(81 days)
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.
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.
Light gray nitrile, chlorinated, powder-free, sterile, textured fingertip, ambidextrous patient examination glove
The Kimberly-Clark* Sterile STERLING* Nitrile Powder-Free Exam Glove (K081027) is a patient examination glove. The following information details its acceptance criteria and the study that proves the device meets these criteria:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are based on compliance with several ASTM and ISO standards for properties typical of patient examination gloves. The device's performance is reported as meeting these requirements based on non-clinical tests.
| Acceptance Criteria | Standard | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a | Meets the standard |
| Physical Properties | ASTM D 6319-00a | Meets the standard |
| Freedom from pinholes | ASTM D 6319-00a | Meets the standard AQL (Acceptable Quality Level) of 2.5 for freedom from pinholes, as defined in ASTM D 5151-06. |
| Powder Free | ASTM D 5151-06 | Meets the standard. The device is distinctly labeled as "Powder-Free." |
| Sterility | ASTM D 6124-06; ISO 11137-2 | Meets the sterility requirements. The device is specified as "sterile" and sterilized by gamma irradiation. |
| ISO Skin Irritation Study | ISO 10993, Part 10 | Meets the standard. No significant skin irritation observed. |
| Murine Local Lymph Node Assay | ISO 10993, Part 10 | Meets the standard. No sensitization potential observed. |
| ISO Systemic Toxicity Study | ISO 10993, Part 11 | Meets the standard. No systemic toxicity observed. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test. The data provenance is derived from internal non-clinical laboratory and animal-based biocompatibility tests conducted by Kimberly-Clark Corporation to confirm compliance with established standards. The data is retrospective in the sense that it pertains to the product being submitted for 510(k) clearance, reflecting the outcome of these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is established through compliance with recognized industry standards (ASTM and ISO) for physical properties, sterility, and biocompatibility. These standards define the objective measures for performance, rather than requiring expert consensus for a "ground truth" in the diagnostic sense.
4. Adjudication method for the test set
Not applicable. As the evaluation relies on objective measurements against established standards, an adjudication method in the context of expert review is not required. The results of the non-clinical tests are directly compared to the specified limits of the standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a sterile patient examination glove and does not involve AI assistance or human-reader interpretations.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device and does not involve an algorithm.
7. The type of ground truth used
The ground truth is established through objective measurements compared against published national and international standards (ASTM, ISO) for physical properties, sterility, and biocompatibility. For example, for "Freedom from pinholes," the ground truth is defined by the AQL (Acceptable Quality Level) of 2.5 specified in ASTM D 5151-06.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
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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 RoadRoswell, 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 deviceto which equivalency isclaimed: | • Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove (K051347)• Kimberly-Clark* PURPLE NITRILE* Powder-Free Exam Glove, Sterile(K992062) |
| Description of the device: | Light gray nitrile, chlorinated, powder-free, sterile, textured fingertip,ambidextrous patient examination glove |
| Intended use of device: | The Kimberly-Clark* STERLING Nitrile Powder-Free Exam Glove, Sterile,is a disposable device intended for medical purposes that is worn on theexaminer's hand to prevent contamination between patient and examiner. |
| Summary of technologicalcharacteristics comparedto predicate device: | There are no different technological characteristics compared to the predicatedevices. They are all chlorinated, powder-free nitrile gloves. This specificglove is gray in color, packaged in pairs in packaging to maintain sterility andsterilized by gamma irradiation. |
Page 1 of 2 - Section 5 510(k) Summary
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Abbreviated 510(k) for Kimberly-Clark* Sterile STERLING* Nitrile Powder-Free Exam Glove ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Brief description of Non-Clinical Tests: | Non-Clinical TestsDimensionsPhysical PropertiesFreedom from pinholesPowder FreeSterilityISO Skin Irritation StudyMurine Local Lymph Node AssayISO Systemic Toxicity Study | StandardASTM D 6319-00aASTM D 6319-00aASTM D 6319-00aASTM D 5151-06ASTM D 6124-06ASTM D 6319-00aISO 11137-2ISO 10993, Part 10ISO 10993, Part 10ISO 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 (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,
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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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.
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Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription UsePer 21CFR 801.109 Subpart D | OR | Over-The-CounterPer 21CFR 801.109 Subpart C X |
|---|---|---|
| ------------------------------------------------- | ---- | ---------------------------------------------------------------------------------------------------- |
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K081027 |
|---|---|
| ---------------- | --------- |
§ 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.