KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS by KIMBERLY-CLARK CORP.

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:

The following drugs had NO breakthrough detected up to 240 minutes:

Bleomycin sulfate (15.0mg/ml), Busulfan (6.0mg/ml), Carboplatin (10.0mg/ml), Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Cytarabine HCl (100.0mg/ml), Dacarbazine (10 mg/ml), Daunorubicin Hcl (5.0mg/ml), Docetaxel (10.0mg/ml), Doxorubicin HCl (Adriamycin) (2 mg/ml), Ellence (Epirubicin) (2.0mg/ml), Etoposide (20 mg/ml), Fludarabine (25.0mg/ml), Fluorouracil (adrucil) (50 mg/ml), Gemcitabine (38.0mg/ml), Idarubicin (1.0mg/ml), Ifosfamide (50mg/ml), Irinotecan (20.0mg/ml), Mechlorethamine HCl (1.0mg/ml), Melphalan (5.0mg/ml), Methotrexate (25.0mg/ml), Mitomycin (0.5mg/ml), Mitoxantrone (2 mg/ml), Paclitaxel (Taxol) (6 mg/ml), Paraplatin (10.0mg/ml), Rituximab (10.0mg/ml), ThioTEPA (10.0mg/ml), Trisenox (0.1mg/ml), Vincristine Sulfate (1 mg/ml)

Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes

Device Description

Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves are 12-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are packaged as two gloves per sterile pouch.

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves are 9.5-inch long, sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. The gloves are packaged as two gloves per sterile pouch.

Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 12-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." The gloves are packaged as two gloves per sterile pouch.

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the drugs listed in the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." The gloves are packaged as two gloves per sterile pouch.

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." The gloves are packaged as one glove per sterile pouch.

AI/ML Overview

The provided document K102032 describes several types of Kimberly-Clark PURPLE NITRILE Sterile Powder-Free Exam Gloves. The acceptance criteria and the study proving the device meets these criteria are detailed in the "Non-Clinical Testing" sections for each bundled device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The devices are patient examination gloves, and their acceptance criteria are based on recognized consensus standards, primarily ASTM D 6319-00a (Standard Specification for Nitrile Examination Gloves for Medical Applications), ASTM D 5151-06 (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D 6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ISO 10993 Part 10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization), ISO 10993 Part 5 (Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity), and for chemotherapy gloves, ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) and/or ASTM F 739-07 (Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact).

All listed devices report that their performance "Meets ASTM Requirements" or "Meets ASTM Requirements - See Intended Use Section" for "Resistance to Permeation".

Characteristics	Applicable Recognized Standards	Reported Device Performance
Dimensions	ASTM D 6319-00a	Meets ASTM Requirements
Physical Properties	ASTM D 6319-00a	Meets ASTM Requirements
Freedom from pinholes	ASTM D 6319-00a, ASTM D 5151-06	Meets ASTM Requirements
Powder Free (Powder Content)	ASTM D 6319-00a, ASTM D 6124-06	Meets ASTM Requirements
ISO Skin Irritation Study and Sensitization	ISO 10993, Part 10	Meets ASTM Requirements
ISO Cytotoxicity Study	ISO 10993, Part 5	Meets ASTM Requirements
Resistance to Permeation (for Chemotherapy Gloves only)	ASTM D 6978-05 and/or ASTM F 739-07	Meets ASTM Requirements (and specific drug permeation data are detailed in the Intended Use sections)

2. Sample size used for the test set and the data provenance:

The documents do not specify the exact sample sizes used for each test. The results are reported as meeting the requirements of the standards, implying that the sample sizes used for testing adhered to the specifications of the referenced ASTM and ISO standards.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that these are non-clinical laboratory tests performed to meet recognized international (ISO) and American (ASTM) standards, it's implied that these tests were conducted under controlled laboratory conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

