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CAMUI Brochure - July - 2021 - Edition7

The document provides information about Camui Gloves, a company that manufactures powder-free examination gloves. It details Camui's history and partnership with other companies. Product data sheets are included that specify the materials, properties, packaging and regulatory compliance of their nitrile and latex examination gloves.
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0% found this document useful (0 votes)
80 views24 pages

CAMUI Brochure - July - 2021 - Edition7

The document provides information about Camui Gloves, a company that manufactures powder-free examination gloves. It details Camui's history and partnership with other companies. Product data sheets are included that specify the materials, properties, packaging and regulatory compliance of their nitrile and latex examination gloves.
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
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PREVENTION IS BETTER THAN CURE™

Edition:7 July 2021

Patient Polymer Powder free Examination gloves

2/2 Rama 9 Soi 58 Suan Luang Bangkok Thailand 10250 Tel: +6695-935-6600 www.camuithailand.com
Camui Gloves

Camui Thailand Co.,Ltd was first


established in Nagoya, Japan in
2004 and with our initial
business focused on retail sale of
automotive crystal coating and
paint protection equipment in
specialized car detailing centers In
Thailand and Japan.

As a result of the C O V I D - 1 9
crisis in 2020, Camui Thailand
Co., Ltd. made a joint venture
agreement with INTERNATIONAL
HEALTHCARE TRADE LLC., to
utilize their experience in PPE
marketing, sales and export trade
to the United States, namely PPEs
and “Examination Gloves”, to be
manufactured in Thailand.
Camui Gloves

Expert Solutions Quality Assured


CAMUI (THAILAND) CO., LTD has partnered with 9 local brands
and with International Healthcare Trade LLC to facilitate the
introduction of our premium, high quality, fully certified with
FEMA registered line of protective examination gloves.

As a result of the COVID-19 global pandemic it is understood


that there will be shortages of quality personal protective
equipment “PPE” around the world. Camui has decided to
devote investment, time, resources, retail experience and
their global sales network through teaming with a Medical
Glove Company Ltd. a leading manufacturer of Natural
Rubber (NR) and Nitrile Butadiene Rubber (NBR) gloves for
applications in both medical and general-purpose markets.
The core value of the partnership is to provide the best
quality protective products at a fair price to those in need.
The Consortium Glove Companies is the result of a recent
acquisition of a historic market leader in the glove
manufacturing industry. The actual manufacturing plant
located in provinces of Thailand, in the south of Thailand.
commenced our operations by producing latex gloves for
various medical fields. The factory is surrounded by
thousands of acres of rubber tree plantations giving it the
advantage of having the natural latex materials in the vicinity
at hand.
Camui Gloves

Glove Manufacturing Facilities

We use our in-house special formulation in the compounding process.


Our manufacturing facilities are specially designed and built with unique
featuresto produceglovesto meet our customersstringent requirement.
Product Data Sheet – Our Nitrile Examination Glove testedfor use
with Chemotherapy Drugs

1. Device Trade or Proprietary Name: Nitrile Examination Glove Tested For Use with
2. Device Common or Usual Name: Chemotherapy Drugs Examination Glove

3. Device Classification Name: Nitrile Patient Examination Glove (Powder Free)


4. Description of the Device: Non Sterile, Powder-Free, Nitrile Examination for Use with

5. Intended Use of the Device: Chemotherapy This is the disposable device intended for medical
application that is worth examiner’s hand to prevent
contamination between examiner andpatient
protect examiner from the following Chemotherapy drugs tested to
ASTM with the indicated Breakthrough Detection Times :

Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.


Nitrile Powder Free ExaminationGlove Blue
Carmustine (BCNU) 40.00
Cyclophosphamide (Cytoxan) > 240
Doxorubicin HCl (Adriamycin) > 240
Etoposide (Topotar) > 240
Fluorouracil > 240
Paclitaxel (Taxol) > 240
Thio-Tepa 177.00
Cisplatin > 240
Dacarbazine > 240
Thickness min 0.1
mm
Product Data Sheet – Nitrile Powder Free ExaminationGloves

