Kimberly-Clark Corporation 9 92012

1 Kimberly-Clark Corporation MAR 9 92012 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE nitrile * Powder-Free Exam gloves " LengthSection 5 -51 0(k) SummaryPreparation Date: February 14, 2012 kimberly clark CorporationApplicant: 1400 Holcomb Bridge RoadRoswell, GA 30097 Contat Peson:Lester F. PadillaContat Peson:Tel. No.: 678-352-6766 Trade/Proprietary Name(s): Kimberly-Clark PURPLE nitrile * Powder-Free Exam gloves Name(s): Powder-Free Nititle Patient Examination GloveClassficaion ame:Patient Examination Glove (21 CFR Part ),Polymer Patient Examination Glove (Product Code LZA)Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:1.

2 K102032: Kimberly-Clark PURPLE nitrile XTRA* Sterile Powder-Free Exam gloves (Testedfor Use with Chemotherapy Drugs -12" Pairs); Kimberly-Clark PURPLE NITRILEt SterilePowder-Free Exam Glove (Tested for Use with Chemotherapy Drugs " Pairs); Kimberly-Clark PURPLE nitrile * Sterile Powder-Free Exam Glove (Tested for Use with ChemotherapyDrugs " Singles); Kimberly-Clark PURPLE nitrile XTRA* Sterile Powder-Free ExamGloves (12" Pairs); Kimberly-Clark PURPLE nitrile * Powder-Free Exam Glove ( " Singles);2. K1 015696: Kimberly-Clark PURPLE nitrile * Powder-Free Exam gloves (Chemotherapy gloves -12"1; Kimberly-Clark PURPLE nitrile * Powder-Free Exam Glove (Chemotherapy gloves "); Kimberly-Clark PURPLE nitrile XTRA* Powder-Free Exam gloves (12"); kimberly -ClarkPURPLE nitrile * Powder-Free Exam Glove ( ").)

3 Device Description(s): Kimberly-Clark PURPLE nitrile * Powder-Free Exam gloves are long, non-sterile, purple-colored nitrile , powder-free, ambidextrous patient examination glove that meets the specifications ofASTM D 6319-10, Standard Specification for nitrile Examination gloves for Medical Use(s):A powder-free patient examination glove is a disposable device intended for medical purposes that isworn on the examiners hand or finger to prevent contamination between patient and of Technologies:The technological characteristics (design, specification, performance) of the Subject Devices and thePredicate Devices are substantially 6 -510O(k) SummaryPage 1 of 2 kimberly -Oark Corporation k11qTraditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE nitrile * Powder-Free Exam gloves " LengthNon-Clinical Testing.

4 Characteristics Applicable FDA- Performance ResultsRecognized StandardsDimensions ASTM 0 6319-10 Meets ASTM Requirements_Physical Properties ASTM D 6319-10 Meets ASTM Requirements_Freedom from pinholes ASTM D 6319-10 Met S Rqimns_____ ASTM D 5151-06 MetASMR qimnsPowder Free (Powder Content) ASTM 0 6319-10 et SMRqieetASTM D 6124-06 MetASMR qimnsISO Skin Irritation Study and ISO 10993, Part 10 Sensitization Meets ASTMV RequirementsISO Systemic Toxicity Study ISO 10993, Part 11 Clinical Testing:No Clinical testing was required to determine substantial equivalence of these :The results of the non-clinical testing demonstrate that the gloves meet the FDA-recognized consensusstandards and are substantially equivalent to the predicate 8 -510(k) SummaryPage 2 of 2IL/1 3VY2S Kimberly-Clark CorporationTraditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE nitrile -XTRA* Powder-Free Exam gloves -12" LengthSection 5 -510(k) SummaryPreparation Date: February 14, 2012 kimberly clark CorporationApplicant.

5 1400 Holcomb Bridge RoadRoswell, GA 30097 Contat Peson:Lester F. PadillaContat No.: 678-352-6766 Trad/PrpriearyNames): Kimberly-Clark PURPLE NlTRlLE-XTRA* Powder-Free ExamTradl~rpriearyNames): gloves -12" LengthCommon Name(s): Powder-Free nitrile Patient Examination GlovesClassficaion ame:Patient Examination Glove (21 CFR Part ),Polymer Patient Examination Glove (Product Code LZA)Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:1 .K(102032: Kimberly-Clark PURPLE nitrile XTRA* Sterile Powder-Free Exam gloves (Testedfor Use with Chemotherapy Drugs -12' Pairs); Kimberly-Clark PURPLE nitrile * SterilePowder-Free Exam Glove (Tested for Use with Chemotherapy Drugs " Pairs); Kimberly-Clark PURPLE nitrile * Sterile Powder-Free Exam Glove (Tested for Use with ChemotherapyDrugs " Singles); Kimbely-Clarkc PURPLE nitrile XTRA* Sterile Powder-Free ExamGloves (12' Pairs); Kimberly-Clark PURPLE nitrile * Powder-Free Exam Glove ( " Singles);2.

