®/* Trademarks of Kimberly-Clark Worldwide, Inc., or its affiliates. © 2010 KCWW. Publication code: ID 4561.01 GB 03.10

Da

ta

Pa

ck

KIMTECH PURE* Sterile G3 White Nitrile Gloves

Engineered for Protection. Designed for Comfort.

Vital Process Protection and Comfort of Use

KIMTECH PURE* Sterile G3 White Nitrile Gloves

KIMTECH PURE* Sterile G3 White Nitrile Gloves offer a highly advanced protection of processes, helping you to reduce the risk of contamination.

• Recommended for ISO Class 3 or higher cleanroom environments

• Contain no natural rubber latex reducing the potential for TYPE I glove –associated reactions

• Beaded cuff, for added strength and ease in donning

• Fully textured • Hand specific

• Walleted & pouched in polyethylene for cleanroom use

• Packaged for aseptic donning

• Certificate of Analysis (by Lot) and Certificate of Irradiation available online

• Trend Data available online to demonstrate product quality over time

0123

Whether there is the need for rigid contamination control in the class ISO 3-4 critical environment or class ISO 5-8 controlled environment, KIMBERLY-CLARK PROFESSIONAL* provides a complete line of gloves, masks, apparel and wipers to meet these needs.

All KIMBERLY-CLARK PROFESSIONAL* Products are manufactured to exacting quality standards. Our rigorous process controls ensure every product performs above and beyond the required class or grade for your cleanrooms and clean manufacturing facilities. We continually review our product lines through certification, validation, independent testing and, most importantly, customer satisfaction to ensure your most valuable assets – your processes, your people and your reputation, are protected.

PHYSICAL PROPERTIES (Target values) Characteristics Value Test Method

Freedom from holes 1.5AQL1 ASTM D 5151 and EN374-2 1 AQL as defined per ISO 2859-1 for sampling by attributes

Tensile Properties Tensile Strength Ultimate Elongation- Before Aging 24 MPa, nominal 600% nominal ASTM D 412 and ASTM D 573- After Accelerated Aging 26 MPa, nominal 550% nominal

Dimensional Measured mm Point- Nominal Thickness Middle Finger 0.16 ASTM D 3767 and D 3577 Palm 0.13 Cuff 0.10

Palm Widths- Nominal Width (mm) 6 6.5 7 7.5 8 8.5 9 10 ASTM D 3767 and D 6319 80 87 94 98 109 114 120 128Particles (maximum)- Per cm2 > 0.5 micron 2000 IEST-RP-CC005

Endotoxin (maximum)- Endotoxin Units/pair 20 LAL Kinetic Turbidimetric Method

* Trademark of Kimberly-Clark Worldwide, Inc., or its affiliates.© 2008 KCWW. Publication code: 4410.01 GB 01.08

www.kcprofessional.com

KIMTECH PURE* Sterile G3 White Nitrile Gloves

Size and Code 30cm

10x6 HC611606.5 HC611657 HC611707.5 HC611758 HC611808.5 HC611859 HC6119010 HC61110

20x

Visit our website and discover a brand new concept in cleanroom: the CONTAMINOMICS* Programme –

www.contaminomics.com

KIMTECH PURE* Sterile G3 White Nitrile GlovesFormerly SAFESKIN* Sterile Critical Nitrile Gloves

Product Specifications• Synthetic nitrile1 polymer (Acrylonitrile Butadiene)

• Contains no natural rubber latex. Silicone-free

Quality Standards• This is a PPE Category III product classified by EC Council Directive 89/686/EEC. It is tested in accordance with the EN Norms EN420:2003

• Packaged in a Class 100 Cleanroom

• Meets or exceeds AQL level of 1.5 for pinholes

• Manufactured in accordance with Quality System ISO 9001

1Nitrile is a synthetic material exhibiting many of the properties of natural rubber latex while offering other distinct advantages: comfortable fit, resistance to puncturing and abrasion without compromising dexterity or electrostatic dissipative properties.

