United States
Certificates

Quality Management

We pay particular attention to the specifications of our products to ensure that they meet the exact requirements of our customers and all relevant regulations.

We can only achieve total customer satisfaction by meeting those requirements and do so by the rigorous implementation and maintenance of fully certified Quality Management Systems in the UK and at our manufacturing facility in Malaysia. Our operations in both countries are certified by SGS UK Ltd - a certification company of world renown which holds the regulatory status of Notified Body for the manufacture of medical and personal protective equipment in accordance with European and other National regulations.

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ISO 9001:2008 Nitritex Ltd.

Manufacture and supply of latex, polyurethane and vinyl patient examination gloves and sterile latex and nitrile (including neoprene/nitrile) surgical gloves. Supply of surgical facemasks, supply of Cleanroom and protective garments and gloves, supply of Cleanroom consumables and accessories.

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ISO 13485:2003 Nitritex Ltd.

Manufacture and supply of latex, polyurethane and vinyl patient examination gloves and sterile latex and nitrile (including neoprene/nitrile) surgical gloves. Supply of surgical facemasks.

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Directive 93/42/EEC on medical devices, Annex V Nitritex Ltd.

Annex V
Latex and nitrile (including neoprene/nitrile) surgical gloves.

Annex V (sterility aspects only)
Sterile Latex, Nitrile and Co-Polymer Blend Examination Gloves.

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ISO 13485:2003 Nitritex (M) Sdn. Bhd.

Manufacture and Supply of Sterile and Non-Sterile Latex, Nitrile, Vinyl and Co-Polymer Blend Gloves for Surgical & Patient Examination Purposes.

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ISO 13485:2003 Nitritex Ltd. (for Canada)

Manufacture and supply of latex, polyurethane and vinyl patient examination gloves and sterile latex and nitrile (including neoprene/nitrile) surgical gloves. Supply of surgical facemasks.

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ISO 9001:2008 Nitritex (M) Sdn. Bhd.

Manufacture and Supply of Sterile and Non-Sterile Latex, Nitrile, Vinyl and Co-Polymer Blend Gloves for Surgical, Patient Examination, Cleanroom Application and Chemical Protection. Processing and Packing of Sterile and Non-Sterile Cleanroom Consumables.

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Directive 93/42/EEC on medical devices, Annex V Nitritex (M) Sdn. Bhd.

Annex V
Sterile Latex, Nitrile and Co-Polymer Blend Surgical Gloves.

Annex V (sterility aspects only)
Sterile Latex, Nitrile and Co-Polymer Blend Examination Gloves.

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89/686/EEC, Article 11b Nitritex(M) Sdn. Bhd.

Manufacture of Sterile & Non-Sterile Latex, Nitrile and Co-Polymer Blend Gloves for Chemical Protection.

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NEBB Certification of Compliance Nitritex (M) Sdn. Bhd.

As per requirement of ISO 14644-1 the designated area listed have met the respective acceptance criteria. Testing was performed as outlined in the above standard and the results are attested to it in the Report No.: 023/CR~02/2012

Changing Room: ISO Class 6
Cartoning Room: ISO Class 7
Clean Corridor 2: ISO Class 5
Packing Room 2: ISO Class 5
Clean Corridor 1: ISO Class 4
Packing Room 1: ISO Class 4

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Nitritex QMS BS EN ISO 14001

The approved environmental management systems apply to the following:- Suppliers of Specialist Protection Products for Clean Room, Medical and Industrial Applications.

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