Data Pack - Chemicals

1 /* Trademarks of kimberly - clark Worldwide, Inc. or its affiliates. Marques d pos es de kimberly - clark Worldwide, Inc. ou de ses filiales. KCWW 2011. K02306 K6078-11-01 4/11 data PackKIMTECH PURE* G3 Sterile Latex Gloves1 Scientific Products CatalogTable Of COnTenTSTechnical data Sheet Certificate of Analysis (COA) Certificate of Irradiation (COI) Package Label Case Label Sterilization Label Pouch Label Sterilization Validation Study Test Method for Analyzing Liquid Particle Counts Test Method for Analyzing Extractables Test Method for Analyzing Bacterial Endotoxins Glossary of TermsTechNIcAL data : Natural Rubber Latex. : Fifty (50) micrograms or less of total water extractable protein per gram, as measured by ASTM D 5712, Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.

2 Design: 12 in length, Hand Specific, beaded cuff, with textured palm and palm side on : Gamma irradiation. Validated to a Sterility Assurance Level (SAL) of 10-6 according to ANSI/AAMI/ISO : 1 pair/poly pouch, 20 pairs/ double poly bag, 10 double bags (200 pairs) Pure* G3 sterile Natural rubber Latex GlovesProduct Informationcode Formerly Coded description size56843 HC1360S KIMTech Pure* G3 sterile Latex gloves 656844 HC1365S KIMTech Pure* G3 sterile Latex gloves HC1370S KIMTech Pure* G3 sterile Latex gloves 756846 HC1375S KIMTech Pure* G3 sterile Latex gloves HC1380S KIMTech Pure* G3 sterile Latex gloves 856848 HC1385S KIMTech Pure* G3 sterile Latex gloves HC1390S KIMTech Pure* G3 sterile Latex gloves HC1310S KIMTech Pure* G3 sterile Latex gloves /* Trademarks of kimberly - clark Worldwide, Inc.

3 Or its affiliates. Marques d pos es de kimberly - clark Worldwide, Inc. ou de ses filiales. 2010 KCWW. K02067 K4857-10-01 8/10 Formerly SaFeSkin* Sterile Critical natural Rubber Latex GlovesPhysical PropertiescharacteristicsValueTest MethodFreedom from AQL1 ASTM D 51511 AQL as defined per ISO 2859-1 for sampling by attributesTensile PropertiesTensile StrengthUltimate ElongationBefore Aging24 MPa, min. 750%, D 412 and D 573 After Accelerated Aging18 MPa, min. 560%, PointmmmilsNominal ThicknessMiddle D 3767 and D 3577 Nominal Length305mmPalm Width (mm)77838995102108114130 ASTM D 3767 and D 6319 Particles (maximum)Per cm2 micron1500 IEST-RP-CC005endotoxin (maximum)Endotoxin Units/pair20 LAL Kinetic Turbidimetric MethodTotal Protein (maximum)Micrograms/gram50 ASTM D 5712 caution: This Product Contains Natural Rubber Latex, Which May Cause Allergic Reactions.

4 Safe Use Of This Glove By Or On Latex Sensitive Individuals Has Not Been Established. Warning: This product should not be worn by, or exposed to, individuals allergic to natural rubber PURE*G3 Sterile Latex gloves , Hand-Specific PairsHC 1360S, HC 1365S, HC 1370S, HC 1375S, HC 1380S, HC 1385S, HC 1390S, HC 1310 SLot # :420410 Total Cases per Lot : 6217 Batches :SM00912XX to SM01202 XXDate of Manufacture : Apr-10 Expiration Date : 2015 -03 Elongation (%)Tensile (MPa)WatertightDimensionsMinorMajorPre AgingPre AgingSample Size :7690166077807780520520 AQL Level Allowed per AQL :192834473072626 Failures :5702300 Inspection Results : Methods : Watertight ASTM D 5151, Elongation and Tensile ASTM D 412 ParticleStandardAverageSize ( m)MinMaxDeviationParticles/cm - - DefectsCERTIFICATE OF ANALYSISP article Test data **Physical Test data ** Product Description :Catalog Numbers - - - - >200000 Total per Sample272862142590 Test Method : g/g glove< < < < g/cm2< < < < Element ResultsSodiumAmmoniumPotassiumMagnesiumC alciumZincNa+NH4+K+Mg+2Ca+2Zn g/g glove< < < g/cm2< Method : :< 20 Test Method : Limulus Amebocyte Lysate (LAL) Test: Kinetic Turbidimetric Technique*Registered Trademark or Trademark of kimberly - clark Corporation or its affiliates.

