(139 days)
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.
Nitrile, powder-free, textured-fingertip, ambidextrous patient examination glove with a polymer coating on the donning surface without chlorination.
The document describes the Kimberly-Clark LAVENDER NITRILE Powder-Free Exam Gloves, which is a Class I medical device. The submission is a 510(k) premarket notification, indicating that the device is seeking to demonstrate substantial equivalence to existing legally marketed predicate devices rather than proving novel safety and efficacy.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria & Test | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Meets |
| Physical Properties | ASTM D 6319-10 | Meets |
| Freedom from Pinhole | ASTM D 6319-10 | Meets |
| Freedom from Pinhole | ASTM D 5151-06 | Meets |
| Powder Free | ASTM D 6124-06 | Meets |
| Powder Free | 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 | (Not Applicable) | No new clinical tests required |
| Overall Conclusion (Functional & Biocompatibility) | FDA recognized consensus standards, acceptable pinhole quality level (AQL) | Meets all applicable exam glove performance and biocompatibility requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes non-clinical tests (bench testing and animal-based biocompatibility studies) for the Kimberly-Clark LAVENDER* NITRILE Powder-Free Exam Gloves. It does not provide specific sample sizes for these tests, nor does it detail the provenance of the data in terms of geographical origin or retrospective/prospective nature. However, for bench testing of medical gloves, these tests typically involve a defined number of gloves per batch or lot to ensure statistical significance, and ISO 10993 standards for biocompatibility also outline testing parameters.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Since this involves laboratory and animal-based testing for a Class I general purpose exam glove, the concept of "experts" establishing ground truth in the way it's used for AI/diagnostic devices (e.g., radiologists, pathologists) is not directly applicable. The "ground truth" for these tests is established by adhering to the methodologies and pass/fail criteria defined in the referenced ASTM and ISO standards, which are developed by expert committees in their respective fields (e.g., materials science, toxicology). The individuals conducting these tests would be trained laboratory personnel.
4. Adjudication Method for the Test Set:
Not applicable in the context of bench and animal-based biocompatibility testing for an exam glove. The results are typically quantitative measurements or observations against predefined pass/fail criteria within the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is specifically relevant for diagnostic devices that involve human interpretation of medical images or data, often comparing AI-assisted performance to unassisted human performance. This is not applicable to an exam glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No. This concept is for AI/software devices. The Kimberly-Clark LAVENDER* NITRILE Powder-Free Exam Gloves are a physical medical device. The "performance" described here relates to the physical and chemical properties of the glove itself.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is based on the objective measurements and observations derived from standardized test methods (ASTM D6319, ASTM D5151, ASTM D6124) for physical properties and freedom from pinholes, and results from animal-based biocompatibility studies (ISO 10993 Parts 1, 10) for skin irritation, sensitization, and systemic toxicity. These standards define the expected performance and safety profile for medical examination gloves.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
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K131841
| 3. | 510K Summary | |
|---|---|---|
| Applicant | Kimberly-Clark1400 Holcomb Bridge RoadRoswell, GA 30076 | |
| Date of Preparation | November 1, 2013 | |
| OfficialCorrespondent | Chris MacauleyTechnical Leader, Regulatory AffairsTel: 770.587.8638Fax: 920.255.4648email: cmacaul@kcc.com | NOV 07 2013 |
| Trade Name: | KIMBERLY-CLARK* LAVENDER* NITRILE Powder-Free Exam Gloves | |
| Classification Name: | Patient examination glove. | |
| Device Classificationand Product Code | Class I per 21 CFR §880.6250Product 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(K081260) | Predicate (K992830) | Subject Device |
| KIMBERLY-CLARK*LAVENDER*NITRILE Powder-Free Exam Gloves | Safeskin Polymer-Coated NitrileExamination Gloves | KIMBERLY-CLARK*LAVENDER* NITRILEPowder-Free Exam Gloves | |
| INDICATIONS FOR USE | Exam Gloves aredisposable Devices,intended for medicalpurposes that areworn on theexaminer's hand topreventcontaminationbetween patient andexaminer. | Same | Same |
| FDA DEVICECLASSIFICATION | LZA, Class I PatientExamination Glove | Same | Same |
| Trade Name | KIMBERLY-CLARK*LAVENDER*NITRILE Powder-Free Exam Gloves | Safeskin Polymer-Coated NitrileExamination Gloves | KIMBERLY-CLARK*LAVENDER* NITRILEPowder-Free Exam Gloves |
| Construction | Nitrile, chlorinated,powder-free,textured-fingertip,ambidextrouspatient examinationglove. | Dipped in nitrile latexcompound using aformer release agentand coated with apolymer on thedonning (outer)surface. No donningpowder is used. | Nitrile, powder-free, textured-fingertip, ambidextrous patientexamination glove with apolymer coating on thedonning surface withoutchlorination. |
| ApplicablePerformanceRequirements | 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 10993-10ISO 10993-11 | ISO 10993-10 | ISO 10993-10ISO 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 oftechnologicalcharacteristicscompared topredicate device: | There are no different technological characteristics of the Subject Device compared tothe predicate devices. They are both powder-free non-sterile nitrile exam gloves with onepredicate being chlorinated and the other predicate being non-chlorinated and having apolymer-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 confirmthe KIMBERLY-CLARK* LAVENDER* Nitrile Powder-Free Exam Gloves meet allapplicable 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 (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.
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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)
§ 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.