K Number

Device Name

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

Manufacturer

KIMBERLY-CLARK CORP.

Date Cleared

2010-09-08

(51 days)

Product Code

LZA LZC

Regulation Number

880.6250

Intended 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), 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* 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 one glove per sterile bouch. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K992062, K992162, K081089, K081027

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical examination glove and the summary describes its material properties and testing against chemotherapy drugs. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It is a barrier device for protection, not a device that applies therapy or treatment.

Diagnostic

The device is described as a "powder-free patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." Its purpose is protective, not diagnostic.

SaMD (Software as a Medical Device)

The device described is a physical medical device (examination gloves) and does not involve any software component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is a "powder-free patient examination glove... worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used for protection during physical examination or handling, not a device used to perform tests on samples taken from the human body.
Device Description: The description details the physical characteristics of the gloves (material, length, color, packaging) and mentions testing for resistance to chemotherapy drugs. This further reinforces its function as a protective barrier.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health
- Using reagents or assays

The testing for chemotherapy drug resistance is a performance characteristic related to its protective function in a specific medical setting, not an indication that it is used for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

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

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

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

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

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

Product codes

LZA, LZC

Device Description

Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Gloves 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. 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:
Dimensions: Meets ASTM Requirements per ASTM D 6319-00a
Physical Properties: Meets ASTM Requirements per ASTM D 6319-00a
Freedom from pinholes: Meets ASTM Requirements per ASTM D 6319-00a, ASTM D 5151-06
Powder Free (Powder Content): Meets ASTM Requirements per ASTM D 6319-00a, ASTM D 6124-06
ISO Skin Irritation Study and Sensitization: Meets ASTM Requirements per ISO 10993, Part 10
ISO Cytotoxicity Study: Meets ASTM Requirements per ISO 10993, Part 5
Resistance to Permeation: Meets ASTM Requirements per ASTM D 6978-05 and/or ASTM F 739-07

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K992062, K992162, K081089, K081027

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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 Corporation
1400 Holcomb Bridge Road
Roswell, GA 30097
Contact Person:	Lester F. Padilla
Tel. No.: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free
Exam 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):

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 | Applicable
Recognized Standards | FDA- | 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 and
Sensitization | 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.

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 Corporation
1400 Holcomb Bridge Road
Roswell, GA 30097
Contact Person:	Lester F. Padilla
Tel. No.: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam
Gloves - 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):

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.

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 | 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 6319-00a
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 |

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.

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 Corporation
1400 Holcomb Bridge Road
Roswell, GA 30097
Contact Person:	Lester F. Padilla
Tel. No.: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam
Gloves - 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):

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	FDA-	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
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

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.

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 Corporation
1400 Holcomb Bridge Road
Roswell, GA 30097
Contact Person:	Lester F. Padilla
Tel. No .: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE-XTRA* Sterile Powder-Free
Exam 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):

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.

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

Non-Clinical Testing:

| Characteristics | Applicable
FDA-
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 6319-00a
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 | ASTM D 6978-05 and/or
ASTM F 739-07 | Meets ASTM Requirements
See 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.

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 Corporation
1400 Holcomb Bridge Road
Roswell, GA 30097
Contact Person:	Lester F. Padilla
Tel. No .: 678-352-6766
Trade/Proprietary Name(s):	Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam
Gloves (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):

. ..

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.

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

Non-Clinical Testing:

| Characteristics | Applicable
FDA-
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 6319-00a
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 Cytotoxicity Study | ISO 10993, Part 10
ISO 10993, Part 5 | Meets ASTM Requirements |
| Resistance to Permeation | ASTM D 6978-05 and/or
ASTM F 739-07 | Meets ASTM Requirements
See 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.

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.

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.

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 | Applicable
FDA- 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 6319-00a
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 | ASTM D 6978-05 and/or
ASTM F 739-07 | Meets ASTM Requirements
See 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.

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.

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.

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

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:

. . . .

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

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

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

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

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

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

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

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