Defect
4.0% Minor Visual Defect
contact [email protected]

Nitrile Powder-Free www.opulententerprises.com

Examination Gloves 4.0 mil

Product Standard
DIMENSIONS BIOLOGICAL SAFETY
ASTM D6319-10 EN 455-3 : 2015
EN 455-2 : 2000

PHYSICAL PROPERTIES FREEDOM FROM HOLES


ASTM D6319-10 or (BARRIER 1000ml WATER LEAK TEST)
EN 455-2 : 2000, FDA 1000ML TEST METHOD
or ISO 11193-1 ASTM D5151-06
EN 455-1 : 2000

P PROTEIN CONTENT
ASTM D5712-10, if applicable
POWDER FREE RESIDUE
ASTM D6124-06:2017
contact [email protected]

Nitrile Powder-Free www.opulententerprises.com

Examination Gloves 4.0 mil


Product Specifications
SIZES
X-Small (XS), Small (S),
Medium (M), Large (L)

MINIMUM LENGTH
240mm
Dimension of Gloves Length (mm) Min 240 mm
Dimension of Gloves Palm Width (mm):
a. Extra Small = or < 80 mm
b. Small 80 +/- 10 mm
c. Medium 95 +/- 10 mm
d. Large 100 +/- 10 mm

Thickness (mm) Single Wall / All Sizes :


a. Finger min 0.07 mm
b. Palm min 0.06 mm
c. Cuff min 0.05 mm

CONFORMANCE TO QUALITY SYSTEM STANDARDS


The supplier shall comply with the standard set forth in
ISO 13485/13488 or EN 46001/46002 or equivalent standards.
contact [email protected]

Nitrile Powder-Free www.opulententerprises.com

Examination Gloves 4.0 mil


Product Specifications
Dimension of Gloves Length (mm) Min 240 mm
Dimension of Gloves Palm Width (mm):
a. Extra Small = or < 80 mm
b. Small 80 +/- 10 mm
c. Medium 95 +/- 10 mm
d. Large 100 +/- 10 mm

Thickness (mm) Single Wall / All Sizes :


a. Finger min 0.07 mm
b. Palm min 0.06 mm
c. Cuff min 0.05 mm

CONFORMANCE TO QUALITY SYSTEM STANDARDS


The supplier shall comply with the standard set forth in
ISO 13485/13488 or EN 46001/46002 or equivalent standards.

Physical Properties (Before Aging)


a. Tensile Strength (MPa) Min 14
b. Elongation (%) Min 500

Physical Properties (After Challenge Testing)


a. Tensile Strength (MPa) Min 14
b. Elongation (%) Min 400
contact [email protected]

Nitrile Powder-Free www.opulententerprises.com GLOVES, MEDICAL EXAMINATION, POWDER FREE, NON-STERILE, NITRILE

PRODUCT SPECIFICATIONS

Examination Gloves 4.0 mil


1 TYPE Medical Examination Glove, Powder-Free, Non-Sterile
2 MATERIAL 100% Synthetic Nitrile (or Acrylonitrile-Butadiene),
100% Latex Free, No Natural Latex Rubber Protein
3 DESIGN AND FEATURE Ambidextrous, textured, beaded cuff

