KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE

K051347 · Kimberly-Clark Corp. · LZA · Jun 7, 2005 · General Hospital

Device Facts

• Record ID: K051347
• Device Name: KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
• Applicant: Kimberly-Clark Corp.
• Product Code: LZA · General Hospital
• Decision Date: Jun 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended 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.

Device Story

Disposable nitrile powder-free examination glove; worn by healthcare personnel to provide barrier protection; prevents cross-contamination between patient and examiner; used in clinical settings; device functions as a physical barrier; no electronic or mechanical components.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-10, ISO 10993-11) and physical performance testing per ASTM D 6319, D 5151, and D 6124.

Technological Characteristics

Nitrile material; powder-free; meets ASTM D 6319 (dimensions, physical properties, pinholes), ASTM D 5151 (pinholes), and ASTM D 6124 (powder-free). Biocompatibility tested per ISO 10993-10 (irritation/sensitization) and ISO 10993-11 (systemic toxicity).

Indications for Use

Indicated for use by healthcare and similar personnel as a protective barrier to prevent contamination between the examiner and the patient.

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 NITRILE* Powder-Free Exam Glove (80LZA)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2005

Mr. Richard V. Wolfe Manager, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076-2199

Re: K051347

Trade/Device Name: Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 23, 2005 Received: May 24, 2005

Dear Mr. Wolfe:

This letter corrects our substantially equivalent letter of June 7, 2005, for the device name.

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.

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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 (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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours.

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

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Kimberly-Clark Corporation

HEALTH CARE SECTOR 1400 Holcomb Bridge Road Roswell, GA 30076-2199

Phone: [phone] Fax: [phone]

## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

- [[] 510(k) Summary of Safety and Effectiveness Information
- [2] Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076-2199 Telephone: [phone] Fax: [phone] Contact: Richard V. Wolfe Telephone: [phone] Fax: [phone] [3] Trade Name: KIMBERLY-CLARK* STERLING* Nitrile Powder-Free Exam Glove Common Name: Patient Examination Gloves, Nitrile Classification Name: Patient Examination Gloves, Nitrile [4] The predicate device is a Class I, SAFESKIN* PURPLE NITRILE* Powder-Free Exam
- Glove, 80LZA, that meets all of the requirements of ASTM D 6319, "Standard Specification for Nitrile Examination Gloves for Medical Application".
- [૨] The powder-free nitrile exam glove meets the current specifications of ASTM D 6319, "Standard Specification for Nitrile Examination Gloves for Medical Application".
- [6] The powder-free nitrile exam gloves are disposable devices intended to be worn by healthcare and similar personnel to prevent contamination between such personnel and the patient.
- The powder-free nitrile exam gloves possess the following technological characteristics [7] (as compared to ASTM or equivalent standards):

| Characteristics | Standards |
|-----------------------|-------------------|
| Dimensions | Meets ASTM D 6319 |
| Physical Properties | Meets ASTM D 6319 |
| Freedom from pinholes | Meets ASTM D 6319 |
| | Meets ASTM D 5151 |
| Powder Free | Meets ASTM D 6124 |
| | Meets ASTM D 6319 |

Attachment H (page 1 of 2)

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Kimberly-Clark Corporation

HEALTH CARE SECTOR 1400 Holcomb Bridge Road Roswell, GA 30076-2199

Phone: [phone] Fax: [phone]

## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION (Cont'd)

Biocompatibility - Biocompatibility testing was conducted to the following parts of ISO 10993, "Biological Evaluation of Medical Devices":

- Part 10, "Tests for Irritation and Sensitization" .
- . Part 11, "Tests for Systemic Toxicity(ISO):

| Study Title | Test Animal | Results |
|---------------------------------------------|-------------|---------|
| ISO Skin Irritation Study | Rabbit | Passed |
| Murine Local Lymph Node Assay (LLNA) | Mouse | Passed |
| USP and ISO Systemic Toxicity Study Extract | Mouse | Passed |

- The performance test data that support a determination of substantial equivalence are [8] described above.
- [9] Clinical data are not needed for examination gloves.
- It can be concluded that the powder-free nitrile exam glove is safe and effective and will [10] perform according to the glove performance standards referenced in Section 7 above, thereby meeting ASTM standards, FDA requirements, and the labeling claims for the product. Consequently, this exam glove is substantially equivalent to currently marketed exam gloves.

Attachment H (page 2 of 2)

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Image /page/4/Picture/0 description: The image shows the logo of Kimberly-Clark Corporation. The logo consists of a circular symbol with a cross inside, followed by the company name in bold, black letters. Below the company name, the words "HEALTH CARE SECTOR" are printed in smaller letters.

HEALTH CARE SECTOR 1400 Holcomb Bridge Road Roswell, GA 30076-2199

Phone: [phone] Fax: [phone]

## INDICATIONS FOR USE

Kimberly-Clark Corporation Applicant:

510(k) Number:

KIMBERLY-CLARK* STERLING* Nitrile Powder-Free Latex Exam Device Name: Glove

Indications for Use: Based upon 21CFR§880.6250 "Patient examination glove":

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)

Shule H. Murphy 6/4/2

Division of Anesthesiology, General Ho 510(k) Number

| Prescription Use | |
|-------------------|--|
| Per 21CFR 801.109 | |

Over-The-Counter

Attachment C

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