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K Number
K131841
Device Name
KIMBERLY-CLARK LAVENDER NITRILE POWDER-FREE EXAM GLOVE
Manufacturer
KIMBERLY-CLARK CORP.
Date Cleared
2013-11-07

(139 days)

Product Code
LZA
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
Nitrile, powder-free, textured-fingertip, ambidextrous patient examination glove with a polymer coating on the donning surface without chlorination.
More Information

K081260, K992830

Not Found

No
The device description and performance studies focus on the physical properties and performance of examination gloves, with no mention of AI or ML.

No
The device is described as an exam glove, intended to prevent contamination, not to treat a medical condition.

No
Explanation: The device is an exam glove, intended to prevent contamination between patient and examiner. It does not diagnose any condition.

No

The device description clearly states it is a physical glove made of nitrile, indicating it is a hardware device, not software.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample from the human body.
  • Device Description: The description details the material and features of a glove, not a reagent, instrument, or system used for in vitro testing.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in samples
    • Providing information for diagnosis, monitoring, or screening

The device is a medical device, specifically an examination glove, but it falls under a different regulatory category than IVDs.

N/A

Intended Use / Indications for 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.

Product codes

LZA

Device Description

Nitrile, powder-free, textured-fingertip, ambidextrous patient examination glove with a polymer coating on the donning surface without chlorination.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

examiner's hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical laboratory and animal based biocompatibility test data confirm the KIMBERLY-CLARK* LAVENDER* Nitrile Powder-Free Exam Gloves meet all 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K081260, K992830

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.6250 Non-powdered patient examination glove.

(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

0

K131841

3.510K Summary
ApplicantKimberly-Clark
1400 Holcomb Bridge Road
Roswell, GA 30076
Date of PreparationNovember 1, 2013
Official
CorrespondentChris Macauley
Technical Leader, Regulatory Affairs
Tel: 770.587.8638
Fax: 920.255.4648
email: cmacaul@kcc.comNOV 07 2013
Trade Name:KIMBERLY-CLARK* LAVENDER* NITRILE Powder-
Free Exam Gloves
Classification Name:Patient examination glove.
Device Classification
and Product CodeClass I per 21 CFR §880.6250
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.

1

SUBSTANTIAL EQUIVALENCY
ElementPredicate
(K081260)Predicate (K992830)Subject Device
KIMBERLY-CLARK*
LAVENDER*
NITRILE Powder-
Free Exam GlovesSafeskin Polymer-
Coated Nitrile
Examination GlovesKIMBERLY-CLARK*
LAVENDER* NITRILE
Powder-Free Exam Gloves
INDICATIONS FOR USEExam Gloves are
disposable Devices,
intended for medical
purposes that are
worn on the
examiner's hand to
prevent
contamination
between patient and
examiner.SameSame
FDA DEVICE
CLASSIFICATIONLZA, Class I Patient
Examination GloveSameSame
Trade NameKIMBERLY-CLARK*
LAVENDER*
NITRILE Powder-
Free Exam GlovesSafeskin Polymer-
Coated Nitrile
Examination GlovesKIMBERLY-CLARK*
LAVENDER* NITRILE
Powder-Free Exam Gloves
ConstructionNitrile, chlorinated,
powder-free,
textured-fingertip,
ambidextrous
patient examination
glove.Dipped in nitrile latex
compound using a
former release agent
and coated with a
polymer on the
donning (outer)
surface. No donning
powder is used.Nitrile, powder-free, textured-
fingertip, ambidextrous patient
examination glove with a
polymer coating on the
donning surface without
chlorination.
Applicable
Performance
RequirementsASTM D5151-99ASTM D5151-92ASTM D5151-06
ASTM D6319-00aATSM6319-99ASTM D6319-10
ASTM D6124-06ASTM6124-06ASTM D6124-06
ISO 10993-10
ISO 10993-11ISO 10993-10ISO 10993-10
ISO 10993-11
Supplied non-SterileYesYesYes

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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
technological
characteristics
compared to
predicate device:There are no different technological characteristics of the Subject Device compared to
the predicate devices. They are both powder-free non-sterile nitrile exam gloves with one
predicate being chlorinated and the other predicate being non-chlorinated and having a
polymer-coating on the donning side.
Non-Clinical TestsDimensionsASTM D 6319-10Meets
Physical PropertiesASTM D 6319-10Meets
Freedom from pinholesASTM D 6319-10Meets
ASTM D 5151-06Meets
Powder FreeASTM D 6124-06Meets
ASTM D 6319-10Meets
ISO Skin Irritation StudyISO 10993, Part 10Meets
Murine Local Lymph Node AssayISO 10993, Part 10Meets
ISO Systemic Toxicity StudyISO 10993, Part 1Meets
Clinical Tests:No new clinical tests were required to support this 510(k) notification.
ConclusionsNon-clinical laboratory and animal based biocompatibility test data confirm
the KIMBERLY-CLARK* LAVENDER* Nitrile Powder-Free Exam Gloves meet all
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.

4

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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.

・4:41 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : FOR FDA USE ONLY . . . " " " ੈ ਜਾਣਾ .. ... ...

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)