Certification
Assurance of quality & safety with regulatory compliance
Ensuring high-quality, safe, and compliant products that meet industry standards and regulatory requirements.
TÜV SÜD EN ISO 9001
ISO 9001 is an internationally recognized quality management system (QMS) standard that ensures consistent quality and customer satisfaction. TÜV SÜD certification confirms compliance with this standard.
TÜV SÜD EN ISO 13485
ISO 13485 is a standard for medical device quality management systems, ensuring the safety and effectiveness of medical devices. TÜV SÜD certification indicates compliance with regulatory and customer requirements.
FDA CFR 177.2600 – US FOOD CONTACT
This certification indicates compliance with the U.S. Food and Drug Administration (FDA) regulations for food contact materials, ensuring that the product is safe for use in food handling and processing.
EN ISO 21420:2020
This European standard specifies general requirements for protective gloves, including safety, comfort, and performance
EN ISO 374-1:2016 (PPE CAT III)
This certification applies to gloves that provide protection against chemicals and microorganisms. PPE Category III means it is classified as high-risk protective equipment.
UKCA (0120)
The UK Conformity Assessed (UKCA) marking is required for products sold in Great Britain, replacing the CE mark after Brexit. It indicates compliance with UK regulations.
EN 455
EN 455 is a European standard for medical gloves, covering dimensions, physical properties, biological safety, and shelf life to ensure quality and safety for medical applications.
CE (MDR 2017/745)
The CE mark indicates that the product complies with the European Medical Device Regulation (MDR 2017/745), ensuring safety and performance in the EU market.
REACH Compliance-REACH BLACK LIGHT BLUE
REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) is an EU regulation ensuring that chemicals used in products are safe for human health and the environment.
ASTM D6319
ASTM D6319 is a standard specification for nitrile examination gloves used in medical applications, ensuring quality and durability.
Medical Device Authority (Malaysia)
This certification indicates approval by Malaysia’s Medical Device Authority (MDA), ensuring compliance with regulatory requirements for medical devices.
ASTM D3578
ASTM D3578 is a standard specification for rubber examination gloves, primarily used in healthcare settings.
MDSAP (Medical Device Single Audit Program)
The MDSAP allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities, including the US, Canada, Japan, Brazil, and Australia.
Sedex
Sedex (Supplier Ethical Data Exchange) is an ethical trade membership organization that promotes responsible and sustainable business practices in global supply chains.
PROFESSIONAL LATEX SDN BHD (1038089-A)
FACTORY 1
Lot 52, Jalan Logam 2, Kamunting Raya Industrial, 34600,Kamunting, Perak, Malaysia
+605-891 1417
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