(89 days)
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, 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
The provided text describes the acceptance criteria and the study conducted for the Kimberly-Clark* STERLING* Nitrile & STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim. This information is from a Traditional 510(k) summary filed with the FDA.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Test | Standard | Acceptance Criteria / Reported Performance |
|---|---|---|
| Non-Clinical Tests | ||
| Dimensions | ASTM D 6319-00a | Meets |
| Physical Properties | ASTM D 6319-00a | Meets |
| Freedom from pinholes | ASTM D 6319-00aASTM D 5151-06 | Meets |
| Powder Free | ASTM D 6124-06ASTM 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 |
| Resistance to Permeation (Protective Clothing) | ASTM F 739-07 | See data below (specific breakthrough times reported for various chemotherapy drugs) |
| Resistance to Permeation (Medical Gloves) | ASTM D 6978-05 | See data below (specific breakthrough times reported for various chemotherapy drugs) |
| Chemotherapy Drug Permeation (Average Breakthrough Detection Time in minutes) | ||
| Cyclophosphamide (20.0 mg/ml) | No breakthrough up to 240 minutes | |
| Doxorubicin HCI (2.0 mg/ml) | No breakthrough up to 240 minutes | |
| Etoposide (20.0 mg/ml) | No breakthrough up to 240 minutes | |
| 5-Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 minutes | |
| Paclitaxel (Taxol) (6.0 mg/ml) | No breakthrough up to 240 minutes | |
| ThioTEPA (10.0 mg/ml) | Avg. minutes before breakthrough = 54.2 | |
| Cisplatin (1.0 mg/ml) | No breakthrough up to 240 minutes | |
| Dacarbazine (10.0 mg/ml) | No breakthrough up to 240 minutes | |
| Ifosfamide (50.0 mg/ml) | No breakthrough up to 240 minutes | |
| Mitoxantrone (2.0 mg/ml) | No breakthrough up to 240 minutes | |
| Vincristine sulfate (1.0 mg/ml) | No breakthrough up to 240 minutes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each of the specific non-clinical tests (e.g., number of gloves tested for pinholes, dimensions, or physical properties). For the chemotherapy drug permeation tests, it lists "Average Breakthrough Detection Time," implying multiple tests were conducted for each drug, but the exact number of samples for each is not specified.
The data provenance is not mentioned (e.g., country of origin). The testing would be considered prospective in the sense that the tests were conducted specifically to demonstrate compliance for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a medical glove, not an AI/imaging device requiring expert consensus for ground truth. The "ground truth" for the device's performance is established by the standardized test methods themselves and the quantitative results obtained from those tests. Therefore, experts in establishing "ground truth" in the context of diagnostic interpretation are not applicable here. The experts involved would be those qualified to execute the specific ASTM and ISO standards for glove testing and biocompatibility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation (e.g., in diagnostic imaging or clinical trials) where disagreements in judgment need to be resolved to establish ground truth. For this type of product and testing, the results are objectively measured per the specified 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 is not an AI-assisted diagnostic or interpretation device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical glove, not an algorithm. The "standalone performance" is essentially the results of the physical and chemical tests conducted on the glove itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of these gloves is based on:
- Standardized Test Methods: Adherence to established and recognized industry standards like ASTM D 6319-00a, ASTM D 5151-06, ASTM D 6124-06, ASTM F 739-07, ASTM D 6978-05.
- Biocompatibility Standards: Compliance with ISO 10993 (Parts 10 and 11) for skin irritation, sensitization, and systemic toxicity.
- Quantitative Measurements: Direct measurements of physical properties (dimensions, tensile strength, elasticity), freedom from defects (pinholes), powder content, and breakthrough times for specific chemotherapy drugs.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As this device does not use a training set, the establishment of ground truth for such a set is irrelevant.
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Image /page/0/Picture/1 description: The image shows the logo for Kimberly-Clark Corporation. The logo consists of a circular symbol with a stylized "K" inside, followed by the text "Kimberly-Clark Corporation" in a bold, sans-serif font. The text is black, and the circular symbol is also black.