These are non-clinical, performance-based tests against established standards (ASTM, ISO). There is no "ground truth" established by human experts in the way it would be for a diagnostic device. The "ground truth" is defined by the objective metrics and methodologies specified within the standards themselves. Therefore, human experts are involved in conducting and interpreting these standardized tests according to the established protocols, not in establishing subjective ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. As noted above, these are non-clinical, objective performance tests against established standards. There is no subjective interpretation or adjudication by multiple human readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted diagnostic device, but a physical medical device (examination gloves). Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for these tests is the quantitative and qualitative criteria defined within the applicable ASTM and ISO standards. For example, for "Freedom from pinholes," the ground truth is whether or not a glove exhibits pinholes when tested according to ASTM D 5151-06. For "Resistance to Permeation," the ground truth is the measured breakthrough time of specific chemotherapy drugs as per ASTM D6978-05.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established:

Not applicable. As stated above, there is no training set for this type of device.

Summary

{0}------------------------------------------------

K102032

Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves - 12" Pairs

Section 5 - 510(k) Summary

Preparation Date:	July 06, 2010
Applicant:	Kimberly Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30097
Contact Person:	Lester F. PadillaTel. No.: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-FreeExam Gloves - 12" Pairs
Common Name(s):	Powder-Free Nitrile Patient Examination Gloves (Sterile)
Classification Name:	Patient Examination Glove (21 CFR Part 880.6250),Polymer Patient Examination Glove (Product Code LZA)

Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:

3 Kimberly-Clark Corporation

Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 】.
Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
1. Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089
Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove K081027 4.

Device Description(s):

{1}------------------------------------------------

Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves - 12" Pairs

Intended Use(s):

A powder-free pațient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Summary of Technologies:

The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.

Non-Clinical Testing:

Characteristics	ApplicableRecognized Standards	Performance Results
Dimensions	ASTM D 6319-00a	Meets ASTM Requirements
Physical Properties	ASTM D 6319-00a	Meets ASTM Requirements
Freedom from pinholes	ASTM D 6319-00a	Meets ASTM Requirements
	ASTM D 5151-06
Powder Free (Powder Content)	ASTM D 6319-00a	Meets ASTM Requirements
	ASTM D 6124-06
ISO Skin Irritation Study andSensitization	ISO 10993, Part 10	Meets ASTM Requirements
ISO Cytotoxicity Study	ISO 10993, Part 5

Clinical Testing:

No Clinical testing was required to determine substantial equivalence of these devices.

Conclusion:

The results of the non-dinical testing demonstrate that the gloves meet the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.

{2}------------------------------------------------

Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves - 9.5" Pairs

Preparation Date:	July 06, 2010
Applicant:	Kimberly Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30097
Contact Person:	Lester F. PadillaTel. No.: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free ExamGloves - 9.5" Pairs
Common Name(s):	Powder-Free Nitrile Patient Examination Glove (Sterile)
Classification Name:	Patient Examination Glove (21 CFR Part 880.6250),Polymer Patient Examination Glove (Product Code LZA)

Section 5 - 510(k) Summary

Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:

Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 1.
Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
1. Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089
1. Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove - K081027

Device Description(s):

{3}------------------------------------------------

Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves - 9.5" Pairs

Intended Use(s):

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Summary of Technologies:

The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.

Non-Clinical Testing:

Characteristics	ApplicableRecognized Standards	Performance Results
Dimensions	ASTM D 6319-00a	Meets ASTM Requirements
Physical Properties	ASTM D 6319-00a	Meets ASTM Requirements
Freedom from pinholes	ASTM D 6319-00aASTM D 5151-06	Meets ASTM Requirements
Powder Free (Powder Content)	ASTM D 6319-00aASTM D 6124-06	Meets ASTM Requirements
ISO Skin Irritation Study and Sensitization	ISO 10993, Part 10	Meets ASTM Requirements
ISO Cytotoxicity Study	ISO 10993, Part 5	Meets ASTM Requirements

Clinical Testing:

No Clinical testing was required to determine substantial equivalence of these devices.

Conclusion:

The results of the non-clinical testing demonstrate that the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.

