KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE

K131841 · Kimberly-Clark Corp. · LZA · Nov 7, 2013 · General Hospital

Device Facts

• Record ID: K131841
• Device Name: KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
• Applicant: Kimberly-Clark Corp.
• Product Code: LZA · General Hospital
• Decision Date: Nov 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

KIMBERLY-CLARK* LAVENDER* NITRILE 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 nitrile patient examination glove; textured-fingertip; ambidextrous; polymer-coated donning surface. Used in clinical settings by healthcare providers to provide a protective barrier against contamination between patient and examiner. Device is non-sterile. Benefits include protection against cross-contamination during medical examinations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM D6319-10 (dimensions, physical properties, pinholes), ASTM D5151-06 (freedom from pinholes), ASTM D6124-06 (powder-free), and ISO 10993-10/11 (biocompatibility/toxicity).

Technological Characteristics

Nitrile material; powder-free; textured-fingertip; ambidextrous; polymer-coated donning surface. Non-sterile. Complies with ASTM D6319-10, ASTM D5151-06, ASTM D6124-06, ISO 10993-10, and ISO 10993-11.

Indications for Use

Indicated for use as a disposable patient examination glove worn by examiners to prevent cross-contamination between patient and examiner. Suitable for both prescription and over-the-counter use.

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* LAVENDER* NITRILE Powder-Free Exam Gloves (K081260)
• Safeskin Polymer-Coated Nitrile Examination Gloves (K992830)

Submission Summary (Full Text)

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# K131841

| 3. | | 510K Summary |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------|
| Applicant | Kimberly-Clark<br>1400 Holcomb Bridge Road<br>Roswell, GA 30076 | |
| Date of Preparation | November 1, 2013 | |
| Official<br>Correspondent | Chris Macauley<br>Technical Leader, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>email: [e-mail] | NOV 07 2013 |
| Trade Name: | KIMBERLY-CLARK* LAVENDER* NITRILE Powder-<br>Free Exam Gloves | |
| Classification Name: | Patient examination glove. | |
| Device Classification<br>and Product Code | Class I per 21 CFR §880.6250<br>Product Code - LZA | |

## PREDICATE DEVICES:

K081260 - KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves

K992830 - Safeskin Polymer-Coated Nitrile Examination Gloves

# SUBSTANTIAL EQUIVALENCE:

The subject KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves are substantially equivalent to the KIMBERL Y-CLARK * LAVENDER* NITRILE Powder-Free Exam Gloves cleared under K081260 and the Safeskin Polymer-Coated Nitrile Examination Gloves cleared under K992830. The subject KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves and the predicate devices have the same intended use and same fundamental scientific technology. Bench testing has demonstrated that the subject KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Glove performs the same function as the predicate devices and that any minor differences between the subject device and the predicate devices has no adverse impact to safety or efficacy.

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| SUBSTANTIAL EQUIVALENCY | | | |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Element | Predicate<br>(K081260) | Predicate (K992830) | Subject Device |
| | KIMBERLY-CLARK*<br>LAVENDER*<br>NITRILE Powder-<br>Free Exam Gloves | Safeskin Polymer-<br>Coated Nitrile<br>Examination Gloves | KIMBERLY-CLARK*<br>LAVENDER* NITRILE<br>Powder-Free Exam Gloves |
| INDICATIONS FOR USE | Exam Gloves are<br>disposable Devices,<br>intended for medical<br>purposes that are<br>worn on the<br>examiner's hand to<br>prevent<br>contamination<br>between patient and<br>examiner. | Same | Same |
| FDA DEVICE<br>CLASSIFICATION | LZA, Class I Patient<br>Examination Glove | Same | Same |
| Trade Name | KIMBERLY-CLARK*<br>LAVENDER*<br>NITRILE Powder-<br>Free Exam Gloves | Safeskin Polymer-<br>Coated Nitrile<br>Examination Gloves | KIMBERLY-CLARK*<br>LAVENDER* NITRILE<br>Powder-Free Exam Gloves |
| Construction | Nitrile, chlorinated,<br>powder-free,<br>textured-fingertip,<br>ambidextrous<br>patient examination<br>glove. | Dipped in nitrile latex<br>compound using a<br>former release agent<br>and coated with a<br>polymer on the<br>donning (outer)<br>surface. No donning<br>powder is used. | Nitrile, powder-free, textured-<br>fingertip, ambidextrous patient<br>examination glove with a<br>polymer coating on the<br>donning surface without<br>chlorination. |
| Applicable<br>Performance<br>Requirements | ASTM D5151-99 | ASTM D5151-92 | ASTM D5151-06 |
| | ASTM D6319-00a | ATSM6319-99 | ASTM D6319-10 |
| | ASTM D6124-06 | ASTM6124-06 | ASTM D6124-06 |
| | ISO 10993-10<br>ISO 10993-11 | ISO 10993-10 | ISO 10993-10<br>ISO 10993-11 |
| Supplied non-Sterile | Yes | Yes | Yes |

