KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE

K113423 · Kimberly-Clark Corp. · LZA · Mar 9, 2012 · General Hospital

Device Facts

• Record ID: K113423
• Device Name: KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
• Applicant: Kimberly-Clark Corp.
• Product Code: LZA · General Hospital
• Decision Date: Mar 9, 2012
• 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.

Device Story

Disposable, non-sterile, ambidextrous, powder-free nitrile patient examination gloves. Available in 9.5-inch and 12-inch lengths. Used by healthcare professionals in clinical settings to provide a barrier against contamination between patient and examiner. Specific 12-inch models are tested for resistance to permeation by various chemotherapy drugs per ASTM D6978-05. Gloves are donned manually by the user. Benefit includes protection against cross-contamination and potential exposure to hazardous chemotherapy agents.

Clinical Evidence

No clinical testing was required to determine substantial equivalence. Evidence is based on non-clinical bench testing including dimensions, physical properties, freedom from pinholes, powder content, skin irritation/sensitization (ISO 10993-10), systemic toxicity (ISO 10993-11), and chemotherapy drug permeation resistance (ASTM D6978-05).

Technological Characteristics

Nitrile polymer construction; powder-free; ambidextrous; 9.5-inch or 12-inch length. Meets ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application). Chemotherapy-tested models meet ASTM D6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs).

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hand or finger to prevent contamination between patient and examiner. Certain models are indicated for use with specific chemotherapy drugs as tested per ASTM D6978-05.

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

• Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (K102032)
• Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (K101596)

Submission Summary (Full Text)

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K113423

Image /page/0/Picture/1 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized "K" inside, followed by the company name "Kimberly-Clark Corporation" in bold, sans-serif font. The text is in black, and the background is white.

MAR - 9 2012

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

| | | r and the province of the first of the first of the first of the first for the first for the first for the first for the first for the first for the first for the first for t | |
|---|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
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| Preparation Date: | February 14, 2012 |
|----------------------------|-----------------------------------------------------------------------------------------------------------|
| 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>9.5" |
| Common Name(s): | Powder-Free Nitrile Patient Examination Glove |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250),<br>Polymer Patient Examination Glove (Product Code LZA) |

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

- 1. K102032: Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 12" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Singles); Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (12" Pairs); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5" Singles);
- 2. K101596: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Gloves - 12"); Kimberly-Clark PURPLE * Powder-Free Exam Glove (Chemotherapy Gloves -9.5"); Kimberly-Clark PURPLE NITRILE XTRA* Powder-Free Exam Gloves (12"); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9,5"):

### 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 the specifications of ASTM D 6319-10, 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.

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

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

### Non-Clinical Testing:

| Characteristics | Applicable FDA-<br>Recognized Standards | Performance Results |
|------------------------------------------------|-----------------------------------------|-------------------------|
| Dimensions | ASTM D 6319-10 | Meets ASTM Requirements |
| Physical Properties | ASTM D 6319-10 | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D 6319-10<br>ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-10<br>ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | 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.

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

# imberly-Clark Corporation

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

| Preparation Date: | February 14, 2012 |
|----------------------------|-----------------------------------------------------------------------------------------------------------|
| 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 - 12" Length |
| Common Name(s): | Powder-Free Nitrile Patient Examination Gloves |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250),<br>Polymer Patient Examination Glove (Product Code LZA) |

## Section 5 - 510(k) Summary

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

- 1. K102032: Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 12" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Singles); Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (12" Pairs); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5" Singles);
- 2. K101596: Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Gloves (Chemotherapy Gloves - 12"); Kimberly-Clark PURPLE * Powder-Free Exam Glove (Chemotherapy Gloves -9.5"); Kimberly-Clark PURPLE NITRILE XTRA* Powder-Free Exam Gloves (12"); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5");

### Device Description(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, 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 wom 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.