{4}------------------------------------------------

Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves - 9.5 Singles

Preparation Date:	July 06, 2010
Applicant:	Kimberly Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30097
Contact Person:	Lester F. PadillaTel. No.: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free ExamGloves - 9.5" Singles
Common Name(s):	Powder-Free Nitrile Patient Examination Glove (Sterile)
Classification Name:	Patient Examination Glove (21 CFR Part 880.6250),Polymer Patient Examination Glove (Product Code LZA)

Section 5 - 510(k) Summary

Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:

Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 1.
Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug 3. Use Claim - K081089
1. Kimberly-Clark Sterile Sterling Nitrile Powder-Free Exam Glove - K081027

Device Description(s):

{5}------------------------------------------------

Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves - 9.5 Singles

Intended Use(s):

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Summary of Technologies:

The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.

Non-Clinical Testing:

Characteristics	Applicable Recognized Standards	Performance Results
Dimensions	ASTM D 6319-00a	Meets ASTM Requirements
Physical Properties	ASTM D 6319-00a	Meets ASTM Requirements
Freedom from pinholes	ASTM D 6319-00aASTM D 5151-06	Meets ASTM Requirements
Powder Free (Powder Content)	ASTM D 6319-00aASTM D 6124-06	Meets ASTM Requirements
ISO Skin Irritation Study andSensitization	ISO 10993, Part 10	Meets ASTM Requirements
ISO Cytotoxicity Study	ISO 10993, Part 5

Clinical Testing:

No Clinical testing was required to determine substantial equivalence of these devices.

Conclusion:

The results of the non-clinical testing demonstrate that the gloves meet the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.

{6}------------------------------------------------

K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 12" Pairs

Preparation Date:	August 18, 2010
Applicant:	Kimberly Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30097
Contact Person:	Lester F. PadillaTel. No .: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-FreeExam Gloves (Chemotherapy Glove) - 12" Pairs
Common Name(s):	Powder-Free Nitrile Patient Examination Chemotherapy Use Glove(Sterile)
Classification Name:	Patient Examination Glove (21 CFR Part 880.6250),Patient Examination Glove, Specialty (Product Code LZC)

Section 5 - 510(k) Summary

Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:

1. Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) - K992062
Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
Kimberly-Clark Sterling Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug 3. Use Claim - K081089
Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove K081027 4.

Device Description(s):

{7}------------------------------------------------

K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) – 12" Pairs

Intended Use(s):

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:

The following drugs had NO breakthrough detected up to 240 minutes:

Bleomycin sulfate (15.0mg/ml)	Idarubicin (1.0mg/ml)
Busulfan (6.0mg/ml)	Ifosfamide (50mg/ml)
Carboplatin (10.0mg/ml)	Irinotecan (20.0mg/ml)
Cisplatin (1 mg/ml)	Mechlorethamine HCl (1.0mg/ml)
Cyclophosphamide (20 mg/ml)	Melphalan (5.0mg/ml)
Cytarabine HCl (100.0mg/ml)	Methotrexate (25.0mg/ml)
Dacarbazine (10 mg/ml)	Mitomycin (0.5mg/ml)
Daunorubicin Hcl (5.0mg/ml)	Mitoxantrone (2 mg/ml)
Docetaxel (10.0mg/ml)	Paclitaxel (Taxol) (6 mg/ml)
Doxorubicin HCI (Adriamycin) (2 mg/ml)	Paraplatin (10.0mg/ml)
Ellence (Epirubicin) (2.0mg/ml)	Rituximab (10.0mg/ml)
Etoposide (20 mg/ml)	ThioTEPA (10.0mg/ml)
Fludarabine (25.0mg/ml)	Trisenox (0.1mg/ml)
Fluorouracil (adrucil) (50 mg/ml)	Vincristine Sulfate (1 mg/ml)
Gemcitabine (38.0mg/ml)

Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes

Summary of Technologies:

The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.