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Traditional 510(k) for Kimberly-Clark* STERLING* Nitrile & STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim
Section 5. 510(k) SUMMARY
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: | July 10, 2008 |
| Name of Device | |
| Trade Name: | |
| Common Name: | |
| Classification Name: | Glove, Patient Examination, Specialty - 80 LZC |
| Legally marketed deviceto which equivalency isclaimed: | Kimberly-Clark* STERLING* Nitrile Powder-Free Exam Glove - K051347 Perusahaan Getah Asas Sdn. Bhd. Powdered Free Patient ExaminationGloves, Blue Colored Non-Sterile (Low Dermatitus Potential andChemotherapy Drug Protection Labeling Claims) - K042805 |
| Description of the device: | Light gray nitrile, chlorinated, powder-free, textured fingertip, ambidextrouspatient examination glove that meets all of the requirements of ASTMD 6319-00a, Standard Specification for Nitrile Examination Gloves for MedicalApplication |
| Intended use of device: | The Kimberly-Clark* STERLING* Nitrile and Nitrile-Xtra* Powder-FreeExam Gloves are disposable devices intended for medical purposes that areworn on the examiner's hand to prevent contamination between patient andexaminer. |
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Traditional 510(k) for Kimberly-Clark* STERLING* Nitrile & STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim
| Summary of technologicalcharacteristics comparedto predicate device: | There are no different technological characteristics compared to the predicatedevices. They are all powder-free non-sterile nitrile exam gloves, one predicatea gray color and the other a blue color. The Chemotherapy Drug Use Claim issimilar to that of Perusahaan Getah Asas Sdn. Bhd. Powdered Free PatientExamination Gloves, Blue Colored Non-Sterile (Low Dermatitis Potential andChemotherapy Drug Protection Labeling Claims) - K042805 | ||
|---|---|---|---|
| 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 6319-00aASTM D 5151-06 | Meets | |
| Powder Free | ASTM D 6124-06ASTM 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 | |
| Resistance to Permeation(Protective Clothing) | ASTM F 739-07 | See data below | |
| Resistance to Permeation(Medical Gloves) | ASTM D 6978-05 | See data below | |
| Tested Chemotherapy Drug andConcentration | Average Breakthrough Detection Time(minutes) | ||
| Cyclophosphamide (20.0 mg/ml) | No breakthrough up to 240 minutes | ||
| Doxorubicin HCI (2.0 mg/ml) | No breakthrough up to 240 minutes | ||
| Etoposide (20.0 mg/ml) | No breakthrough up to 240 minutes | ||
| 5-Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 minutes | ||
| Paclitaxel (Taxol) 6.0 mg/ml) | No breakthrough up to 240 minutes | ||
| ThioTEPA (10.0 mg/ml) | Avg. minutes before breakthrough = 54.2 | ||
| Cisplatin (1.0 mg/ml) | No breakthrough up to 240 minutes | ||
| Dacarbazine (10.0 mg/ml) | No breakthrough up to 240 minutes | ||
| Ifosfamide (50.0 mg/ml) | No breakthrough up to 240 minutes | ||
| Mitoxantrone (2.0 mg/ml) | No breakthrough up to 240 minutes | ||
| Vincristine sulfate (1.0 mg/ml) | No breakthrough up to 240 minutes | ||
| 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* STERLING* Nitrile and Nitrile-Xtra* Powder-FreeExam Gloves Kimberly-Clark* STERLING* meets all applicable performanceand biocompatibility requirements. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure with stylized wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 4 2008
Mr. Richard V. Wolfe Associate Director, Regulatory Affairs Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, Georgia 30076
Re: K081089
Trade/Device Name: Kimberly-Clark* STERLING* Nitrile and STERLING* Nitrile-Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: June 27, 2008 Received: July 2, 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-{See Below For Phone Numbers]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
. Sincerely yours,
Anthony D. Watson for
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
- Applicant: Kimberly-Clark Corporation 510(k) Number: K081089 Kimberly-Clark* STERLING* Nitrile and STERLING* Nitrile-Device Name: Xtra* Powder-Free Exam Gloves with a Chemotherapy Drug Use Claim 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21CFR 801.109 Subpart D Over-The-Counter Per 21CFR 801.109 Subpart C
×
Tula N. Murphy, L.S.
OR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K811899
§ 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.