(48 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 tested for use with chemotherapy drugs.
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document, K092327, details the 510(k) summary for Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use). This is a submission for a medical device (examination gloves), which typically uses performance standards and bench testing rather than clinical studies with human participants or AI algorithms. As such, many of the requested categories (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone algorithm performance, adjudication methods) are not applicable to this type of submission.
Here's a breakdown of the requested information based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Characteristics | Standard (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a(2005) - Standard Specification for Nitrile Examination Gloves for Medical Application (Implicitly, the dimensional requirements within this standard) | Meets |
| Physical Properties | ASTM D 6319-00a(2005) - Standard Specification for Nitrile Examination Gloves for Medical Application (Implicitly, tensile strength, elongation, etc.) | Meets |
| Freedom from Holes / Holes | ASTM D 6319-00a(2005) (General requirement) and ASTM D 5151-06 (Specific test method for freedom from holes) | Meets |
| Powder-Free | ASTM D 6124-06 (Standard test method for residual powder on medical gloves) | ≤2 mg per glove (meets the standard's requirements for powder-free) |
| Biocompatibility | ISO Skin Irritation Study | Passes |
| ISO Maximization Sensitization Study | Passes | |
| Extract Cytotoxicity Study Using the End-Point Titration Method | Non-toxic at 24 hours for dilutions 1:2 through 1:32 | |
| Chemotherapy Drug Permeation Test | ASTM D 6978-05 (Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs) | Chemotherapy Drug Permeation (average breakthrough time in minutes):- Carmustine: 45.27- Cyclophosphamide: >240- Doxorubicin Hydrochloride: >240- Etoposide (Toposar): >240- 5-Fluorouracil: >240- Paclitaxel (Toxol): >240- Thio-Tepa: 93.50- Vincristine Sulfate: >240- Methotrexate: >240 |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance data based on adherence to ASTM and ISO standards for examination gloves. These tests typically involve statistical sampling from manufacturing lots according to the respective standard's requirements. The document does not specify the exact sample sizes used for each test or the data provenance (e.g., country of origin) beyond stating these are "non-clinical tests." The nature of these tests (e.g., physical property testing, chemical permeation) means samples are taken from product batches, not human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for glove performance characteristics is established by objective measurements against recognized industry standards (ASTM, ISO) and laboratory testing, not by expert consensus on clinical or imaging data.
4. Adjudication Method for the Test Set
Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is irrelevant for objective physical and chemical property testing of examination gloves.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. These studies are typically used to evaluate the impact of AI on human reader performance for tasks like image interpretation, which is not relevant for examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an physical examination glove, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" is based on objective measurements against established performance standards and test methodologies (e.g., ASTM D 6319-00a(2005) for dimensions and physical properties, ASTM D 5151-06 for holes, ASTM D 6124-06 for powder, ISO studies for biocompatibility, and ASTM D 6978-05 for chemotherapy drug permeation).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a training set. The performance data is derived from testing physical product samples.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device like examination gloves.
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1635 Industrial Road Dothan, AL 36303 Tel: (334) 615-2563 Fax: (334) 615-2574
510(k) SUMMARY
1.0 Submitter:
Ansell Healthcare Products LLC 1635 Industrial Road Dothan, AL 36303
2.0 Contact Information:
Cynthia A. Ingram, Regulatory Affairs Manager, Americas Telephone: (334) 615-2563 Fax: (334) 615-2568
SEP 2 1 2009
3.0 Name of Device:
Trade Name: Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use)
Patient Examination Gloves Common Name:
Classification Name: Glove, Patient Examination, Nitrile
- 4.0 Identification of the Device:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the requirements of ASTM D 6319-00a(2005).
5.0 Description of the Device:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) meet all of the current specifications of ASTM D6319-00a(2005), Standard Specification for Nitrile Examination Gloves for Medical Application.
6.0 Intended Use of the Device:
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.
7.0 Summary of Technological Characteristics of the Device:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
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| Characteristics | Standard | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-00a(2005) | Meets |
| Physical Properties | ASTM D 6319-00a(2005) | Meets |
| Freedom fromHoles | ASTM D 6319-00a(2005) | Meets |
| Holes | ASTM D 5151-06 | Meets |
| Powder-Free | ASTM D 6124-06 | ≤2 mg per glove |
| Biocompatibility | ISO Skin Irritation Study | Passes |
| ISO MaximizationSensitization Study - ExtractCytotoxicity Study Using theEnd-Point Titration Method | PassesNon-toxic at 24 hours fordilutions 1:2 through 1:32 | |
| ChemotherapyDrugPermeation Test | ASTM D 6978-05 | Chemotherapy Drug Permeation(average breakthrough time inminutes)Carmustine 45.27Cyclophosphamide >240Doxorubicin Hydrochloride >240Etoposide (Toposar) >2405-Fluorouracil >240Paclitaxel (Toxol) >240Thio-Tepa 93.50Vincristine Sulfate >240Methotrexate >240 |
8.0 Substantial Equivalence Based on Assessment of Non-Clinical Performance Data:
The performance test data of the non-clinical tests are the same as mentioned immediately above.
9.0 Substantial Equivalence Based on Assessment of Clinical Performance Data:
Clinical data is not needed for medical gloves or for most devices cleared by the 510(k) process.
10.0 Conclusion:
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 performance standards referenced in Section 7 above and therefore meet:
ASTM listed standards, FDA hole requirements, and labeling claims for the product.
This device is substantially equivalent to currently marketed devices.
This summary will include any other information reasonably deemed necessary by the FDA.
2
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ansell Healthcare Products LLC C/O Mr. Casey Conry Responsible Third Party Official Underwriters Laboratories. Incorporated 1285 Walt Whitman Road Melville, New York 11747
Re: K092327
Trade/Device Name: Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves, Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I . Product Code: LZA, LZC Dated: September 4, 2009
Received: September 8, 2009
Dear Mr. Conry:
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 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. Conry
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance, Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reporta Problem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D. Archer
Susan Runner, D.D.S., M.A. Acting 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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3.0 Indications for Use Statement:
INDICATIONS FOR USE
510(K) Number (if known): K092327
Device Name:
Micro-Touch® NitraFree™ Nitrile Powder-Free Pink Examination Gloves, Tested for Use with Chemotherapy Drugs
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 tested for use with chemotherapy drugs.
Chemotherapy Drug Permeation (average breakthrough detection time in minutes) (ASTM D6978-05)
AND/OR
| *Carmustine | 45.27 |
|---|---|
| Cyclophosphamide | >240 |
| Doxorubicin Hydrochloride | >240 |
| Etoposide (Toposar) | >240 |
| 5-Fluorouracil | >240 |
| Paclitaxel (Toxol) | >240 |
| Thio-Tepa | 93.50 |
| Vincristine Sulfate | >240 |
| Methotrexate | >240 |
*Caution: Testing showed an average breakthrough time of 45 minutes with Carmustine.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use X (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)
Shula A. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K192327
§ 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.