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

# 3 Kimberly-Clark Corporation

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

### Non-Clinical Testing:

| Characteristics | Applicable<br>Recognized Standards | Performance Results |
|-------------------------------------------------------------------------------|------------------------------------------|-------------------------|
| Dimensions | ASTM D 6319-10 | Meets ASTM Requirements |
| Physical Properties | ASTM D 6319-10 | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D 6319-10<br>ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-10<br>ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization<br>ISO Systemic Toxicity Study | ISO 10993, Part 10<br>ISO 10993, Part 11 | 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}------------------------------------------------

-

-- *

# Kimberly-Clark Corporation

:

### Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs

| Preparation Date: | February 14, 2012 |
|----------------------------|--------------------------------------------------------------------------------------------------------------|
| 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 - 12" Length |
| Common Name(s): | Powder-Free Nitrile Patient Examination Glove - Tested for Use<br>with Chemotherapy Drugs. |
| Classification Name: | Patient Examination Glove (21 CFR Part 880.6250),<br>Patient Examination Glove, Specialty (Product Code LZC) |

## Section 5 - 510(k) Summarv

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

- 1. K102032: Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 12" Pairs); Kimberty-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Pairs); Kimberly-Clark PURPLE NITRILE* Sterile Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5" Singles); Kimberly-Clark PURPLE NITRILE XTRA* Sterile Powder-Free Exam Gloves (12" Pairs); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5" Singles);
- 2. K101596: Kimberly-Clark PURPLE NITRILE XTRA* Powder-Free Exam Gloves (Tested for Use with Chemotherapy Drugs - 12"); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (Tested for Use with Chemotherapy Drugs - 9.5"); Kimberly-Clark PURPLE NITRILE XTRA* Powder-Free Exam Gloves (12"); Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove (9.5%):

### Device Description(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves are 12-inch long, non-sterile, purplecolored nitrile, powder-free, ambidextrous patient examination glove that meets the specifications of ASTM D 6319-10, 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."

These gloves meet the 2008 Glove Guidance Manual recommended minimum thickness and length specifications for gloves tested for use with chemotherapy drugs.

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

# (Kimberly-Clark Corporation

### Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs

### Intended Use(s):

A powder-free patient examination glove is a disposable device intended for medical purposes that is wom 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 mg/ml) | Gemcitabine HCI (38.0mg/ml) |
|--------------------------------|---------------------------------|
| Busulfan (6 mg/ml) | Idarubicin HCI (1.0mg/ml) |
| Carboplatin (10 mg/ml) | Ifosfamide (50.0 mg/ml) |
| Cisplatin (1.0 mg/ml) | Irinotecan HCI (20.0 mg/ml) |
| Cyclophosphamide (20.0 mg/ml) | Mechlorethamine HCI (1.0 mg/ml) |
| Cytarabine HCl (100 mg/ml) | Melphalan (5 mg/ml) |
| Dacarbazine (10 mg/ml) | Methotrexate (25 mg/ml) |
| Daunorubicin HCI (5.0 mg/ml) | Mitomycin-C (0.5 mg/ml) |
| Docetaxel (10.0 mg/ml) | Mitoxantrone (2.0 mg/ml) |
| Doxorubicin HCI (2.0 mg/ml) | Paclitaxel (6.0 mg/ml) |
| Epirubicin (Ellence) (2 mg/ml) | Rituximab (10 mg/ml) |
| Etoposide (20.0 mg/ml) | ThioTEPA (10.0 mg/ml) |
| Fludarabine (25 mg/ml) | Trisenox (0.1 mg/ml) |
| Fluorouracil (50.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) |

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

Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 30.7 minutes

### Summary of Technologies:

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

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

# Kimberly-Clark Corporation

### Traditional 510(k) Notification (Bundled): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Gloves (12") Tested for Use with Chemotherapy Drugs

