KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM

K081089 · Kimberly-Clark Corp. · LZC · Jul 14, 2008 · General Hospital

Device Facts

• Record ID: K081089
• Device Name: KIMBERLY-CLARK STERLING NITRILE & NITRILE-XTRA POWDER-FREE EXAM GLOVES WITH CHEMOTHERAPY DRUG USE CLAIM
• Applicant: Kimberly-Clark Corp.
• Product Code: LZC · General Hospital
• Decision Date: Jul 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Kimberly-Clark* STERLING* Nitrile and Nitrile-Xtra* Powder-Free Exam Gloves are disposable devices intended for medical purposes that are worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Disposable, light gray, powder-free, textured-fingertip, ambidextrous nitrile examination gloves. Used by healthcare professionals to prevent cross-contamination between patient and examiner. Provides barrier protection against specific chemotherapy drugs. Tested for permeation resistance against various chemotherapy agents (e.g., Cyclophosphamide, Doxorubicin, Paclitaxel) per ASTM D 6978-05. Used in clinical settings; worn by physicians, nurses, or technicians. Output is a physical barrier; affects clinical decision-making by enabling safe handling of hazardous drugs and reducing infection risk.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (ISO 10993) included skin irritation, murine local lymph node assay, and systemic toxicity. Permeation testing performed per ASTM D 6978-05 and ASTM F 739-07 against 11 chemotherapy drugs; breakthrough times exceeded 240 minutes for most agents, with ThioTEPA showing breakthrough at 54.2 minutes.

Technological Characteristics

Material: Nitrile. Form: Powder-free, chlorinated, textured-fingertip, ambidextrous. Standards: ASTM D 6319-00a (dimensions, physical properties), ASTM D 5151-06 (pinholes), ASTM D 6124-06 (powder-free), ASTM D 6978-05 (chemotherapy permeation), ASTM F 739-07 (protective clothing). Biocompatibility: ISO 10993 Parts 10 and 11.

Indications for Use

Indicated for use as a patient examination glove, worn on the examiner's hand to prevent contamination between patient and examiner. Intended for medical purposes, including protection against chemotherapy drug exposure.

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* STERLING* Nitrile Powder-Free Exam Glove (K051347)
• Perusahaan Getah Asas Sdn. Bhd. Powdered Free Patient Examination Gloves, Blue Colored Non-Sterile (Low Dermatitus Potential and Chemotherapy Drug Protection Labeling Claims) (K042805)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The characters appear to be a mix of letters and numbers, possibly forming a code or a sequence. The writing style is cursive, with some characters connected to each other.

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

ें

Traditional 510(k) for Kimberly-Clark* STERLING* Nitrile & STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim

### Section 5. 510(k) SUMMARY

# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

| Submitter's Name: | Kimberly-Clark Corporation |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Address: | 1400 Holcomb Bridge Road<br>Roswell, GA 30076-2199 |
| Submitter's Phone No: | 770-587-8208 |
| Submitter's Fax No. | 920-969-5160 |
| Date of Preparation: | July 10, 2008 |
| Name of Device | |
| | Trade Name: |
| | Common Name: |
| Classification Name: | Glove, Patient Examination, Specialty - 80 LZC |
| Legally marketed device<br>to which equivalency is<br>claimed: | Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove - K051347 Perusahaan Getah Asas Sdn. Bhd. Powdered Free Patient Examination<br>Gloves, Blue Colored Non-Sterile (Low Dermatitus Potential and<br>Chemotherapy Drug Protection Labeling Claims) - K042805 |
| Description of the device: | Light gray nitrile, chlorinated, powder-free, textured fingertip, ambidextrous<br>patient examination glove that meets all of the requirements of ASTM<br>D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical<br>Application |
| Intended use of device: | The Kimberly-Clark* STERLING* Nitrile and Nitrile-Xtra* Powder-Free<br>Exam Gloves are disposable devices intended for medical purposes that are<br>worn on the examiner's hand to prevent contamination between patient and<br>examiner. |

