(113 days)
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
The acceptance criteria and reported device performance for the Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are detailed below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a(2005) | Meets ASTM D 6319-00a(2005) |
| Physical Properties | ASTM D 6319-00a(2005) | Meets ASTM D 6319-00a(2005) |
| Freedom from Holes | ASTM D 6319-00a(2005) and ASTM D 5151-06 | Meets ASTM D 6319-00a(2005) and Meets ASTM D 5151-06 |
| Powder-Free | Powder content ≤ 2 mg per glove | Powder content ≤ 2 mg per glove |
| Biocompatibility: | ||
| ISO Skin Irritation Study | Passes | Passes |
| ISO Maximization Sensitization Study - Extract | Passes | Passes |
| Cytotoxicity Study Using the End-Point Titration Method | Non-toxic at 24 hrs. for dilutions 1:2 through 1:32 | Non-toxic at 24 hrs. for dilutions 1:2 through 1:32 |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the test sets for each characteristic. The performance data is presented as meeting specific ASTM standards or defined criteria (e.g., powder content, biocompatibility outcomes). The data provenance is not specified, but it can be inferred that these are standard in-house or contract lab tests performed to confirm compliance with regulatory and standard requirements. The tests are non-clinical ([8]).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a medical glove, and its performance is evaluated against engineering and biological standards, not against "ground truth" established by experts in the context of diagnostic interpretation. The evaluation relies on laboratory testing and measurements.
4. Adjudication method for the test set
This information is not applicable for this type of device and testing. Performance is measured against objective standards, not subjective interpretations requiring adjudication.
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
This information is not applicable as the device is a medical glove, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a medical glove, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by conformance to recognized industry standards (ASTM) and accepted biological testing protocols (ISO). For example:
- Physical properties (dimensions, tensile strength) are "true" if they fall within the specified ranges of ASTM D 6319-00a(2005).
- Freedom from holes is "true" if it meets the criteria of ASTM D 6319-00a(2005) and ASTM D 5151-06.
- Biocompatibility is "true" if the tests (ISO Skin Irritation, ISO Maximization Sensitization, Cytotoxicity) yield "Passes" or "Non-toxic" results as defined.
8. The sample size for the training set
This information is not applicable. The device is a manufactured product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" for this device.
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Ansel
JUN 1 9 2008
- [1] 510(k) SUMMARY
- [2] Ansell Healthcare Products LLC 1635 Industrial Road Dothan, AL 36303
Contact: Lon D. McIlvain, Vice President Regulatory and Quality Affairs Global Telephone: (334) 615-2562 Fax: (334) 615-2568
February 26, 2008
- [3] Trade Name: Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use)
Common Name: Examination Gloves
Classification Name: Glove, Patient Examination, Nitrile
- [4] Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
- Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves [ર] (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
- [6] Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are non-sterile disposable devices to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
- Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves [7] (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
| Characteristics | Standard |
|---|---|
| Dimensions | Meets ASTM D 6319-00a(2005) |
| Physical Properties | Meets ASTM D 6319-00a(2005) |
| Freedom from Holes | Meets ASTM D 6319-00a(2005)Meets ASTM D 5151-06 |
| Powder-Free | Powder content ≤ 2 mg per glove |
| Biocompatibility:ISO Skin Irritation StudyISO Maximization Sensitization Study - ExtractCytotoxicity Study Using the End-PointTitration Method | PassesPassesNon-toxic at 24 hrs.for dilutions 1:2 through1:32 |
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- [8] The performance test data of the non-clinical tests are the same as mentioned immediately above.
- [0] Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
- It is concluded that Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination
Gloves (Chemotherapy Use) are as safe, as effective, and perform as well as the glove [10] performance standards referenced in Section 7 above and therefore meet:
ASTM listed standards. FDA hole requirements, and labeling claims for the product.
- This summary will include any other information reasonably deemed necessary by the [1] FDA.
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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 stylized depiction of an eagle or bird with three wing-like strokes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2008
Mr. Lon D. McIlvain Vice president Regulatory and Quality Affairs Global Ansell Healthcare Products, LLC 1635 Industrial Road Dothan, Alabama 36303
Re: K080536
Trade/Device Name: Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: June 3, 2008 Received: June 4, 2008
Dear Mr. McIlvain:
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 vour 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. McIlvain
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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Suette Y. Michie MD.
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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INDICATIONS FOR USE
510(K) Number (if known):
Device Name:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use)
Indications For Use:
This is a medical glove to be worn on the hands of health care and similar personnel to prevent contamination between health care personnel and the patient's body, fluids, waste or environment and for use in handling chemotherapy drugs.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Shule A Mughts
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080536
§ 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.