Product Specification Features


Brand CAMUI Thailand Co Ltd ● FingertipTextured
Product Nitrile Examination Glove,Powder Free, Non sterile, Disposable ● Powder Free
● No Natural Latex
Powder Content Maximum 2.0mgper Glove ● Lab ChemicalTested
Protein Content N/A ● Ambidextrous
Size S - 80±10, M - 95±10, L -110±10, XL -115±10 ● Blue color
Avg Width (mm) 100 ±1 0 ● Chlorinated
Avg Weight (g) 3.8 ± 0.3
Length (mm) Min 240 (9") Packaging
Thickness Cuff 0.070 ±0.02 100 or 300 Pieces PerBox
Palm 0.080 ± 0.02 (3.8-4 mil) 10 Boxes per Carton(1,000 Pieces)
Finger 0.110 ±0.02
Physical Properties -ASTM 20FCL -1,300 Cartons(13,000Boxes)
Parameters Tensile (MPa) ElongationBreak (%) Modulus 500%(Mpa) 40FCL -2,600 Cartons(26,000Boxes)
Before Aging 40HQ- 3,200 Cartons(32,000Boxes)
Medella Result 18 650-670 Max 2.8
ASTM Requirement Min 14 Min 650 Max 2.8 Regulatory Compliance
After Aging MDD 93/42/EEC
Medalla Result 16 500-650 Max 2.8 FDA 510K /Class 1
ASTM Requirement Min 14 Min 500 N/A
Physical Properties -EN Standards
Parameters Force Break(N) ElongationBreak (%) ASTM D6319, D6124-06, D6978-05
Before Aging EN ISO374-1:2016
Medalla Result 9-11 N/A EN ISO374-5:2016
ASTM Requirement Min 9 N/A ISO2859-1
After Aging EN 374-4:2013
Medella Result 6-10 N/A EN 420:2003+A1:2009
ASTM Requirement Min 6 N/A EN 388:2016+A1:2018
Performance EN 455-2
Inspection Related Defects Inspection Level AQL
Watertight Test Moles 1.5 ManufacturingAccreditations
Visual Inspection Major Defects G-1 2.5 ISO9001:2015
Minor Defects 4.0 ISO13485:2016
Physical Properties Tensile S-2 4.0 GMP Certified
Physical Dimension Measurement S-2 4.0
Camui 2021 Nitrile Box 6 sides Camui Gloves
Camui 2021 Nitrile Box 6 sides
Camui Latex Gloves

Product Data Sheet – Latex Powder Free Examination Gloves

Cha ra cteristics Ins pecti on Level Accepta bl e QualityLevel Reference Standard


ASTM 5161
Freedom from hol es - Barrier G1 1.5
EN 455-1
● Ma jorVi s ual 2.5
Vi s ua l Defect G1 Indus try Pra cti ce
● Mi norVi s ual 4.0
ASTM D3578
Di mensions S-2 4.0
EN 455-2
ASTM D3578
Phys i ca l Properties S-2 4.0
EN 455-2
ASTM D6124
Ri s i dual PowderContent N= 5 N/A
EN 455-3
N= 3 N/A ASTM D5712
Protei n Content
N= 8 N/A EN 455-3

Phys i ca l Variable Si ze Speci fi cation Limits Reference Standard


Mi n 230 ASTM D3578
Length (mm) Al l s i zes
Mi n 240 EN 455-2
XS 70 ±10
S 80 ±10
ASTM D3578
M 95 ±10
L 111 ± 10
In hous es /
XL 120 ± 10
Pa i rs Wi dth (mm) Cus tomer require
XS ≤ 80
S 90 ±10
M 95 ±10 EN 455-2
L 110 ± 10
XL ≥ 110
Mi d dle Finger0.110 ± 0.02
ASTM D3578
Thi cknes s (mm) Pa l m 0.080 ± 0.02(3.8-4mi l )
Al l s i zes
*s i ngl e wall In hous es /
Cuff 0.070 ± 0.02
Cus tomer require

Specification Limits
Properties
Before Aging After Aging Reference Standard
Elongation atbreak Min 650 Min 800
ASTM D3578
Tensile Strength (MPa) Min 18 Min 14
Force at Break(N) Median 5 Median 6 EN 455-2
ASTM D8124
Residual Powder Content Max 2 mg/g
EN 455-3
Max 200𝜇g/dm^2 ASTM D5712
*Protein Content
N/A EN 455-3
Foreword
Camui Gloves