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# INTENDED USE:

KIMBERLY-CLARK* LAVENDER* NITRILE 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.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:

| TECHNOLOGICAL CHARACTERISTICS | | | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|-------|
| Summary of<br>technological<br>characteristics<br>compared to<br>predicate device: | There are no different technological characteristics of the Subject Device compared to<br>the predicate devices. They are both powder-free non-sterile nitrile exam gloves with one<br>predicate being chlorinated and the other predicate being non-chlorinated and having a<br>polymer-coating on the donning side. | | |
| Non-Clinical Tests | Dimensions | ASTM D 6319-10 | Meets |
| | Physical Properties | ASTM D 6319-10 | Meets |
| | Freedom from pinholes | ASTM D 6319-10 | Meets |
| | | ASTM D 5151-06 | Meets |
| | Powder Free | ASTM D 6124-06 | Meets |
| | | ASTM D 6319-10 | 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 1 | Meets |
| Clinical Tests: | No new clinical tests were required to support this 510(k) notification. | | |
| Conclusions | Non-clinical laboratory and animal based biocompatibility test data confirm<br>the KIMBERLY-CLARK* LAVENDER* Nitrile Powder-Free Exam Gloves meet all<br>applicable exam glove performance and biocompatibility requirements. | | |

Functional test results meet acceptance criteria and demonstrate that the subject device is safe and effective for use in humans and performs as well as the legally marketed predicate devices. The Subject Device meets the FDA recognized consensus standards, or equivalent methods, and acceptable pinhole quality level (AQL) as shown by the data.

### CONCLUSION:

Performance testing has demonstrated that the subject KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Glove is substantially equivalent to the predicate K081260, KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves, and to predicate K992830, Safeskin Polymer-Coated Nitrile Examination Gloves.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

November 7, 2013

Kimberly-Clark Corporation Ms. Christine Macauley Technical Leader, Regulatory Affairs 1400 Holcomb Bridge Road ROSWELL, GA 30076

Re: K131841

Trade/Device Name: Lavender Nitrile Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: August 15, 2013 Received: August 19, 2013-

Dear Ms. Macauley:

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 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 - Ms. Macauley

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

huo. Ida.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Pari 803), please go to

http://www.fda.gov/MedicalDevices/Safetv/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Image /page/4/Picture/7 description: The image shows a combination of a signature and some text. The text includes "Tejashri Purohit-Sheth, M.D.", "Clinical Deputy Director", and "DAGRID". The word "FOR" is also present in the image, but it is separated from the other text.

Sincerely yours,

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page

#### 510(k) Number (if known) KI31841

#### Device Name

KIMBERLY-CLARK LAVENDER NITRILE Powder-Free Exam Gloves

#### Indications for Use (Describe)

KIMBERLY-CLARK LAVENDER NITRILE 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.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

[x] Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Terrel Cunningham

Digitally signed by Terrell A. Cunningham · S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300095968. cn=Terrell A: Cunningham -S Date: 2013.10.31 09:41:44 -04'00

FORM FDA 3881 (9/13)