INFORMATION SERVICEFor technical enquiries please email infofax@kcc.comFor sales enquiries please email kimtech.support@kcc.com

LATEX-FREE

LOW ENDOTOXIN

PACKAGED FORASEPTIC DONNING

AVAILABLE IN 30CM LENGTH

HAND-SPECIFIC PAIRS

FULLY TEXTURED

KIMTECH PURE*G3 Sterile Nitrile Gloves, 12" Hand-Specific Pair(Formerly SAFESKIN* Sterile Critical Nitrile Gloves)

Catalog Numbers: HC61160, HC61165, HC61170, HC61175, HC61180, HC61185, HC61190, HC61110

Lot #: 440190 Total Cases per Lot: 1949Batches: SM90011XX to SM90311XX Date of Manufacture: Jan-09

Elongation (%) Tensile (MPa)Watertight Dimensions Minor Major Pre Aging Pre Aging

Sample Size: 3087 1488 3087 3087 496 496

AQL Level: 1.5 2.5 4.0 2.5 2.5 2.5

Failures Allowed per AQL: 44 48 162 88 17 17

Failures: 4 0 0 0 0 0Inspection Results: Accept Accept Accept Accept Accept Accept

Averages: 759 22.2Test Methods: Watertight ASTM D 5151, Elongation and Tensile ASTM D 412

Particle Standard AverageSize (µm) Min Max Deviation Particles/cm²0.5 - 1.0 86 551 96 188

Particle Test Data

Certificate of Analysis

Product Description:

Physical Test DataVisual Defects

Size (µm) Min Max Deviation Particles/cm²0.5 - 1.0 86 551 96 1881.0 - 2.0 4 189 27 182.0 - 5.0 1 27 4 5

5.0 - 10.0 0 3 1 110.0 - 20.0 0 1 0 0

>20 0 0 0 0Total per Sample 94 582 103 212

Test Method: IEST-RP-CC005

Fluoride Chloride Nitrite Bromide Nitrate Phosphate SulfateF- Cl- N02

- Br-N03

- P04-3 S04

-2

µg/g glove <0.5 10.0 <2.5 <2.5 4.8 <5 2.0µg/cm2 <0.003 0.076 <0.016 <0.016 0.035 <0.031 0.013

Trace Element ResultsSodium Ammonium Potassium Magnesium Calcium Zinc

Na+NH4

+ K+ Mg+2 Ca+2Zn

µg/g glove 0.9 1.5 1.0 0.3 5.8 1.6µg/cm2 0.006 0.011 0.008 0.002 0.044 0.012

Test Method: IEST-RP-CC005

Test Result: 0.379 Endotoxin Units/device (pair)Specification: < 20 Endotoxin Units/device (pair)

Test Method: Limulus Amebocyte Lysate (LAL) Test: Kinetic Turbidimetric Technique

*Registered Trademark or Trademark of Kimberly-Clark Corporation or its affiliates. Copyright 2001 Kimberly-Clark Corp.

This 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 DataAnions Results

( QA Executive - SSMT )

Endotoxin Data

Cations Results

SA-FORM01193/0

CO

LORS:

Pan

ton

e 267

OU

TER LIN

ER IS:

March

10, 2008 • 583059_003633 jr

06-7

0-0

77-0

-00

NO

TE

: Must com

ply with K

imberly-C

lark Master M

anufacturing Specification - C

orrugated Containers

Inside Dim

ensions:Printer:

Mill:

6” x 12”D

ieline:Flute:

25

2 P

ark

We

st Drive

, Pittsb

urg

h, P

A 1

52

75

te

l 41

2-7

88

-21

11

• fax 4

12

-78

8-0

59

4e

ma

il: pittsb

urg

ha

rt@m

atw

.com

Summary of current validation of Kimtech Pure G3 White Nitrile gloves code numbers: HC61160, HC61165, HC61170, HC61175, HC61180, HC61185, HC61190, HC61110 The study was performed according to the guidelines established by ANSI/AAMI/ISO 11137:2006 "American National Standard, Sterilization of Healthcare Products—Requirements for Validation and Routine Control—Radiation Sterilization." The maximum dose study performed previously established the maximum dose at 50 kGY. The product was tested to be non-bacteriostatic/fungistatic. Three batches of above-referenced gloves were assayed for bioburden levels. Method 1 was used. The overall average was 22.33 CFU/device. No single batch was shown to be more than twice this overall average and therefore this overall average was used to calculate the sub process verification dose. With reference to table 5 of the standard, the nearest value listed equal to or greater than the bioburden level is 24 CFU. Therefore the sub-process dose required for the sterility assurance level of 10 -2 is 6.2 kGy. One hundred units were irradiated at this dose and subsequently individually tested for sterility at 6.2+/-10% kGy. After full incubation period, there were no growths found. Therefore statistical verification is accepted. Referring to Table B.1, to achieve the desired Sterility Assurance Level of 10-6, the minimum dose required is 19.0 kGy. Submitted by:

Ruthlyn M. Reyes KCP Operations Date: December 15, 2009