CAMC International Trading Co., Ltd.  

Product Name: Medical Equipment Disposable Protective/Isolation Gowns Clothing Model NO.: Gowns Medical Devices Reg./Record No.: 20200002 Medical Device Regulatory Type: Type 1 Medical Devices Ad. Approval No.: GB 19082 Logo Printing: Without Logo Printing Group: Adult Quality Guarantee Period: One Year Ethylene Oxide Sterilization: Ethylene Oxide Sterilization Certification: CE, FDA, ISO13485 Material: Non-woven Fabric Type: Disposable Isolation Gown and Cap Colour: White, Yellow, Green, Blue, Pink, Navy Blue, Olive Transport: 10PCS per bag and 100PCS per carton Trademark: Yuanda Transport Package: Carton Specification: Use of breathable SMS non-woven material Origin: China HS Code: 6210109020 Product Description Instructions for use of isolation clothingFabric material: it is made of air permeable SMS non-woven material, which can effectively prevent dust, harmful particles and limited splashing of low-risk liquid.Application place: it is used for general isolation in medical institutions, outpatient clinics, wards, laboratories, etc.Industrial operation: powder spraying, harmful particles and low-risk liquid Limited splash protection use.Typical application fields: isolation clothing is designed to protect people from low hazard substances, and can also protect people from pollution in the production process.Restrictions on use: when exposed to very fine dust, large amount of liquid spray or splashing of harmful substances, it may be necessary to choose better protective clothing than disposable isolation clothing. Do not take any responsibility for improper use of disposable isolation clothing.Preparation before use: although it will not happen in general, do not wear it if the isolation clothing is damaged.Storage: the isolation coat can be stored at 15 ºC (59 ºF) 25 ºC (77 ºF) in a dark place (cardboard box) to avoid ultraviolet radiation.Disposal: isolate garment customers for incineration or control landfill disposal.Disclaimer: the design of the isolation clothing is disposable. Before wearing, the user shall carefully check the overall situation of the isolation clothing, including fabric, zipper, seam, interface, etc., to ensure that the isolation clothing is in good condition and free of damage so as to play a full protective role in the use process. If the medical isolation clothing is damaged during use, the relevant personnel shall immediately return to the safe environment, and thoroughly dispose the isolation clothing according to the requirements, so as to ensure that the employee is suitable for wearing the isolation clothing in the relevant environment.Textile product inspection reportProduct nameIsolation GownModel-Commission enterpriseMa'anshan Yuanda Medical Technology Co., LtdBrand-Address204, No. 15, Hunan Road,Yushan District, Ma'anshan CityTest typeCommissioned sample deliveryProduct enterprise-Sample level safety category-/-Address-Date of arrival2020-02-20Sampling location-Date of inspection2020-02-20---2020-02-24Quantity2Subcontracting-Sampling base / batch-/-Sample statusMeet the inspection requirementsBatch number or article number or item number-Dateof manufacture-Inspection / Judgment basisGB19082-2009 Technical standard for disposable protective clothing for medical use.GB / T 4744-2013 Test and evaluation of water resistance of textiles hydrostatic pressure method,GB / T 12704 1-2009 Test method for moisture permeability of textile fabrics Part I, moisture absorption method,GB / T 4745-2012 Test and evaluation of water resistance of textiles dip method,GB / T 3923 1-2013 Tensile properties of textile fabrics Part I Determination of breaking strength and elongation at break (strip method),GB2626-2006Respiratory protective equipment - self-priming filter type particle respirator.GB / T 5455-2014 Determination of damage length, smoldering and continuous burning time in the vertical direction of the burning performance of textiles. Customer requirements.Test conclusionThe samples meet the requirements of customers after inspection. GB 19082-2009 technical requirements for disposable protective clothing for medical use.Remarks-Serial numberInspection itemsTest methodTechnical requirementTest resultSingle judgement1AppearanceAppearance1Visual inspection, general gauge measurementThe protective clothing shall be dry, clean and free of mildew, and the surface shall be free of adhesion, cracks, holes and other defectsAccord QualifiedAppearance2The connection part of the protective clothing can be processed by sewing, bonding or heat sealing. The distance between stitches shall be 8-14 stitches per 3cm, and the stitches shall be evenAccord Appearance3The zipper of protective clothing with zipper shall not leak outAccord 2StructureComposition requirementsVisual inspection,It's made up of Hoodie and trousersAccordQualifiedStructural requirementsIt can be divided into one-piece structure and one-piece structure,reasonable structure, easy to wear and take off,Tight jointAccord Closure or finger closure requirementsElastic cuffs for cuffs and feet, elastic cuffs for hat face and waistAccord 3Permeation quantity(g/m4·d)GB/T12704.1-2000≥250011200Qualified4Moisture resistanceGB/T4745-2012≥33Qualified5Breaking tensionStraight directionGB/T 3923.1-2013≥45100QualifiedCross direction≥45706Elongation at breakStraight directionGB/T 3923.1-2013≥15108QualifiedCross direction≥151017Flame retardancyDuration of continued combustion(Straight)GB/T 5455-2014 Condition A≥150QualifiedDuration of continued combustion(cross )≥150After-flame time(Straight )≥100Damaged length(Straight )(mm)≤200181Damaged length(cross)(mm)≤200166