{8}------------------------------------------------

K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 12" Pairs

Non-Clinical Testing:

Characteristics	ApplicableFDA-Recognized Standards	Performance Results
Dimensions	ASTM D 6319-00a	Meets ASTM Requirements
Physical Properties	ASTM D 6319-00a	Meets ASTM Requirements
Freedom from pinholes	ASTM D 6319-00aASTM D 5151-06	Meets ASTM Requirements
Powder Free (Powder Content)	ASTM D 6319-00aASTM D 6124-06	Meets ASTM Requirements
ISO Skin Irritation Study andSensitization	ISO 10993, Part 10	Meets ASTM Requirements
ISO Cytotoxicity Study	ISO 10993, Part 5	Meets ASTM Requirements
Resistance to Permeation	ASTM D 6978-05 and/orASTM F 739-07	Meets ASTM RequirementsSee Intended Use Section

Clinical Testing:

No Clinical testing was required to determine substantial equivalence of these devices.

Conclusion:

The results of the non-clinical testing demonstrate that the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in a bold, sans-serif font. The text is black, and the overall design is simple and corporate.

K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Pairs

Preparation Date:	August 18, 2010
Applicant:	Kimberly Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30097
Contact Person:	Lester F. PadillaTel. No .: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free ExamGloves (Chemotherapy Glove) - 9.5" Pairs
Common Name(s):	Powder-Free Nitrile Patient Examination Chemotherapy Use Glove(Sterile)
Classification Name:	Patient Examination Glove (21 CFR Part 880.6250),Patient Examination Glove, Specialty (Product Code LZC)

Section 5 - 510(k) Summary

Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:

Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 1.
Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic 2. Drugs Labeling Claim - K992162
1. Kimberly-Clark Sterling Nitrile & Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089
Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove K081027 4.

Device Description(s):

. ..

{10}------------------------------------------------

K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Pairs

Intended Use(s):

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:

Bleomycin sulfate (15.0mg/ml)	Idarubicin (1.0mg/ml)
Busulfan (6.0mg/ml)	Ifosfamide (50mg/ml)
Carboplatin (10.0mg/ml)	Irinotecan (20.0mg/ml)
Cisplatin (1 mg/ml)	Mechlorethamine HCI (1.0mg/ml)
Cyclophosphamide (20 mg/ml)	Melphalan (5.0mg/ml)
Cytarabine HCl (100.0mg/ml)	Methotrexate (25.0mg/ml)
Dacarbazine (10 mg/ml)	Mitomycin (0.5mg/ml)
Daunorubicin Hcl (5.0mg/ml)	Mitoxantrone (2 mg/ml)
Docetaxel (10.0mg/ml)	Paclitaxel (Taxol) (6 mg/ml)
Doxorubicin HCl (Adriamycin) (2 mg/ml)	Paraplatin (10.0mg/ml)
Ellence (Epirubicin) (2.0mg/ml)	Rituximab (10.0mg/ml)
Etoposide (20 mg/ml)	ThioTEPA (10.0mg/ml)
Fludarabine (25.0mg/ml)	Trisenox (0.1mg/ml)
Fluorouracil (adrucil) (50 mg/ml)	Vincristine Sulfate (1 mg/ml)
Gemcitabine (38.0mg/ml)

The following drugs had NO breakthrough detected up to 240 minutes:

Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes

Summary of Technologies:

The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.

{11}------------------------------------------------

K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Pairs

Non-Clinical Testing:

Characteristics	ApplicableFDA-Recognized Standards	Performance Results
Dimensions	ASTM D 6319-00a	Meets ASTM Requirements
Physical Properties	ASTM D 6319-00a	Meets ASTM Requirements
Freedom from pinholes	ASTM D 6319-00aASTM D 5151-06	Meets ASTM Requirements
Powder Free (Powder Content)	ASTM D 6319-00aASTM D 6124-06	Meets ASTM Requirements
ISO Skin Irritation Study andSensitizationISO Cytotoxicity Study	ISO 10993, Part 10ISO 10993, Part 5	Meets ASTM Requirements
Resistance to Permeation	ASTM D 6978-05 and/orASTM F 739-07	Meets ASTM RequirementsSee Intended Use Section

Clinical Testing:

No Clinical testing was required to determine substantial equivalence of these devices.

Conclusion:

The results of the non-clinical testing demonstrate that the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.

