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Henan Tongwei Medical Equipment Co., LtdCall us : +86 − −19139704654 // Email us : [email protected]
Henan Tongwei Medical Equipment Co., LtdCall us : +86 − −19139704654 // Email us : [email protected]
Currently powdered medical gloves should comply with the newly established ASTM (American Society of Testing and Materials) limits on powder levels as specified in ASTM D3577 and ASTM D3578 for surgical and examination gloves respectively: Surgical gloves should have no more than 15mg/dm2 (15 milligrams per square decimeter)
Apr 18 2016What exactly does ASTM do? ASTM has come a long way from creating standards for steel in the railroad industry Today ASTM develops and publishes technical standards for many different industries with the goal of enhancing performance and safety over a wide range of products materials systems and services
Aug 20 2019ASTM D3577 – 09(2015) Link to Active This link will always route to the current Active version of the standard ASTM D – 09 Set of requirements to be satisfied please see the full standard for complete details No other units of measurement are included in this standard
Major medical examination glove standards →European standards on medical gloves for single use EN 455-1:2000 Freedom from holes EN 455-2:2009 Physical properties EN 455-3:2006 Biological evaluation EN 455-4:2009 Shelf life determination →ASTM D 3578:2005 Standard specification for rubber examination gloves
ASTM Standards D471 Test Method for Rubber PropertyEffect of Liquids D3577 Specification for Rubber Surgical Gloves D3578 Specification for Rubber Examination Gloves D3767 Practice for Rubber--Measurement of Dimensions D5250 Specification for Poly(vinyl chloride) Gloves for Medical
Leachable Protein No natural rubber latex proteins Thickness (per ASTM D3577 = 0 10 mm) Finger Tip 0 25 mm Cuff 0 16 mm Cuff Length (per EN455-2 = 270 mm size 7 5) 300 mm Force Break Before Accelerated Aging (per EN455-2 = 9 N) Meets/Exceeds Force Break After Accelerated Aging (per EN455-2 = 9 N 7 days 70C in an oven) Meets/Exceeds
Quality Standards *Conforms to ASTM D3577 and EN 455 Standards *Manufactured under QSR (GMP) ISO 9001:2008 ISO 13485:2003 (Medical Device) Quality Management System *Sterilized by Gamma Ray / EtO *Bioburden and sterility tested Glove sizes *5 5 6 0 6 5 7 0 7 5 8 0 8 5 9 0 *Marked in the check box on the shipping carton with black ink
Standard Specification for Rubber Examination Gloves: ASTM D3577: Type 1 (natural) ☐ ☐ Type 2 (synthetic) ☐ ☐ Terminology and performance requirements for chemical risks: EN ISO 374-1: Type A ☐ ☐ Type B ☐ ☐ Type C ☐ ☐ Determination of resistance to penetration: EN ISO 374-2
Aug 20 2019ASTM D3577 – 09(2015) Link to Active This link will always route to the current Active version of the standard ASTM D – 09 Set of requirements to be satisfied please see the full standard for complete details No other units of measurement are included in this standard
1 3 The following safety hazards caveat pertains only to the test method portion Section 8 of this specification: This standard does not purport to address all of the safety concerns if any associated with its use It is the responsibility of the user of this standard to establish appropriate safety health and environmental practices and determine the applicability of regulatory
Sep 10 2020This specification covers certain requirements for packaged sterile rubber surgical gloves of the natural rubber latex type Type 1 and of the synthetic rubber latex type Type 2 ASTM asym not e3577 any warranty express or implied or make any representation that the contents of this abstract are accurate complete or up to date
AS/NZS 4179 ASTM D3577 ASTM D5151-06 ASTM D6124 ASTM D6978-05 ASTM D7102 ASTM F1671 EN455 part 1 2 3 MANUFACTURING ACCREDITATIONS ISO 9001 ISO 13485 EN ISO 13485 Victor Polyisoprene Surgical Gloves Powder Free Outer Glove LATEX 2 0123 GloveOn Victor Outer Glove Before Aging 16 0 1053 1 2 Inspection Level G1 S2 S2 S4 S4 N = 5 N = 20 N