6 K(101596: Kimberly-Clark PURPLE nitrile * Powder-Free Exam gloves (Chemotherapy gloves -12"); Kimberly-Clark PURPLE nitrile * Powder-Free Exam Glove (Chemotherapy gloves '); Kimberly-Clark PURPLE nitrile XTRA* Powder-Free Exam gloves (12"); kimberly -ClarkPURPLE nitrile * Powder-Free Exam Glove ( ");Device Description(s): Kimberly-Clark PURPLE nitrile -XTRA* Powder-Free Exam gloves are 12-inch long, non-sterile, purple-colored nitrite, powder-free, ambidextrous patient examination glove that meets the specifications ofASTM D 6319-10, Standard Specification for nitrile Examination gloves for Medical Use(s):A powder-free patient examination glove is a disposable device intended for medical purposes that isworn on the examiner's hand or finger to prevent contamination between patient and of Technologies.)

7 The technological characteristics (design, specification, performance) of the Subject Devices and thePredicate Devices are substantially 5 -510O(k) SummaryPage 1 of 2 kimberly -Oark Corporation /)jq2 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE nitrile -XTRA* Powder-Free Exam gloves -12" LengthNon-Clinical Testing:Characteristics Applicable FDA- Performance ResultsRecognized StandardsDimensions ASTMV D 6319-10 Meets ASTM RequirementsPhysical Properties ASTM D 6319-10 Meets ASTM RequirementsFreedom from pinholes ASTM D 6319-10 Met S Rqimns_____ ASTM D 51 51-06 MetASMR qimnsPowder Free (Powder Content) ASTMV D 6319- 10 Met SI RqimnsASTMV D 6124-06 MetASMR qimnsISO Skin Initation Study and ISO 10993, Part 10 Sensitization Meets ASTM RequirementsISO Systemic Toxicity Study ISO 10993, Part 11 Clinical Testing.

8 No Clinical testing was required to determine substantial equivalence of these :The results of the non-clinical testing demonstrate that the gloves meet the FDA-recognized consensusstandards and are substantially equivalent to the predicate 5 -51 0(k) SummaryPage 2 of 2k- /3V2_3 SKimberly- clark CorporationTraditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE nitrile -XTRA* Powder-Free Exam gloves (12")Tested for Use with Chemotherapy DrugsSection 5 -510(k) SummaryPreparation Date: February 14, 2012 kimberly clark CorporationApplicant: 1400 Holcomb Bridge RoadRoswell, GA 30097 Contat Peson:Lester F.

9 PadillaContat No.: 678-352-6766 Trad/PrpriearyNames): Kimberly-Clark PURPLE NlTRlLE-XTRA* Powder-Free ExamTradl~rpriearyNames): gloves -12' LengthCommo Nam~s):Powder-Free nitrile Patient Examination Glove -Tested for UseCommo Nam~s):with Chemotherapy ame:Patient Examination Glove (21 CFR Part ),Patient Examination Glove, Specialty (Product Code LZC)Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:1 .K102032: Kimberly-Clark PURPLE nitrile XTRA* Sterile Powder-Free Exam gloves (Testedfor Use with Chemotherapy Drugs -12" Pairs); Kimberly-Clark PURPLE nitrile * SterilePowder-Free Exam Glove (Tested for Use with Chemotherapy Drugs " Pairs); Kimberly-Clark PURPLE nitrile * Sterile Powder-Free Exam Glove (Tested for Use with ChemotherapyDrugs " Singles); Kimberly-Clark PURPLE nitrile XTRA* Sterile Powder-Free ExamGloves (12' Pairs); Kimberly-Clark PURPLE nitrile * Powder-Free Exam Glove ( " Singles);2.

10 K101596: Kimberly-Clark PURPLE nitrile XTRA* Powder-Free Exam gloves (Tested for Usewith Chemotherapy Drugs -121); Kimberly-Clark PURPLE nitrile * Powder-Free Exam Glove(Tested for Use with Chemotherapy Drugs '); Kimberly-Clark PURPLE nitrile XTRA*Powder-Free Exam gloves (12'); Kimberly-Clark PURPLE nitrile * Powder-Free Exam Glove( );Device Description(s): Kimberly-Clark PURPLE nitrile -XTRAt Powder-Free Exam gloves are 12-inch long, non-sterile, purple-colored nitrile , powder-free, ambidextrous patient examination glove that meets the specifications ofASTM D 6319-10, Standar