KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)

K081027 · Kimberly-Clark Corp. · LZA · Jun 30, 2008 · General Hospital

Device Facts

• Record ID: K081027
• Device Name: KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)
• Applicant: Kimberly-Clark Corp.
• Product Code: LZA · General Hospital
• Decision Date: Jun 30, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

The Kimberly-Clark* STERLING Nitrile Powder-Free Exam Glove, Sterile, is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Story

Sterile, light gray, powder-free, textured fingertip, ambidextrous nitrile patient examination glove. Used by healthcare examiners to prevent cross-contamination between patient and examiner. Device is disposable and provided in sterile packaging. No electronic or mechanical components.

Clinical Evidence

No clinical data. Biocompatibility and performance supported by non-clinical bench testing including dimensions, physical properties, freedom from pinholes, powder-free status, sterility, and ISO 10993 biocompatibility studies (skin irritation, systemic toxicity, and murine local lymph node assay).

Technological Characteristics

Material: Nitrile. Features: Chlorinated, powder-free, textured fingertip, light gray color. Sterilization: Gamma irradiation. Standards: ASTM D 6319-00a (dimensions, physical properties), ASTM D 5151-06 (pinholes), ASTM D 6124-06 (powder-free), ISO 11137-2 (sterility), ISO 10993-10/11 (biocompatibility).

Indications for Use

Indicated for use as a patient examination glove worn on the examiner's hand to prevent contamination between patient and examiner.

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)
• Kimberly-Clark* PURPLE NITRILE* Powder-Free Exam Glove, Sterile (K992062)

Submission Summary (Full Text)

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K081027

# දිවූ Kimberly-Clark Corporation

## Abbreviated 510(k) for Kimberly-Clark* Sterile STERLING* Nitrile Powder-Free Exam Glove

# Section 5. 510(k) SUMMARY

JUN 3 0 2008

# 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: | April 9, 2008 |
| Trade Name: | Kimberly-Clark* Sterile STERLING* Nitrile Powder-Free Exam Glove |
| Common Name: | Patient examination glove |
| Classification Name: | Glove, Patient Examination, Poly - 80 LZA |
| Legally marketed device<br>to which equivalency is<br>claimed: | • Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove (K051347)<br>• Kimberly-Clark* PURPLE NITRILE* Powder-Free Exam Glove, Sterile<br>(K992062) |
| Description of the device: | Light gray nitrile, chlorinated, powder-free, sterile, textured fingertip,<br>ambidextrous patient examination glove |
| Intended use of device: | The Kimberly-Clark* STERLING Nitrile Powder-Free Exam Glove, Sterile,<br>is a disposable device intended for medical purposes that is worn on the<br>examiner's hand to prevent contamination between patient and examiner. |
| 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 chlorinated, powder-free nitrile gloves. This specific<br>glove is gray in color, packaged in pairs in packaging to maintain sterility and<br>sterilized by gamma irradiation. |

# Page 1 of 2 - Section 5 510(k) Summary

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K081027

Image /page/1/Picture/1 description: The image shows the Kimberly-Clark Corporation logo. 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 aligned horizontally to the right of the symbol.

#### Abbreviated 510(k) for Kimberly-Clark* Sterile STERLING* Nitrile Powder-Free Exam Glove ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Brief description of Non-Clinical Tests: | Non-Clinical Tests<br>Dimensions<br>Physical Properties<br>Freedom from pinholes<br>Powder Free<br>Sterility<br>ISO Skin Irritation Study<br>Murine Local Lymph Node Assay<br>ISO Systemic Toxicity Study | Standard<br>ASTM D 6319-00a<br>ASTM D 6319-00a<br>ASTM D 6319-00a<br>ASTM D 5151-06<br>ASTM D 6124-06<br>ASTM D 6319-00a<br>ISO 11137-2<br>ISO 10993, Part 10<br>ISO 10993, Part 10<br>ISO 10993, Part 11 |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Brief description of Clinical Tests: | No new clinical tests were required to support this 510(k) application. | |
| Conclusions drawn from the Non-Clinical and Clinical Tests: | Non-clinical laboratory and animal based biocompatibility test data confirm the Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove, Sterile, meets all applicable performance and biocompatibility requirements. | |
| Other Information deemed necessary by the FDA: | None | |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 3 0 2008

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

Re: K081027

Trade/Device Name: KIMBERLY-CLARK* Sterile STERLING* Nitrile Powder-Free Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 18, 2008 Received: June 20, 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.

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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 (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 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/dsma/dsmamain.html

Sincerely yours,

signature

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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K081027

# 3 Kimberly-Clark Corporation

## INDICATIONS FOR USE

Kimberly-Clark Corporation Applicant:

510(k) Number:

Device Name:

KIMBERLY-CLARK* Sterile STERLING* Nitrile Powder-Free Exam Glove

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<br>Per 21CFR 801.109 Subpart D | OR | Over-The-Counter<br>Per 21CFR 801.109 Subpart C <span style="text-decoration: underline;">X</span> |
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(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

| 510(k) Number: | K081027 |
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