High-performance medical PPE for UK dental clinics and healthcare professionals. Nitrile examination gloves and Type IIR face masks — CE marked under the EU Medical Device Regulation (MDR) 2017/745 as Class I.
Single-use · Non-sterile · Class I MDR
Conformity & Legislation
Applicable standards (DoC): EN ISO 14971:2019, EN ISO 15223-1:2021, EN ISO 20417:2021, EN ISO 10993-1:2020, EN ISO 10993-5:2009, EN ISO 10993-10:2013.
Intended use: Single-use disposable gloves worn on the examiner’s hand to prevent contamination between patient and examiner / transmission of diseases to patients and healthcare personnel. Non-sterile.
3-Ply · Fluid resistant · Single-use · Class I MDR
Conformity & Legislation
Applicable standards (DoC): EN ISO 14971:2019, EN ISO 15223-1:2021, EN ISO 20417:2021, EN ISO 10993-1:2020, EN ISO 10993-5:2009, EN ISO 10993-10:2023, EN ISO 10993-23:2021, EN 14683:2019+AC:2019 Type IIR.
Intended use: Face masks for use in medical institutions or public places to protect users from the spread of microorganisms, body fluids and particulate matter; protect against body fluids, blood spatter or splash during examination and treatment; reduce potential contact with blood and body fluids. Single-use, non-sterile.
Manufacturer
As declared under MDR
Single Registration Number (SRN): CN-MF-000032266
Full manufacturer details and certificates supplied with every order.
EU Authorised Representative
SUNGO Cert GmbH
SRN: DE-AR-000010869
Düsseldorf, Germany
All products are CE marked under Regulation (EU) 2017/745 (MDR) as Class I medical devices. Full EU Declaration of Conformity, technical documentation and batch certificates are available on request. For the UK market, additional MHRA registration and UK Responsible Person (UKRP) requirements apply.
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