{12}------------------------------------------------

K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Singles

Preparation Date: August 18, 2010 Kimberly Clark Corporation Applicant: 1400 Holcomb Bridge Road Roswell, GA 30097 Lester F. Padilla Contact Person: Tel. No.: 678-352-6766 Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Trade/Proprietary Name(s): Gloves (Chemotherapy Glove) - 9.5" Single Powder-Free Nitrile Patient Examination Chemotherapy Use Glove Common Name(s): (Sterile) Patient Examination Glove (21 CFR Part 880.6250), Classification Name: Patient Examination Glove, Specialty (Product Code LZC)

Section 5 - 510(k) Summary

Legally Marketed Device(s) to Which Substantial Equivalence is Claimed:

Safeskin Sterile PURPLE NITRILE* Examination Gloves (Powder-Free) K992062 l .
1. Safeskin PURPLE* Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim - K992162
Kimberly-Clark Sterling Nitrile Xtra Powder-Free Exam Gloves with Chemotherapy Drug 3. Use Claim - K081089
Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove K081027 4.

Device Description(s):

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, sterile, purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. In addition these gloves were tested for use with the Intended Use(s) section below, per ASTM D6978-05 "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs." The gloves are packaged as one glove per sterile pouch.

{13}------------------------------------------------

K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Singles

Intended Use(s):

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:

The following drugs had NO breakthrough detected up to 240 minutes:

Bleomycin sulfate (15.0mg/ml)	Idarubicin (1.0mg/ml)
Busulfan (6.0mg/ml)	Ifosfamide (50mg/ml)
Carboplatin (10.0mg/ml)	Irinotecan (20.0mg/ml)
Cisplatin (1 mg/ml)	Mechlorethamine HCl (1.0mg/ml)
Cyclophosphamide (20 mg/ml)	Melphalan (5.0mg/ml)
Cytarabine HCl (100.0mg/ml)	Methotrexate (25.0mg/ml)
Dacarbazine (10 mg/ml)	Mitomycin (0.5mg/ml)
Daunorubicin Hcl (5.0mg/ml)	Mitoxantrone (2 mg/ml)
Docetaxel (10.0mg/ml)	Paclitaxel (Taxol) (6 mg/ml)
Doxorubicin HCI (Adriamycin) (2 mg/ml)	Paraplatin (10.0mg/ml)
Ellence (Epirubicin) (2.0mg/ml)	Rituximab (10.0mg/ml)
Etoposide (20 mg/ml)	ThioTEPA (10.0mg/ml)
Fludarabine (25.0mg/ml)	Trisenox (0.1mg/ml)
Fluorouracil (adrucil) (50 mg/ml)	Vincristine Sulfate (1 mg/ml)
Gemcitabine (38.0mg/ml)

Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes

Summary of Technologies:

The technological characteristics (design, specification, performance) of the Subject Devices and the Predicate Devices are substantially equivalent.

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Image /page/14/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in a bold, sans-serif font. The text is all in black, and the logo appears to be a vector graphic.

K102032 Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves (Chemotherapy Glove) - 9.5" Singles

Non-Clinical Testing:

Characteristics	ApplicableFDA- Recognized Standards	Performance Results
Dimensions	ASTM D 6319-00a	Meets ASTM Requirements
Physical Properties	ASTM D 6319-00a	Meets ASTM Requirements
Freedom from pinholes	ASTM D 6319-00aASTM D 5151-06	Meets ASTM Requirements
Powder Free (Powder Content)	ASTM D 6319-00aASTM D 6124-06	Meets ASTM Requirements
ISO Skin Irritation Study andSensitization	ISO 10993, Part 10	Meets ASTM Requirements
ISO Cytotoxicity Study	ISO 10993, Part 5	Meets ASTM Requirements
Resistance to Permeation	ASTM D 6978-05 and/orASTM F 739-07	Meets ASTM RequirementsSee Intended Use Section

Clinical Testing:

No Clinical testing was required to determine substantial equivalence of these devices.