5 Copyright 2001 kimberly - clark Corp.**Testing performed at final quality inspection gate prior to document is intended for customer use only. Any disclosure, copying, distribution, or other use of this document is strictly prohibited. Review By :Extractable Ion Test data **Anions ResultsCations ResultsEndotoxin data **Endotoxin Units/ device (pair)Endotoxin Units/ device (pair) ( QA Executive - SSMT ) Review By :SA-FORM01193/4 ( QA Executive - SSMT )Package Label0410/SM001012XX2015-030410/SM001012 XX2015-03 Case Label0410/SM001012XX2015-03 Lot #Batch #Code #Family Sterilization LabelIsotron (Malaysia) Sdn Bhd09300 Kuala Ketil (Kedah)Red is exposedBatch No:Cert No:Irradiation Date.

6 Minimum dose(kGy)M2100402022744004/201025462isot ronRed if SterileSterilization Batch NumberSterilization Certificate Number2015-032010-04420410/SM01012 XXHC1390S9 Pouch LabelTest Method for Analyzing Bacterial Endotoxins This test method is used to detect or quantify endotoxins in sterile medical and cleanroom gloves 1. Scope The test method is a kinetic turbidimetric method used to detect or quantify Gram-negative bacteria using Limulus Amoebocyte Lysate (LAL) from horseshoe crab (Limulus polyphemus or Tachypleus tridentatus). The average contaminant concentration will be reported in endotoxin units per device (pair) This procedure is an overview of the kimberly - clark Internal procedure The safe and proper use of gloves is beyond the scope of this test method This test method does not purport to address all of the safety concerns, if any, associated with its use.

7 It is the responsibility of the user of this Test Method to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. 2 Referenced Documents Pharmacopoeia USP 24 NF 19, Second Supplement, Bacterial Endotoxin Test. ASTM D7102-10 Standard Guide for Determination of Endotoxin on Sterile Medical gloves . 3 Apparatus Microplate reader Computer and windows software Hot air oven capable of 250C Refrigerator capable of 5C Freezer capable of -10 to -20C Vortex mixer Incubator capable of 180 rpm, 35C Timer Micropipettor: single and 8 channel Laminar flow hood 96 well flat bottom microplate, sterile, non-pyrogenic, individually wrapped Sterile, non-pyrogenic pipette tips Aluminum foil Glass beaker 600 mL, 1000 mL Glass tube Pyrogent -5000 test kit catalog N383 or N384 (BioWhittaker, Inc) Pyrogenic-free water 4 Test Preparation.

8 All glassware used for assay must be depyrogenated in a hot air oven at temperature 250C for 2 hours All surface areas must be cleaned with 70% ethyl alcohol solution Glove Sample preparation: Transfer 10 gloves into a 600 or 1000 mL beaker and add 400 mL of pyrogen-free water (only exterior of the gloves are soaked with water) Cover beaker with pyrogen-free aluminum foil and place in incubator shaker at 180 rpm, for 60 minutes at 35C After extraction is completed take the beakers outs, discard the gloves from the solution. Store the test solution at 2-8C Perform dilution of test solution as necessary for testing Reagent, standard endotoxin stock and CSE preparation: LAL reagent (lysate): allow reconstitution buffer to warm to room temperature before use Reconstitute lysate with reconstitution buffer as per test kit instruction Swirl gently to avoid foaming Standard Endotoxin stock solution: Reconstitute endotoxin with specified volume to pyrogen-free water Shake vigorously for 15 min at high speed on a vortex mixer.

9 Control standard endotoxin (CSE): Prepare the CSE per manufacturer s instruction. Prepare serial dilutions (4) as necessary LAL Testing Carefully dispense 100 uL pyrogenic-free water (blank or negative control), positive control, 4 concentrations of CSE and diluted test solution into microtiter wells of microplate. Bubbles must be avoided Place filler plate into microtiter reader (ensure temperature is at 37C) When the assay is finished, print standard curve results and calculate results vs. the standard. Glossary of TermsItemDefinitionAnionThe ion in an electrolyzed solution that migrates to the anode when voltage is generated; broadly: a negatively charged ion.

10 Typical examples include Chloride (Cl-), Phosphate (PO4-3), Sulfate (SO4-2), Nitrate (NO3-).AQLA cceptable Quality Level. Applies to product attributes and defines the allowable number of defects for various sample sizes. For example, AQL means that the sample must demonstrate that it exceeds defects in order to reject the Society of Testing and Materials. The ASTM issues testing standards and specifications. The FDA utilizes many of the standards developed by the ASTM to establish medical device sum of individual observations divided by the total number of observations. Average represents the central tendency of a sample group. The sample group can be used to make inferences about the entire is the population of viable microorganisms on a raw material, component, a finished product and/or a package.