FAQs PPE – Technical Compliance – Examination Gloves – Non-sterile

FAQs PPE – Technical Compliance To Relevant Performance Standards For Examination Gloves – Non-sterile

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Standard Test TitleReference StandardMinimum acceptable performance levelCompliant  Claimed performance (Class, Type, or measured)Year/Version of standardReference document (.pdf)
   YESNo   
Test report origin 
ILAC accredited labISO 17025Compliant               
National Notifying BodyISO 17025Compliant               
Local, non-accreditedISO 17025Compliant               
Whole glove performance
Standard Specification for Nitrile Examination Gloves for Medical ApplicationASTM D6319Compliant               
Terminology and performance requirements for chemical risksEN ISO 374-1Type A               
Type B               
Type C               
Determination of resistance to penetrationEN ISO 374-2Compliant               
Determination of resistance to degradation by chemicalsEN ISO 374-4Compliant               
Terminology and performance requirements for micro-organisms risksEN ISO 374-5Compliant               
Medical gloves for single use – Part 1: Requirements and testing for freedom from holesEN 455-1Compliant               
Medical gloves for single use – Part 2: Requirements and testing for physical propertiesEN 455-2Compliant               
Medical gloves for single use – Part 3: Requirements and testing for biological evaluationEN 455-3Compliant               
Medical gloves for single use – Part 4: Requirements and testing for shelf life determinationEN 455-4Compliant               
Penetration/ Freedom from holes
Water testASTM D6319
(ASTM D5151)
AQL < 2.5, G1               
Water tightness testEN 455-1AQL < 1.5               
Water leak/Air leak testEN ISO 374-2
(ISO 2895)
Level 3 AQL <0.65, G1               
Level 2 AQL <1.50, G1               
Level 1 AQL <4.50, S4               
Material strength characteristics
Tensile strength (before aging)ASTM D6319>14MPa AQL<4.0, S2               
Tensile strength (after aging)>14MPa AQL<4.0, S2               
Elongation (before aging)>500%   AQL<4.0, S2               
Elongation (after aging)>400%   AQL<4.0, S2               
Breaking force (before aging)EN 455-2>6.0N               
Breaking force (after aging)>6.0N               
Powder residue
Powder freeASTM D6319<2.0mg (N=5)               
Powder freeEN 455-3<2.0mg               
PowderedASTM D6319max 10 mg/dm2 (N=2)               
PowderedEN 455-3>2.0mg               
Size
ThicknessASTM D6319Finger >0.05mm AQL<4.0, S2               
Palm >0.05mm AQL<4.0, S2               
EN 455N/A                 
LengthEN 455-2
(all sizes)
l≥ 240mm               
ASTM D6319
(xs,s and 6-7)
l≥ 220mm AQL<4.0,S2               
ASTM D6319
(uni,m,l and 7.5-9)
l≥ 230mm AQL<4.0,S2               
Chemical Resistance
Penetration resistance to viralASTM F1671Compliant               
Permeation by continuous contactASTM F739Compliant               
Permeation by intermittent contactASTM F1383Compliant               
Human Repeat Insult Patch Testing – AllergensASTM D6355Compliant               
Resistance to Chemotherapy DrugsASTM D6978Compliant               
Primary skin irritationISO 10993Compliant               
Skin sensitizationISO 10993Compliant               
Other
shelf life*  5 years               
Quality compliance
General quality management systemISO 9001Compliant               
Medical device quality managementISO 13485Compliant               
Sampling procedures for inspection by attribute, post shipmentISO 2859Compliant               
Regulatory clearance
EU PPE Regulation 2016/425 Valid, issued <5 years               
EN MD Directive 93/42/EEC Valid, issued <5 years               
US FDA 510(k) Valid, issued <5 years               
NMPA, export Valid, issued <5 years               
NMPA, internal Valid, issued <5 years