Personal Protective Equipment

PRODUCT NAMEDESCRIPTIONSPECIFICATION NUMBERSTANDARDS TESTED AGAINSTEnquire
Face maskFFP2 (DTCX3)IPG/005EU Directives 89/686/EEC
EB149:2001+A1:2009
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Face MaskN95 (DTCX3)IPG/005aFDA Approved
NIOSH Approved
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Face MaskN95 SQ100CVbIPG/010FDA Approved
NIOSH Approved		Enquire
Face MaskKN95 / FFP2IPG/012Approved German Authority
Technical Efficiency EU 2020/403 13/03/20 on conformity assessments and market surveillance procedure in the context of the COVID-19 risk
EN 149:2001+A1:2009
EN1374-7:2008
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Face ShieldFace Shield (PET)IPG/006Medical Device Directives Class 1
ISO EN 1497:2012
ISO EN 15223-1:2016
EN 1041:2013
EN 166:2001
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GownNon-SurgicalIPG/007Medical Device Directives 93/42/EEC Class 1Enquire
Nitrile GlovesType C, Nitrile GlovesIPG/001374-1:2003,
EN372-2:2003
EN374-3:2003
EN42:2003 +A1.2009
EN374-2:2014
EN16523-1:2015:
EN374-4:2013
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Nitrile GlovesType C, Nitrile GlovesIPG/002EN374-1:2003
EN420:2003+A1:2009
EN455-1:2000
EN455-2:2015
EN455-3:2015 Clause 4.4 &4.6
Annex II of PPE Regs 2016/425 cat III		Enquire
Surgical Face MaskNon-Woven 3 ply Type IIR (Blue)IPG/004/4aMedical Device Directives 93/42/EEC
Annex V
EN 14683:2014 Annex B
FDA Approved
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Surgical Face MaskNon-Woven 3 ply Type IIRIPG/008EN 14683:2019 + AC:2019(E) Annex B
EN14683:2019 +AC:2019(E) Annex C
EN 14683:2019+AC:2019(E) Annex D
ISO 22609:2004
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Surgical Face MaskNon-Woven 3 ply Type IIRIPG/011Medical Device directives 93/42/EEC Class 1 Annex VII
EN ISO 13485:2016
EN 14683:2019+AC:2019(E) Annex B, Annex C & Annex D
ISO 22609:2004
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SanitiserHand Sanitiser
75% Alcohol 100ml		IPG/013WHO Regulated Formula
Approved in UK by way of Critical Situation Permit
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Sampling SwabsSterile Disposable Sampling SwabsIPG/014Medical Device Directive 93/42/EEC Annex V
IVD MD Directive 98/79/EC
NOT Annext II and NOT self test
EN ISO 15223-1:2012
EN 1041:2008
EN ISO 14971:2009
Module A
Gamma Sterilisation
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COVID 19 Antibody Test KitAntibody Testing KitIPG/003
MD420		In vitro diagnostics Medical Device Directives 98/79/EC
EN ISO 13485:2016
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COVID 19 Antibody Test Kit2019-Novel Coronavirus (2019-nCoV) IgG / IgM Detection Kit (Colloidal Gold- Based)IPG/015
MD422		Invitro Medical Device Directive 98/79/EC Annex III
EN ISO 13485:2016, EN ISO 1497:2012, EN 13975:2003, EN ISO 18113-2:2011, EN ISO 18113-4:2011, EN 13612:2002/AC:2002, EN ISO 17511:2003, EN ISO 15193:2009, EN ISO 15194:200+, EN ISO 23640:2015, EN 13641:2002, EN 1041:2008, ISO 15223-1:2016
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