KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-

K101596 · Kimberly-Clark · LZC · Jul 21, 2010 · General Hospital

Device Facts

• Record ID: K101596
• Device Name: KIMBERLY-CLARK PURPLE NITRILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) AND KIMBERLY-CLARK PURPLE NITRILE XTRA POWDER-
• Applicant: Kimberly-Clark
• Product Code: LZC · General Hospital
• Decision Date: Jul 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

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: [List of drugs provided in document]. Warning - Not for Use with Carmustine and ThioTEPA.

Device Story

Disposable, non-sterile, ambidextrous, powder-free nitrile examination gloves; available in 9.5-inch (PURPLE NITRILE) and 12-inch (PURPLE NITRILE-XTRA) lengths. Used by healthcare professionals in clinical settings to provide a barrier against contamination. Chemotherapy-rated variants tested per ASTM D6978-05 for permeation resistance against a specific list of chemotherapy agents; not for use with Carmustine or ThioTEPA. Gloves function as a physical barrier; no active components or software.

Clinical Evidence

No clinical testing was required to determine substantial equivalence. Evidence is based on non-clinical bench testing, including ASTM D6319-00a, ASTM D5151-06, ASTM D6124-06, ASTM D6978-05, and ISO 10993 (cytotoxicity, skin irritation, and sensitization).

Technological Characteristics

Material: Nitrile. Design: Ambidextrous, powder-free, non-sterile. Lengths: 9.5-inch and 12-inch. Standards: ASTM D6319-00a (physical/dimensional), ASTM D5151-06 (pinholes), ASTM D6124-06 (powder content), ASTM D6978-05 (chemotherapy permeation), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization).

Indications for Use

Indicated for use as a disposable patient examination glove worn by clinicians to prevent cross-contamination between patient and examiner. Chemotherapy-specific versions are indicated for use during handling of specific chemotherapy drugs (excluding Carmustine and ThioTEPA).

Regulatory Classification

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.

Predicate Devices

• Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim (K992162)
• Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves with Chemotherapy Drug Use Claim (K081089)
• Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove (K081260)

Submission Summary (Full Text)

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

K101596

# JUL 2-1 2010

Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy)

| Preparation Date: | 30 June 2010 |
|----------------------------|-------------------------------------------------------------------------------------|
| Applicant: | Kimberly Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30097 |
| Contact Person: | Lester F. Padilla<br>Tel. No.: 678-352-6766 |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam<br>Gloves (Chemotherapy Glove) |
| Common Name(s): | Powder-Free Nitrile Patient Examination Chemotherapy Use Gloves |
| Classification Name: | Patient Examination Glove, Specialty (21 CFR Part 880.6250 -<br>Product Code LZC) |

#### Section 5 - 510(k) Summary

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

- 1. Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim - K992162
- Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves 2. with Chemotherapy Drug Use Claim - K081089
- 3. Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove K081260

#### Device Description(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy Glove) are 12inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, 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."

#### 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 palient and examiner.

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

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

### Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy)

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

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

The following drugs showed breakthrough detected in less than 30 minutes:

| Carmustine (3.3mg/ml): 1.8 minutes<br> ThioTEPA (10.0mg/ml): 1.7 minutes<br>Comments of the control a province a desire a desire a de control a de control a province a formation a formation and consideration and consideration of the formation of the |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

### Warning - Not for Use with Carmustine and ThioTEPA

#### Summary of Technologies:

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

#### Non-Clinical Testing (Subject Device):

| Characteristics | Applicable FDA-<br>Recognized Standards | Performance Results |
|------------------------------------------------|-----------------------------------------|---------------------------------------------------------------------|
| Dimensions | ASTM D6319-00a | Meets ASTM Requirements |
| Physical Properties | ASTM D6319-00a | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D6319-00a<br>ASTM D5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D6319-00a<br>ASTM D6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | Meets ASTM Requirements |
| Resistance to Permeation | ASTM D6978-05 and/or<br>ASTM F739-07 | Meets ASTM Requirements<br>See Intended Use Section for<br>Device 1 |

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

Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy)

K101596

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

# 101596

### ഇടി Kimberly-Clark Corporation

#### Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy)

#### 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.

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

# 101596

## ලිපු Kimberly-Clark Corporation

#### Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy)

| Preparation Date: | 30 June 2010 |
|----------------------------|-----------------------------------------------------------------------------------|
| Applicant: | Kimberly Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30097 |
| Contact Person: | Lester F. Padilla<br>Tel. No.: 678-352-6766 |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves<br>(Chemotherapy Glove) |
| Common Name(s): | Powder-Free Nitrile Patient Examination Chemotherapy Use Gloves |
| Classification Name: | Patient Examination Glove, Specialty (21 CFR Part 880.6250 -<br>Product Code LZC) |

#### Section 5 - 510(k) Summary

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

- Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs 1 . Labeling Claim - K992162
- Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves 2. with Chemotherapy Drug Use Claim - K081089
- 3. Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove K081260

#### Device Description(s):

Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Glove) are 9.5-inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, 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."

