(68 days)
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.
Lavender colored nitrile, chlorinated, powder-free, textured fingertip, ambidextrous patient examination glove that meets all of the requirements of ASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
This document describes the acceptance criteria and study proving the Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves meet them.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Dimensions (ASTM D 6319-00a) | Meets |
| Physical Properties (ASTM D 6319-00a) | Meets |
| Freedom from pinholes (ASTM D 6319-00a & ASTM D 5151-06) | Meets |
| Powder Free (ASTM D 6124-06 & ASTM D 6319-00a) | 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 11) | Meets |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each "test set" within the non-clinical studies. The studies are described as "Non-Clinical Tests" and "Animal Based Biocompatibility Test Data," which implies testing was performed on either physical gloves (for dimensions, physical properties, pinholes, powder-free) or on animals (for biocompatibility). The provenance of the data is not specified in terms of country of origin but is implied to be from laboratory testing. These are retrospective tests performed to demonstrate compliance with established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a physical product (exam glove) and the acceptance criteria are based on standardized performance and biocompatibility tests, not on expert interpretation of data like medical imaging. Therefore, no "experts" in the sense of clinical reviewers are used to establish ground truth for the performance parameters.
4. Adjudication Method for the Test Set
Not applicable. The performance is measured against objective standards (e.g., ASTM and ISO standards) and not through subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device that would involve human readers interpreting cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Not applicable. This is a physical medical device (exam glove), not an algorithm or AI system. The performance is inherent to the glove's physical and biological properties.
7. Type of Ground Truth Used
The ground truth used for performance criteria is established by recognized international and national standards:
- Performance and Physical Characteristics: ASTM D 6319-00a (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D 5151-06 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D 6124-06 (Standard Test Method for Residual Powder on Medical Gloves). These standards define objective, measurable parameters.
- Biocompatibility: ISO 10993, Part 10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization) and ISO 10993, Part 11 (Biological evaluation of medical devices - Tests for systemic toxicity). These standards provide protocols for animal-based studies to assess biological safety.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device; therefore, there is no "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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්රිග් Kimberly-Clark Corporation
Traditional 510(k) for Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves
Section 5. 510(k) SUMMARY
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SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
| Submitter's Name: | Kimberly-Clark Corporation |
|---|---|
| Submitter's Address: | 1400 Holcomb Bridge RoadRoswell, GA 30076-2199 |
| Submitter's Phone No: | 770-587-8208 |
| Submitter's Fax No. | 920-969-5160 |
| Date of Preparation: | May 1, 2008 |
| Name of Device | |
| Trade Name: | Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Glove |
| Common Name: | Patient examination glove |
| Classification Name: | Glove, Patient Examination, Poly - 80 LZA |
| Legally marketed deviceto which equivalency isclaimed: | Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove - K051347 |
| Description of the device: | Lavender colored nitrile, chlorinated, powder-free, textured fingertip,ambidextrous patient examination glove that meets all of the requirements ofASTM D 6319-00a, Standard Specification for Nitrile Examination Gloves forMedical Application. |
| Intended use of device: | The Kimberly-Clark* Lavender* Powder-Free Exam Gloves are disposableDevices, intended for medical purposes that are worn on the examiner's handto prevent contamination between patient and examiner. |
| Summary of technologicalcharacteristics comparedto predicate device: | There are no different technological characteristics compared to the predicatedevice. They are both powder-free non-sterile nitrile exam gloves, the predicatebeing a light gray color and the subject of this application being a lavender color. |
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Traditional 510(k) for Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
(Continued)
| Brief description of Non-Clinical Tests: | Non-Clinical Tests | Standard | Performance |
|---|---|---|---|
| Dimensions | ASTM D 6319-00a | Meets | |
| Physical Properties | ASTM D 6319-00a | Meets | |
| Freedom from pinholes | ASTM D 6319-00a | Meets | |
| ASTM D 5151-06 | Meets | ||
| Powder Free | ASTM D 6124-06 | Meets | |
| ASTM D 6319-00a | 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 11 | Meets | |
| Brief description of ClinicalTests: | No new clinical tests were required to support this 510(k) application. | ||
| Conclusions drawn from theNon-Clinical and ClinicalTests: | 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. | ||
| Other Information deemednecessary by the FDA: | None |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard V. Wolfe Associate Director, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K081260
Trade/Device Name: Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 16, 2008 Received: June 18, 2008
JUL - 9 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 (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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clues
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
INDICATIONS FOR USE
Kimberly-Clark Corporation Applicant:
K081260 510(k) Number:
Device Name: Kimberly-Clark* Lavender* Nitrile Powder-Free Exam Gloves
Based upon 21 CFR§880.6250 "Patient examination glove" Indications for 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.
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Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21CFR 801.109 Subpart D OR
Over-The-Counter X Per 21CFR 801.109 Subpart C
Clus ts
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081260
§ 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.