Summary Specification Sheet 4


5
POWDER
QUALITY CONTROL
Powder-free
The supplier to comply with the ISO 2859-1 or equivalent standards for
sampling procedures for inspection. Item needs to achieve the AQL
level before release for supply
AQL (Acceptance Quality Level)
1.5% Freedom from Hole
2.5% Major Visual Defect
4.0% Minor Visual Defect
The Supplier shall provide the detail of Major and Minor Visual defects
6 PHYSICAL PROPERTIES FREEDOM FROM HOLES (BARRIER 1000ml WATER LEAK TEST)
Physical Properties (Before Aging) - a. Tensile Strength (MPa) Min 14
Physical Properties (Before Aging) - b. Elongation (%) Min 500
Physical Properties (After Challenge Testing) - a. Tensile Strength
(MPa) Min 14
Physical Properties (After Challenge Testing) - b. Elongation (%) Min 400
7 REFERENCE STANDARDS ASTM D6319-10
EN 455-2 : 2000
ASTM D6319-10 or
EN 455-2 : 2000, or
ISO 11193-1
FDA 1000ML TEST METHOD
ASTM D5151-06 or
EN 455-1 : 2000
CE2777
FDA510K
POWDER FREE RESIDUE ASTM D6124-06:2017
BIOLOGICAL SAFETY EN 455-3 : 2015
PROTEIN CONTENT ASTM D5712-10, if applicable
8 AVAILABLE SIZES Extra Small (XS), Small (S), Medium (M), Large (L)
9 DIMENSION Length (mm) Min 240 mm
Dimension of Gloves Palm Width (mm):
a. Extra Small = or < 80 mm
b. Small 80 +/- 10 mm
c. Medium 95 +/- 10 mm
d. Large 100 +/- 10 mm
Thickness (mm) Single Wall / All Sizes :
a. Finger min 0.07 mm
b. Palm min 0.06 mm
c. Cuff min 0.05 mm
contact [email protected]
www.opulententerprises.com

Nitrile Powder-Free
Examination Gloves 4.0 mil
100 pcs / box
Nitrile Powder-Free
Examination Gloves 4.0 mil
contact [email protected]
www.opulententerprises.com

Nitrile Powder-Free
Examination Gloves 4.0 mil
Packaging Specification

CARTON BOX
contact [email protected]
www.opulententerprises.com

Nitrile Powder-Free
Examination Gloves 4.0 mil
Product Loading Proposal for 40’HQ

Estimated first shipment by end of July


Assumptions :
35,200 boxes/container
10 boxes/carton
80 cartons/pallet
44 pallets/container
Pallet size 105x 98 x 115 cm
Pallet weight 500 Kg
contact [email protected]
www.opulententerprises.com
Nitrile Powder-Free
Examination Gloves 4.0 mil
Product Loading Proposal for 40’DC

Assumptions :
28,000 boxes/container
10 boxes/carton
20 pallets of 80 cartons
20 pallets of 60 cartons
40 pallets/container
Pallet size 115 x 104 x 115 cm
and 115 x 104 x 89.5 cm
Pallet weight 500 Kg and 400 Kg
contact [email protected]
www.opulententerprises.com
Nitrile Powder-Free
Examination Gloves 4.0 mil
Product Loading Proposal for 20’DC

Assumptions :
14,000 boxes/container
10 boxes/carton
20 pallets of 80 cartons
20 pallets of 60 cartons
20 pallets/container
Pallet size 115 x 104 x 115 cm
and 115 x 104 x 89.5 cm
Pallet weight 250 Kg and 200 Kg
contact [email protected]

Nitrile Powder-Free www.opulententerprises.com

Examination Gloves 4.0 mil


Current Production Capacity

date month 100 pcs / 1 box


10,000,000
10,000,000
10,000,000
40,000,000
40,000,000
40,000,000
40,000,000
40,000,000

Payment Terms:
The deposit of LC 100% for minimum 10 million boxes per invoice,
LC at sight upon the buyer’s receipt of S.G.S inspection report
and/or other shipping documents accepted by both parties

Representative Structure:

Seller: Chintamonwatchara Group Company Limited


Distributor: Chintamonwatchara Group Company Limited
Marketing Agents: Chintamonwatchara Group Company Limited

Buyer Agents: ____________________________________________


Buyer: ___________________________________________________
contact [email protected]

Nitrile Powder-Free
www.opulententerprises.com

Examination Gloves 4.0 mil


Product Certificate
contact [email protected]

Nitrile Powder-Free
www.opulententerprises.com

Examination Gloves 4.0 mil


Product Certificate
contact [email protected]

Nitrile Powder-Free
www.opulententerprises.com

Examination Gloves 4.0 mil


Product Certificate
contact [email protected]

Nitrile Powder-Free
www.opulententerprises.com

Examination Gloves 4.0 mil


Product Certificate
contact [email protected]

Nitrile Powder-Free
www.opulententerprises.com

Examination Gloves 4.0 mil


Product Certificate
contact [email protected]

Nitrile Powder-Free
www.opulententerprises.com

Examination Gloves 4.0 mil


Product Certificate
contact [email protected]
www.opulententerprises.com

You might also like