#### 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:

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

### Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy)

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

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

The following drugs showed breakthrough detected in less than 30 minutes:

| Carmustine (3.3mg/ml): 1.8 minutes | ThioTEPA (10.0mg/ml): 1.7 minutes |
|------------------------------------|-----------------------------------|
|------------------------------------|-----------------------------------|

#### Warning - Not for Use with Carmustine and ThioTEPA

#### Summary of Technologies:

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

#### Non-Clinical Testing (Subject Device):

| Characteristics | Applicable FDA-<br>Recognized Standards | Performance Results |
|------------------------------------------------|-----------------------------------------|-----------------------------------------------------|
| Dimensions | ASTM D6319-00a | Meets ASTM Requirements |
| Physical Properties | ASTM D6319-00a | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D6319-00a<br>ASTM D5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D6319-00a<br>ASTM D6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Cytotoxicity Study | ISO 10993, Part 5 | |
| Resistance to Permeation | ASTM D6978-05 and/or<br>ASTM F 739-07 | Meets ASTM Requirements<br>See Intended Use Section |

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

# K101596

## ്‍ട്ടി Kimberly-Clark Corporation

#### Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy)

#### 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 FDA-recognized consensus standards and are substantially equivalent to the predicate devices.

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

#### Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves

| Preparation Date: | 30 June 2010 |
|----------------------------|--------------------------------------------------------------------------------|
| Applicant: | Kimberly Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30097 |
| Contact Person: | Lester F. Padilla<br>Tel. No.: 678-352-6766 |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves |
| Common Name(s): | Powder-Free Nitrile Patient Examination Gloves |
| Classification Name: | Polymer Patient Examination Glove (21 CFR Part 880.6250 -<br>Product Code LZA) |

#### Section 5 - 510(k) Summary

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

- 1. Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim - K992162
- 2. Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves with Chemotherapy Drug Use Claim - K081089
- 3. Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove - K081260

#### Device Description(s):

Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves are 9.5-inch long, non-sterile purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 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.

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

#### Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves

#### Non-Clinical Testing (Subject Device):

| Characteristics | Applicable FDA-<br>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<br>ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-00a<br>ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>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.

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

### Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves

| Preparation Date: | 30 June 2010 |
|----------------------------|--------------------------------------------------------------------------------|
| Applicant: | Kimberly Clark Corporation<br>1400 Holcomb Bridge Road<br>Roswell, GA 30097 |
| Contact Person: | Lester F. Padilla<br>Tel. No.: 678-352-6766 |
| Trade/Proprietary Name(s): | Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam<br>Gloves |
| Common Name(s): | Powder-Free Nitrile Patient Examination Gloves |
| Classification Name: | Polymer Patient Examination Glove (21 CFR Part 880.6250 -<br>Product Code LZA) |

#### Section 5 - 510(k) Summary

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

- Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs 1. Labeling Claim - K992162
- Kimberly-Clark STERLING* Nitrile & STERLING* NITRILE-XTRA* Powder-Free Exam Gloves 2. with Chemotherapy Drug Use Claim - K081089
- 3. Kimberly-Clark LAVENDER* Nitrile Powder-Free Examination Glove K081260

#### Device Description(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile purple-colored nitrile, powder-free, ambidextrous patient examination glove that meets all of the requirements of ASTM D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.

#### 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.

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

### Traditional 510(k) Notification: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves

#### Non-Clinical Testing (Subject Device):

| Characteristics | Applicable FDA-<br>Recognized Standards | Performance Results |
|--------------------------------------------------------------------------|-----------------------------------------|-------------------------|
| Dimensions | ASTM D6319-00a | Meets ASTM Requirements |
| Physical Properties | ASTM D6319-00a | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D6319-00a<br>ASTM D5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D6319-00a<br>ASTM D6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization<br>ISO Cytotoxicity Study | ISO 10993, Part 10<br>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 gloves meet the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.

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

Image /page/11/Picture/0 description: The image shows a partial view of the seal for the Department of Health & Human Services. The seal includes the department's name around the perimeter and a stylized caduceus symbol in the center. The caduceus is depicted with a staff and intertwined snakes, representing medicine and healing. The image is in black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

JUL 21 2010

Re: K101596

Trade/Device Name: Kimberly -Clark PURPLE NITRILE Powder-Free Exam Glove (Chemotherapy Gloves)

> Kimberly -Clark PURPLE NITRILE -XTRA Powder-Free Exam Glove (Chemotherapy Gloves)

Kimberly -Clark PURPLE NITRILE Powder-Free Exam Glove Kimberly -Clark PURPLE NITRILE -XTRA * Powder-Free Exam Glove

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC, LZA Dated: July 2, 2010 Received: July 6, 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. 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

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

Page 2-Mr. Devine

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.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

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

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

### යි හි Kimberly-Clark Corporation

#### Indications for Use

510(k) Number (if known):

Device Name(s):

Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Gloves)

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

The following drugs showed breakthrough detected in less than 30 minutes:

Carmustine (3.3mg/ml): 1.8 minutes : ThioTEPA (10.0mg/ml): 1.7 minutes

Warning - Not for Use with Carmustine and ThioTEPA

Page 1 of 2

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

510(k) Number: __

{14}------------------------------------------------

### Indications for Use

510(k) Number (if known):

Device Name(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (Chemotherapy Gloves)

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

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

The following drugs showed breakthrough detected in less than 30 minutes:

Carmustine (3.3mg/ml): 1.8 minutes ThioTEPA (10.0mg/ml): 1.7 minutes

Warning - Not for Use with Carmustine and ThioTEPA

Page 1 of 2

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

510(k) Number:

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

#### Indications for Use

510(k) Number (if known):

Device Name(s):

Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves

### 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

signature

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

510(k) Number:

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

### Indications for Use

510(k) Number (if known): K 101596

Device Name(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves

#### 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

(Division Sign-Uff) Division of Anesthesiology. General Hospital Infection Control, Dental Os neas

510(k) Number: |<101596