FAQs PPE – Technical Compliance – Surgical Gloves – Sterile

FAQs PPE – Technical Compliance To Relevant Performance Standards For Surgical Gloves – 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 Rubber Examination GlovesASTM D3577Type 1 (natural)               
Type 2 (synthetic)               
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 D3577

AQL < 1.5               
Water tightness testEN 455-1AQL < 1.5               
Water leak/Air leak testEN ISO 374-2
(ISO 2895)
Level 3 AQL <0.65               
Level 2 AQL <1.50               
Level 1 AQL <4.50               
Material strength characteristics 
Tensile strength (before aging)ASTM D3577
(Type 1)
Compliant               
Ultimate elongation (before aging)Compliant               
Stress at 500% elongation (before aging)Compliant               
Tensile strength (after aging)Compliant               
Ultimate elongation (after aging)Compliant               
Tensile strength (before aging)ASTM D3577
(Type 2)
Compliant               
Ultimate elongation (before aging)Compliant               
Stress at 500% elongation (before aging)Compliant               
Tensile strength (after aging)Compliant               
Ultimate elongation (after aging)Compliant               
Breaking force (before aging)EN 455-2Compliant               
Breaking force (after aging)Compliant               
Powder residue 
Powder freeASTM D3577<2.0mg (N=5)               
Powder freeEN 455-3<2.0mg               
PowderedASTM D3577max 10 mg/dm2 (N=2)               
PowderedEN 455-3>2.0mg               
Protein content for allergies 
Aqueous soluble protein contentASTM D3577<200 µg/dm2 (N=3)               
EN 455-3<10 μg protein per g of glove               
Extractable antigenic protein contentASTM D3577<10 µg/dm2 (N=1)               
Size 
Thickness / Length / WidthASTM D3577Compliant               
Compliant               
Compliant               
EN 455Compliant               
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               
Sterility test 
the latest edition of the U.S. PharmacopeiaASTM D3577Compliant               
Sterile barrier integrityEN ISO 11607Compliant               
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