Our Certifications

CE Type-Examination — Powdered Latex BRI-47173-A (PPE Cat III)
Certified under EU PPE Regulation (EU) 2016/425, Category III
Tested and certified by SATRA Technology Europe (Notified Body 2777)

ISO 13485:2016 confirmation from DQS Certification (M) Sdn Bhd: our Malaysia factory quality management system for non-sterile latex and nitrile examination gloves
Obelis E.A.R. certificate: EU authorized representative appointed (Obelis s.a.) for our Malaysia factory
EU Type-Examination Certificate from SATRA Technology Europe (PPE Regulation (EU) 2016/425, Category III) for BRI-47173-A powdered latex examination gloves, non-sterile

ISO 13485:2016
Medical Devices — Quality Management System

QMS certificate for manufacture and distribution of non-sterile latex and nitrile examination gloves. ISO 13485:2016 is a quality-system standard — not a product CE mark. Certificate available upon request.

Obelis — EU Authorized Representative
Obelis s.a. is our appointed EU authorized representative under MDR (EU) 2017/745. This is an appointment letter only — not a product CE certificate and not “CE MDR certified”.

SATRA EU Type-Examination (BRI-47173-A)

EU Type-Examination Certificate for BRI-47173-A powdered latex examination gloves under PPE Regulation (EU) 2016/425, Category III (SATRA NB 2777). This is our only EU Type-Examination CE — it does not cover nitrile, powder-free latex, or PROTECTOR® antimicrobial. Certificate available upon request.

Commitment to Quality

For product specs from Pacific Resource Global, a latex examination gloves manufacturer in Malaysia, see the latex examination gloves page.

Every pair of Pacific Resource Global gloves is manufactured under strict quality control protocols aligned with international regulatory requirements, ensuring consistent batch-to-batch quality.

Product pages: Latex examination gloves · Nitrile examination gloves · Antimicrobial latex (PROTECTOR®) · US industrial / general-purpose nitrile.

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Raw Material Testing

All incoming raw materials are tested for purity, consistency, and compliance with specifications before production.

In-Process QC

In-process monitoring throughout the dipping, leaching, and vulcanisation processes ensures product integrity.

Physical Testing

Tensile strength, elongation, and barrier integrity tests performed on every production batch.

Final Inspection

Finished products undergo visual inspection, pinhole testing, and packaging verification before dispatch.

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Request Our Certification Documents

We are happy to share ISO 9001 / ISO 13485:2016 QMS certificates, the BRI-47173-A CE Type-Examination (powdered latex PPE Cat III), and the Obelis EU authorized representative appointment with qualified buyers and partners.

Request for Certificates