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------:

#### Traditional 510(k) for Kimberly-Clark* STERLING* Nitrile & STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim

| Summary of technological<br>characteristics compared<br>to predicate device: | There are no different technological characteristics compared to the predicate<br>devices. They are all powder-free non-sterile nitrile exam gloves, one predicate<br>a gray color and the other a blue color. The Chemotherapy Drug Use Claim is<br>similar to that of Perusahaan Getah Asas Sdn. Bhd. Powdered Free Patient<br>Examination Gloves, Blue Colored Non-Sterile (Low Dermatitis Potential and<br>Chemotherapy Drug Protection Labeling Claims) - K042805 | | |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------------|
| Brief description of Non-<br>Clinical Tests: | Non-Clinical Tests | Standard | Performance |
| | Dimensions | ASTM D 6319-00a | Meets |
| | Physical Properties | ASTM D 6319-00a | Meets |
| | Freedom from pinholes | ASTM D 6319-00a<br>ASTM D 5151-06 | Meets |
| | Powder Free | ASTM D 6124-06<br>ASTM D 6319-00a | Meets |
| | ISO Skin Irritation Study | ISO 10993, Part 10 | Meets |
| | Murine Local Lymph Node Assay | ISO 10993, Part 10 | Meets |
| | ISO Systemic Toxicity Study | ISO 10993, Part 11 | Meets |
| | Resistance to Permeation<br>(Protective Clothing) | ASTM F 739-07 | See data below |
| | Resistance to Permeation<br>(Medical Gloves) | ASTM D 6978-05 | See data below |
| | Tested Chemotherapy Drug and<br>Concentration | Average Breakthrough Detection Time<br>(minutes) | |
| | Cyclophosphamide (20.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Doxorubicin HCI (2.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Etoposide (20.0 mg/ml) | No breakthrough up to 240 minutes | |
| | 5-Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Paclitaxel (Taxol) 6.0 mg/ml) | No breakthrough up to 240 minutes | |
| | ThioTEPA (10.0 mg/ml) | Avg. minutes before breakthrough = 54.2 | |
| | Cisplatin (1.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Dacarbazine (10.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Ifosfamide (50.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Mitoxantrone (2.0 mg/ml) | No breakthrough up to 240 minutes | |
| | Vincristine sulfate (1.0 mg/ml) | No breakthrough up to 240 minutes | |
| Brief description of Clinical<br>Tests: | No new clinical tests were required to support this 510(k) application. | | |
| Conclusions drawn from the<br>Non-Clinical and Clinical<br>Tests: | Non-clinical laboratory and animal based biocompatibility test data confirm<br>the Kimberly-Clark* STERLING* Nitrile and Nitrile-Xtra* Powder-Free<br>Exam Gloves Kimberly-Clark* STERLING* meets all applicable performance<br>and biocompatibility requirements. | | |

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

Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with stylized wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### JUL 1 4 2008

Mr. Richard V. Wolfe Associate Director, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076

Re: K081089

Trade/Device Name: Kimberly-Clark* STERLING* Nitrile and STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: June 27, 2008 Received: July 2, 2008

Dear Mr. Wolfe:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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

#### Page 2 -Mr. Wolfe

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-{See Below For Phone Numbers]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

. Sincerely yours,

Anthony D. Watson for

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Kimberly-Clark Corporation

#### INDICATIONS FOR USE

- Applicant: Kimberly-Clark Corporation 510(k) Number: K081089 Kimberly-Clark* STERLING* Nitrile and STERLING* Nitrile-Device Name: Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim Indications for Based upon 21CFR§880.6250 "Patient examination glove" Use: A patient examination glove is a medical device intended for
medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

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

## Concurrence of CDRH Office of Device Evaluation (ODE)

Prescription Use Per 21CFR 801.109 Subpart D Over-The-Counter Per 21CFR 801.109 Subpart C

×

Tula N. Murphy, L.S.

OR

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

510(k) Number: K811899