Conclusion:

The results of the non-clinical testing demonstrate that the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of three human figures, represented by flowing lines, symbolizing health and well-being.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Kimberly-Clark Corporation C/O Mr. Ned Divine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

SEP 0 8 2010

Re: K102032

Trade/Device Name: Kimberly-Clark Purple NITRILE-XTRA "Sterile Powder-Free

Examination Glove with Tested For Use with Chemotherapy Drug Labeling Claim (12"Pairs)

Labeling Claim (12"Pairs).

Kimberly-Clark Purple NITRILE Sterile Powder-Free Examination Glove with Tested For Use with Chemotherapy Labeling Claim (9.5"Pairs)

Kimberly-Clark Purple NITRILE Sterile Powder Free Examination Glove with Tested For Use with Chemotherapy Drug Labeling Claim (9.5"Single)

Kimberly-Clark Purple NITRILE-XTRA Sterile Powder-Free Examination Glove (12"Pairs)

Kimberly-Clark Purple NITRILE Sterile Powder-Free Examination Glove (9.5"Pairs)

Kimberly-Clark Purple NITRILE Sterile Powder-Free Examination Glove (9.5"Single)

Regulation Number: 21 CFR 880.6250

Regulation Name: Patient Examination Glove

Regulatory Class: I

Product Code: LZA, LZC .

Dated: August 18, 2010

Received: August 20, 2010

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act.

{16}------------------------------------------------

Page 2- Mr. Devine

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting; (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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Page 3- Mr. Devine

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

(-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-{-

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{18}------------------------------------------------

Indications for Use

510(k) Number (if known): K102032

Device Name(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12" Pairs

Indications for Use:

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:

The following drugs had NO breakthrough detected up to 240 minutes:

Bleomycin sulfate (15.0mg/ml)	Idarubicin (1.0mg/ml)
Busulfan (6.0mg/ml)	Ifosfamide (50mg/ml)
Carboplatin (10.0mg/ml)	Irinotecan (20.0mg/ml)
Cisplatin (1 mg/ml)	Mechlorethamine HCl (1.0mg/ml)
Cyclophosphamide (20 mg/ml)	Melphalan (5.0mg/ml)
Cytarabine HCl (100.0mg/ml)	Methotrexate (25.0mg/ml)
Dacarbazine (10 mg/ml)	Mitomycin (0.5mg/ml)
Daunorubicin Hcl (5.0mg/ml)	Mitoxantrone (2 mg/ml)
Docetaxel (10.0mg/ml)	Paclitaxel (Taxol) (6 mg/ml)
Doxorubicin HCl (Adriamycin) (2 mg/ml)	Paraplatin (10.0mg/ml)
Ellence (Epirubicin) (2.0mg/ml)	Rituximab (10.0mg/ml)
Etoposide (20 mg/ml)	ThioTEPA (10.0mg/ml)
Fludarabine (25.0mg/ml)	Trisenox (0.1mg/ml)
Fluorouracil (adrucil) (50 mg/ml)	Vincristine Sulfate (1 mg/ml)
Gemcitabine (38.0mg/ml)

Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes

Page 1 of 2
Elizabeth St. Claire-Will

(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

. . . .

{19}------------------------------------------------

Indications for Use (cont'd)

510(k) Number (if known): K102032

Device Name(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Glove (Chemotherapy Glove) – 12" Sterile Pairs

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K | O2032

{20}------------------------------------------------

Indications for Use

510(k) Number (if known): K102032

Device Name(s):

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 9.5" Pairs

Indications for Use:

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:

The following drugs had NO breakthrough detected up to 240 minutes:

Bleomycin sulfate (15.0mg/ml)	Idarubicin (1.0mg/ml)
Busulfan (6.0mg/ml)	Ifosfamide (50mg/ml)
Carboplatin (10.0mg/ml)	Irinotecan (20.0mg/ml)
Cisplatin (1 mg/ml)	Mechlorethamine HCl (1.0mg/ml)
Cyclophosphamide (20 mg/ml)	Melphalan (5.0mg/ml)
Cytarabine HCl (100.0mg/ml)	Methotrexate (25.0mg/ml)
Dacarbazine (10 mg/ml)	Mitomycin (0.5mg/ml)
Daunorubicin HCl (5.0mg/ml)	Mitoxantrone (2 mg/ml)
Docetaxel (10.0mg/ml)	Paclitaxel (Taxol) (6 mg/ml)
Doxorubicin HCl (Adriamycin) (2 mg/ml)	Paraplatin (10.0mg/ml)
Ellence (Epirubicin) (2.0mg/ml)	Rituximab (10.0mg/ml)
Etoposide (20 mg/ml)	ThioTEPA (10.0mg/ml)
Fludarabine (25.0mg/ml)	Trisenox (0.1mg/ml)
Fluorouracil (adrucil) (50 mg/ml)	Vincristine Sulfate (1 mg/ml)
Gemcitabine (38.0mg/ml)

Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes

Page 1 of 2
Elita I Clanto-Wille

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K1102032

{21}------------------------------------------------

Indications for Use (cont'd)

510(k) Number (if known): K102032

Device Name(s):

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 9.5" Sterile Pairs

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _K 102032

{22}------------------------------------------------

Indications for Use

510(k) Number (if known): K102032

Device Name(s):

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Chemotherapy Glove) -- 9.5" Singles

Indications for Use:

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05:

The following drugs had NO breakthrough detected up to 240 minutes:

Bleomycin sulfate (15.0mg/ml)	Idarubicin (1.0mg/ml)
Busulfan (6.0mg/ml)	Ifosfamide (50mg/ml)
Carboplatin (10.0mg/ml)	Irinotecan (20.0mg/ml)
Cisplatin (1 mg/ml)	Mechlorethamine HCl (1.0mg/ml)
Cyclophosphamide (20 mg/ml)	Melphalan (5.0mg/ml)
Cytarabine HCl (100.0mg/ml)	Methotrexate (25.0mg/ml)
Dacarbazine (10 mg/ml)	Mitomycin (0.5mg/ml)
Daunorubicin Hcl (5.0mg/ml)	Mitoxantrone (2 mg/ml)
Docetaxel (10.0mg/ml)	Paclitaxel (Taxol) (6 mg/ml)
Doxorubicin HCl (Adriamycin) (2 mg/ml)	Paraplatin (10.0mg/ml)
Ellence (Epirubicin) (2.0mg/ml)	Rituximab (10.0mg/ml)
Etoposide (20 mg/ml)	ThioTEPA (10.0mg/ml)
Fludarabine (25.0mg/ml)	Trisenox (0.1mg/ml)
Fluorouracil (adrucil) (50 mg/ml)	Vincristine Sulfate (1 mg/ml)
Gemcitabine (38.0mg/ml)

Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes

Page 1 of 2

Elyatt P. Laurent-Well
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Nur

{23}------------------------------------------------

Image /page/23/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized cross inside, followed by the company name in bold, sans-serif font. The text is black, and the overall design is simple and corporate.

Indications for Use (cont'd)

510(k) Number (if known): K102032

Device Name(s):

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 9.5" Sterile Single

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2_

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _ K/62032

{24}------------------------------------------------

Indications for Use

510(k) Number (if known): K102032

Device Name(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free Exam Glove (12" Pairs)

Indications for Use:

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Elijabeth P. Claveria-Wilber

(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Reviens Division of Antool, Dental Devices

510(k) Number: K102032

{25}------------------------------------------------

ද්‍යා Kimberly-Clark Corporation

Indications for Use

510(k) Number (if known): K | 02032

Device Name(s):

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (9.5" Pairs)

Indications for Use:

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 (Division Sign-Off)

(Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K70 2032

{26}------------------------------------------------

Image /page/26/Picture/0 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a stylized symbol to the left of the company name. The text "Kimberly-Clark Corporation" is written in a bold, sans-serif font, with "Kimberly-Clark" being larger than "Corporation". The overall design is simple and professional.

Indications for Use

510(k) Number (if known): K | 02032

Device Name(s):

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (9.5" Singles)

Indications for Use:

A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Edith P. Clauss-Willis

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102032

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.