### Non-Clinical Testing:

| Characteristics | Applicable<br>FDA-<br>Recognized Standards | Performance Results |
|------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D 6319-10<br>and<br>2008 FDA Glove<br>Guidance Manual (for<br>thickness and length) | Meets ASTM Requirements<br>and<br>2008 FDA Glove Guidance<br>Manual (for thickness and<br>length) |
| Physical Properties | ASTM D 6319-10 | Meets ASTM Requirements |
| Freedom from pinholes | ASTM D 6319-10<br>ASTM D 5151-06 | Meets ASTM Requirements |
| Powder Free (Powder Content) | ASTM D 6319-10<br>ASTM D 6124-06 | Meets ASTM Requirements |
| ISO Skin Irritation Study and<br>Sensitization | ISO 10993, Part 10 | Meets ASTM Requirements |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | Meets ASTM Requirements |
| Resistance to Permeation | ASTM D 6978-05 and<br>ASTM F 739-07 | Meets ASTM Requirements<br>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 gloves meet the FDA-recognized consensus standards and are substantially equivalent to the predicate devices.

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

Image /page/7/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that suggest the shape of the bird's body and wings.

### 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 Corporation C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062

Re: K113423

Trade/Device Name: Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Glove with Tested for Use with Chemotherapy Drugs Labeling Claim (12" Length)

Kimberly-Clark Purple NITRILE-XTRA* Powder-Free Exam Glove (12" Length)

Kimberly-Clark PURPLE NITRILE* Powder-Free Exam Glove i (9.5" Length)

Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: February 23, 2012

Received: February 24, 2012

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.

MAR - 9 2012

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

Page 2 - Mr. Ned Devine

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.

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,

Anthony

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

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

# ളും Kimberly-Clark Corporation

# Indications for Use

510(k) Number (if known): K113423

Device Name(s):

Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Glove With Tes Te d FOR USE WITH OFFEMOTHERAPY DRUGS LABELING CLAIM - 12" Length 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 mg/ml) | Gemcitabine HCl (38.0mg/ml) |
|--------------------------------|---------------------------------|
| Busulfan (6 mg/ml) | Idarubicin HCl (1.0mg/ml) |
| Carboplatin (10 mg/ml) | Ifosfamide (50.0 mg/ml) |
| Cisplatin (1.0 mg/ml) | Irinotecan HCl (20.0 mg/ml) |
| Cyclophosphamide (20.0 mg/ml) | Mechlorethamine HCl (1.0 mg/ml) |
| Cytarabine HCl (100 mg/ml) | Melphalan (5 mg/ml) |
| Dacarbazine (10 mg/ml) | Methotrexate (25 mg/ml) |
| Daunorubicin HCl (5.0 mg/ml) | Mitomycin-C (0.5 mg/ml) |
| Docetaxel (10.0 mg/ml) | Mitoxantrone (2.0 mg/ml) |
| Doxorubicin HCl (2.0 mg/ml) | Paclitaxel (6.0 mg/ml) |
| Epirubicin (Ellence) (2 mg/ml) | Rituximab (10 mg/ml) |
| Etoposide (20.0 mg/ml) | ThioTEPA (10.0 mg/ml) |
| Fludarabine (25 mg/ml) | Trisenox (0.1 mg/ml) |
| Fluorouracil (50.0 mg/ml) | Vincristine Sulfate (1.0 mg/ml) |

Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 30.7 minutes

Page 1 of 2

Eliz.th T. Channing-Williams

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

14113423 510(k) Number:

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

# ි | Kimberly-Clark Corporation

# Indications for Use (cont'd)

510(k) Number (if known): J≤ 1) 3423

Device Name(s): Kimberly-Clark PURPLE NITRILE-XTRA* Powder-Free Exam Glove

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

Elizabeth F. Clamie-Willens

(Division Sign-Jif) (Division Sign-Chr)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices . Avision Control, Dental Devices

i10(k) Number: K 113423

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

# ලිපි Kimberly-Clark Corporation

### Indications for Use

510(k) Number (if known):

Device Name(s):

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

#### 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 (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)

Erlabeth F. Clavine-Williams

Page 1 of 1_

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

510(k) Number: K113423

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

Image /page/12/Picture/1 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.

### Indications for Use

510(k) Number (if known): _ K // 3423

Device Name(s):

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

#### 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)

Elizabeth F. Clamin-Will

Page 1 of 1

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

K113423 510(k) Number: