II Surgical Mask (non-fluid repellent)
Disposable II surgical masks
– sterile
– non-sterile
Standards
- CE-marked, self-certified as conforming to to PPE directive EU 2016/425 and EN 14683:2019
- ISO 9001:2015 (Quality Management System), certified by Universal GmbH
- ISO 13485:2016 (Medical Devices Management System), certified by Staunchly Management & System Services Ltd
- ISO 22716:2007 (Good Manufacturing Practices), certified by Artena Quality Systems
- OHSAS 18001:2007 (Occupational Health & Safety Management System)
Sterilisation by Gamma Pak Sterilisation, documentation available.
NHS Requirements
Covered by PPE directive EU 2016/425, EN 14683:2019
Specifications
One size
Previous
Next
IIR Surgical Mask
Disposable IIR surgical masks
– sterile
– non-sterile
Standards
- CE-marked, self-certified as IIR conforming to to PPE directive EU 2016/425 and EN 14683:2019 with test results
- ISO 9001:2015 (Quality Management System), certified by Universal GmbH
- ISO 13485:2016 (Medical Devices Management System), certified by Staunchly Management & System Services Ltd
- ISO 22716:2007 (Good Manufacturing Practices), certified by Artena Quality Systems
- OHSAS 18001:2007 (Occupational Health & Safety Management System)
Sterilisation by Gamma Pak Sterilisation, documentation available.
NHS Requirements
Covered by PPE directive EU 2016/425, EN 14683:2019
Specifications
One size
