Standards


 

 

Certifications


ISO 9001 : 2008 (Brightway, Laglove, Biopro)

Manufacture of Natural (Latex) and Synthetic Latex (Nitrile) Examination, Surgical and Industrial Gloves & Nitrile Sheath

ISO 13485 : 2016, EN ISO 13485 : 2016 (Brightway(Plant 1), Laglove, Biopro)

Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination and Sterile Surgical Gloves

ISO 13485 : 2016 (Brightway (Plant 1), Laglove, Biopro)

Manufacture of Non Sterile Natural (Latex) and Synthetic Latex (Nitrile) Examination and Sterile Surgical Gloves

Directive 93/42/EEC on Medical Devices, Annex V (Brightway)

Natural (Latex) and Synthetic Latex (Nitrile) Surgical Gloves

Directive 93/42/EEC on Medical Devices, Annex V (Laglove)

Natural (Latex) and Synthetic Latex (Nitrile) Surgical Gloves

Directive 93/42/EEC on Medical Devices, Annex V (Biopro)

Natural (Latex) and Synthetic Latex (Nitrile) Surgical Gloves

CMDCAS

Canadian Medical Devices Conformity Assessment System

NextTech Certificate of Compliance (Brightway)

ISO14644 compliance

Regulation (EU)2016/425 (FINAS) (Brightway(Plant 1), Brightway (Plant 2), Laglove, Biopro)

Manufacture of Chemical Protective Latex and Nitrile Gloves.

Regulation (EU)2016/425 (UKAS) (Brightway(Plant 1), Brightway (Plant 2), Laglove, Biopro)

Manufacture of Chemical Protective Latex and Nitrile Gloves.

Medical Device Registration Certificate (Brightway)

Powder Free Nitrile Examination Glove.

Medical Device Registration Certificate (Brightway)

Powder Free Latex Examination Glove .

Medical Device Act2012(ACT 737) Establishment Licence

Manufacturer