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Smart Glove Corporation
Sdn. Bhd. has been accredited the highest recognized certification
of ISO 9001: 2000, EN ISO 13485:2003, ISO13485: 2003 by an
SCC accredited CMDCAS registrar, and EC certificate, complying
with Canadian Medical Device Regulation, and FDA Quality System
Regulation (QSR) to ensure consistent glove performance. Our
medical product range allowed to market in the United States
by the FDA through 510(k) process.
All gloves are manufactured
and inspected in strict compliance with Good Manufacturing
Process, surpassing those of the industry standard established
by the American Society for Testing and Material (ASTM), EN
Standard and the most rigid requirement of the FDA. Our gloves
fulfilled CE mark, UL certified according to NFPA 1999-2003
Edition, Standard on Protective Clothing for Emergency Medical
Operations, earning American Dental Association (ADA) Seal
of Acceptance, fulfilled EN Food Contact Regulation 02/72/EC,
Medical Device Directive 93/42/EEC, Personal Protective Equipment
Directive, 89/686/EEC, and Standard Malaysian Glove by Malaysian
Rubber Board.
All gloves are quality
guaranteed and gone through a stringent inspection internally
and independent third party prior to each shipment. It indicates
commitment from Smart Glove to continually exceeding Acceptable
Quality Level (AQL), providing you with maximum barrier protection
and consistently delivery our product that exceed customers'
quality requirements.
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American Dental Association
(ADA) Seal of Acceptance |
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ISO 13485: 2003 |
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ISO9001: 2000 Registration
Number: AR 1741 |
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Food Contact Regulation
2002/72/EC |
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Medical Device License,
Health Canada |
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Canadian Medical Device
Regulation Compliant |
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EN374-2 Resistance to penetration
by microorganisms. Referred to as acceptable
quality level (AQL) |
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UL certified |
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CE Marking |
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U.S. Food and Drug Administration
510(k) Pre-Market Notification For Sale And
Use In USA. |
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EN374-3 Resistance to chemical
hazards (permeation) |
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EN388 Mechanical Hazards
a) Resistance to abrasion b) Blade cut resistance
c) Tear resistance d) Puncture resistance
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Malaysian Rubber Board
Standard Malaysian Glove |
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Certified for use by Australia's
Therapeutic Goods Administration (TGA) |
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Tested for use with Chemotheraphy Gloves |
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