In the wake of the global pandemic, the suppliers of


PPE around the globe taken on a crucial role to both
keep vital supply chains open and to innovate to deliver
qulity products needed to battle the effects of
the COVID-19 virus.
Today we are proud to present our products made with
uncompromising quality of gloves and personal
protective equipments, made with multiple users in
mind.
CAMUI THAILAND COMPANY Ltd. ( CMT) is upcoming
medical supplier and soon to be the manufacturer and
labeler both Latex and Nitrile Disposible and
Examination Gloves, indetended for General Hospitals,
Medical institutions,
and general usages alike.
All products from CMT following the regulation of
international standards such as FDA, ASTM, TUV ,EN and
ISO. Our products are designed for various users ranging
from medical applications to food grade industries.
AVAILABLE in : LATEX , NITIRLE, and NITRILE BLEND
[ all allergy-free technology ].

"Our mission to be an alternative solution for the against


this life changing pandemic"
CAMUI Facilities

CORPORATE PROFILE
CAMUI THAILAND CO., LTD .

"Your most reliable partner in hand protection safety”.


WHO ARE WE
Camui (Thailand) Company Limited is a newly established medical glove company with
our Head Office in downtown Bangkok, a 40 Rai manufacturing plant located in provinces
of Nontaburi,and another 1200sqm AI Packing Facility in the Bangkok as Our GMP License
Packing Facility Just 20 minutes from the Suvarnabhumi International Airport .
Camui Gloves
M EDICAL MANAGEMENT SYSTEM CERTIFICATION STATUS

1. QUALITY MANAGEMENT SYSTEM CERTIFICATION BYBSI

• ISO 13485: 2016: Certification Number; MD 716521


• ISO 9001: 2015: Certification Number; FM 716518

2. US FDA 510(K): D436519 In application process

3. Enforcment Discretion : Waived for LZA


4. LZA Nitrile Powder Free Examination Gloves Tested For Use with General
Hospitals D436519

• Latex Powder Free Examination glove isin-progress

5.CE and EN TEST

CERTIFICATES

6. EC Type-Exam Certificate
1. EN ISO 21420: 2020
2. EN ISO374-1:2016+A1:2018
3. EN 374-2: 2019
4. EN374-4: 2019
5. EN374-5: 2016
6. EN16523-1: 2015-A1: 2018

• Nitrile Powder Free Examination glove


EU Type-Examination Certificate Number:2777/14960-01/E00-00
• Latex Powder Free Examination glove
EU Type-Examination Certificate Number: 2777/15031-01/E00-00

4. TUV Riehland or Songkhla Medical Sciences Lab Test Reports

• Nitrile Powder Free Examination glove


• Latex Powder Free Examination glove
• EN455-1, EN455-2
Camui AI Proto Type Factory 1
Factory Plan: Nonthaburi Camui Gloves
Certificates
Camui Gloves

Certificates
Camui Gloves

Certificates
Camui Gloves

Certificates
FDA REGISTRATION

Certificates
Camui Gloves

Certificates
OFFICIAL PARTNERS Camui Gloves

LICENSED PARTNERS

Consortium Partners
CAMUI (Thailand) Co Ltd PPE Outlets
Organisation Chart Camui Gloves
Step of Procedure (SOP):

1. NCNDA “CAMUI Nitril Glove”


(signed by all parties)
2. Buyer send the LOI,Passpot of
Authorize person and Company
Profile to Seller
3. Seller send FCO to Buyer
4. Buyer signs, stamps and returns
FCO to Seller With POF
5. Seller prepare actual products
as the sample with copy of FDA,
CE, Allocations and all
Certificates to buyer
6. Buyer issues PO to seller
7. Seller issues SPA and PI, Buyer
signs, stamps and returns SPA & PI
to Seller, schedule of shipment
will show in SPA
8.Buyer vitsit factory and see
actual production line of Nitril
glove.
9. Buyer issues LC according to PI,
Seller verify LC
10. After LC successfully, Seller
start production on Buyer’s order
about 45-60 days
11. After SGS Inspection, Buyer
release LC on shipment
12. Receive product at the
warehouse

***2% penalty of total SPA value


or mutually agree amount if
Buyer/Seller fail to perform

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