(31 days)
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
The powder free neon nitrile exam glove is a medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient. The powder free neon nitrile exam glove possesses the following technological characteristics (as compared to ASTM or equivalent standards): Dimensions Meets ASTM D 3578-00, Physical Properties (except % elongation) Meets ASTM D 3578-00, Freedom from pinholes Meets ASTM D 3578-00 Meets ASTM D 5151-99, Powder Free Meets ASTM D 6124-00 Meets ASTM D 3578-00. Biocompatability: Primary Skin Irritation in Rabbits Passes, Guinea Pig Sensitization Passes.
This document describes the premarket notification (510(k)) for the Kimberly-Clark "Safeskin Neon Nitrile" Powder Free Neon Nitrile Exam Glove. It outlines the acceptance criteria and performance of the device based on established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3578-00 | Meets ASTM D 3578-00 |
| Physical Properties (except % elongation) | ASTM D 3578-00 | Meets ASTM D 3578-00 |
| Freedom from pinholes | ASTM D 3578-00 and ASTM D 5151-99 | Meets ASTM D 3578-00, Meets ASTM D 5151-99 |
| Powder Free | ASTM D 6124-00 and ASTM D 3578-00 | Meets ASTM D 6124-00, Meets ASTM D 3578-00 |
| Biocompatibility: Primary Skin Irritation in Rabbits | (Implied "Passes" for safety) | Passes |
| Biocompatibility: Guinea Pig Sensitization | (Implied "Passes" for safety) | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for testing each characteristic. However, the tests are conducted in accordance with ASTM standards (e.g., ASTM D 3578-00, ASTM D 5151-99, ASTM D 6124-00), which would typically specify sample sizes for robust testing.
The data provenance is not specified in terms of country of origin, but the testing would have been conducted by Kimberly-Clark or an accredited lab on their behalf. The data is retrospective in the sense that the tests were performed on finished product samples prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and study. The "ground truth" for glove performance is established by standardized testing protocols outlined in ASTM standards, not by expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results where expert agreement is needed to establish ground truth. For medical gloves, performance is objectively measured against specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, and the effect of AI on their performance is being evaluated. This device is an examination glove, and its effectiveness is determined by its physical and chemical properties, not by human interpretation of its output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the device's performance is standalone. The tests performed (e.g., dimensions, physical properties, freedom from pinholes, powder-free status, biocompatibility) are objective measurements of the glove itself, without human intervention in its function. The "algorithm" here is the glove's design and manufacturing process, and its performance is assessed directly.
7. The Type of Ground Truth Used
The ground truth used is established by objective, standardized measurements and criteria defined within recognized industry standards, specifically ASTM standards (e.g., ASTM D 3578-00, ASTM D 5151-99, ASTM D 6124-00). For biocompatibility, the ground truth is established through standard biological evaluation tests (e.g., primary skin irritation, guinea pig sensitization) designed to assess material safety.
8. The Sample Size for the Training Set
This information is not applicable. Medical gloves do not typically involve "training sets" in the context of machine learning or AI algorithms. The design and manufacturing processes are refined through engineering and material science, not through iterative training on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" in the context of this device. The physical and chemical properties of the glove materials and manufacturing processes are developed based on established scientific principles and prior knowledge of material performance and regulatory requirements.
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3 Kimberly-Clark
JUL - 5 2001
May 31, 2001
- 510(k) Summary of Safety and Effectiveness Information [1]
- [2] Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076
| Telephone: | 770-587-8000 |
|---|---|
| Fax: | 770-587-7762 |
Contact: Marcia Johnson Telephone: 770-587-8324 770-587-7762 Fax:
- [3] Trade Name: "Safeskin Neon Nitrile" -- Powder Free Neon Nitrile Exam Glove Common Name: Patient Examination Gloves Classification Name: Patient Examination Gloves
- [4] The predicate device is a Class I, poly-coated purple nitrile examination glove 80 LZA that meets all of the requirements of ASTM D 3578-00, Standard Specification for Rubber Examination Gloves for Medical Application (with the exception of elongation).
- [૨] The powder free neon nitrile exam glove will meet all of the requirements of ASTM D 3578-00, Standard Specification for Rubber Examination Gloves for Medical Application (with the exception of elongation).
- [୧] The powder free neon nitrile exam glove is a medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
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Professional Health Care
3 Kimberly-Clark
- The powder free neon nitrile exam glove possesses the following technological [7] characteristics (as compared to ASTM or equivalent standards):
| Characteristics | Standards |
|---|---|
| Dimensions | Meets ASTM D 3578-00 |
| Physical Properties(except % elongation) | Meets ASTM D 3578-00 |
| Freedom from pinholes | Meets ASTM D 3578-00Meets ASTM D 5151-99 |
| Powder Free | Meets ASTM D 6124-00Meets ASTM D 3578-00 |
Biocompatability
| Primary Skin Irritation in Rabbits | Passes |
|---|---|
| Guinea Pig Sensitization | Passes |
-
[8] The performance test data that support a determination of substantial equivalence are described above.
Clinical data are not needed for examination gloves. [9] -
It can be concluded that the powder free neon nitrile exam glove will perform [10] according to the glove performance standards referenced in Section 7 above and therefore will meet FDA requirements and the labeling claims for the product. In addition, this device is substantially equivalent to currently marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of an eagle with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2001
Ms. Marcia Johnson Senior Regulatory Associate Kimberely-Clark Corporation 1400 Holcomb Bridge Road Boswell, Georgia 30076
Re : K011713 Safeskin Neon Nitrile- Powder Trade/Device Name: Free Neon Examination Gloves Requlation Number: 880.6250 Requlatory Class: I Product Code: LZA Dated: May 31, 2001 June 4, 2001 Received:
Dear Ms. Johnson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 - Ms. Johnson
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
A. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Kimberly-Clark Corporation Applicant:
510(k) Number:
Device Names:
KO11713
Powder Free Neon Nitrile Exam Glove
Indications for Use:
A medical glove intended to be worn on the hands of healthcare and similar personnel to prevent contamination between such personnel and the patient.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Over-The-Counter
Qiss S. Lin
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number _
B2
§ 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.