rubber latex protein allergens • Neu-Thera emollient coating protects restores moisturizes and soothes your skin during wear • Surface Modification Technology (SMT) — a proprietary manufacturing technique that delivers a smooth finish for a light feel and smooth grip • Strength and flexibility exceed the ASTM D3577 and EN 455-2
Quality Standards *Conforms to ASTM D3577 and EN 455 Standards *Manufactured under QSR (GMP) ISO 9001:2008 ISO 13485:2003 (Medical Device) Quality Management System *Sterilized by Gamma Ray / EtO *Bioburden and sterility tested Glove sizes *5 5 6 0 6 5 7 0 7 5 8 0 8 5 9 0 *Marked in the check box on the shipping carton with black ink
Sep 26 2019ASTM-D | Standard Specification for Rubber Surgical Gloves | Document Center Inc The gloves shall be manufactured from any rubber polymer compound with the inside and outside surfaces of the gloves free of talc and with dimensions and physical properties that shall conform to the requirements specified
Major medical examination glove standards →European standards on medical gloves for single use EN 455-1:2000 Freedom from holes EN 455-2:2009 Physical properties EN 455-3:2006 Biological evaluation EN 455-4:2009 Shelf life determination →ASTM D 3578:2005 Standard specification for rubber examination gloves
Aug 20 2019ASTM D3577 – 09(2015) Link to Active This link will always route to the current Active version of the standard ASTM D – 09 Set of requirements to be satisfied please see the full standard for complete details No other units of measurement are included in this standard
Referenced ASTM Standards The documents listed below are referenced within the subject standard but are not provided as part of the standard D412 Test Methods for Vulcanized Rubber and Thermoplastic ElastomersTension D573 Test Method for RubberDeterioration in an Air Oven D3767 Practice for Rubber--Measurement of Dimensions D5151 Test Method for Detection of Holes in Medical Gloves
May 01 2018As an importer of latex/rubber medical devices sooner or later you will be likely to experience US FDA Detention at Port of Entry When this occurs ARDL can help you ASTM D3577 ASTM D6977 BS EN 374-2 ASTM D3578 ASTM D6978 BS EN 374-3 ASTM D5151 ASTM D7246 BS EN 455-1 -2 ASTM D5250 ASTM D7329 BS EN 455-3 ASTM D6124 ASTM D7558 ASTM D6319
Jan 23 2020Medical and cleanroom gloves made of latex vinyl and nitrile are the subject of various test standards ASTM D3577 and ISO 11193-1 cover rubber surgical gloves D3578 covers rubber examination gloves but each draws upon ASTM D412 for defining the method for tensile testing
Leachable Protein No natural rubber latex proteins Thickness (per ASTM D3577 ≥ 0 10 mm) Finger Tip 0 25 mm Cuff 0 16 mm Cuff Length (per EN455-2 ≥ 270 mm size 7 5) 300 mm Force Break Before Accelerated Aging (per EN455-2 ≥ 9 N) Meets/Exceeds Force Break After Accelerated Aging (per EN455-2 ≥ 9 N 7 days 70C in an oven) Meets/Exceeds
How to perform ASTM D3577 Medical Elastomer Rubber Glove Test Posted by Debbi Cohen on Fri Jul 16 2010 Tweet In the ASTM acceptance standard for testing rubber surgical gloves (D3577) and rubber medical gloves (D3578) made of latex vinyl and nitrile The standard describes the standard size material properties physical and mechanical
(per ASTM D3577 ≥ 750%) Meets/Exceeds Elongation Break After Accelerated Aging (per ASTM D3577 ≥ 560% 7 days 70C in an oven) Meets/Exceeds Freedom from Holes (per EN 455 AQL 1 5) 0 65 AQL Final Inspection Viral Penetration Tested and passed in accordance with ASTM
Sep 10 2020This specification covers certain requirements for packaged sterile rubber surgical gloves of the natural rubber latex type Type 1 and of the synthetic rubber latex type Type 2 ASTM asym not e3577 any warranty express or implied or make any representation that the contents of this abstract are accurate complete or up to date
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