(145 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
The provided document is a 510(k) premarket notification decision letter from the FDA regarding Nitrile Blue Powder Free Examination Gloves. This document describes the regulatory classification and general controls applicable to the device, and importantly, includes the "Indications for Use" statement and a table of chemotherapy drug permeation test results.
Therefore, the acceptance criteria and study proving the device meets the acceptance criteria are related to the performance of the gloves against permeation by chemotherapy drugs, not an AI/ML algorithm or a diagnostic device, which is what the prompt's questions are geared towards.
Given the nature of the device (examination gloves) and the content of the document, most of the questions in the prompt are not applicable. The information provided is for a physical medical device, not a software or AI-based diagnostic tool.
However, I can extract information relevant to the performance claims and their supporting study as presented in the document, reinterpreting the prompt's questions for this context.
Here's an attempt to answer the questions based only on the provided document, acknowledging that most questions are designed for AI/ML or diagnostic devices and do not fit:
Device Under Evaluation: Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
1. A table of acceptance criteria and the reported device performance
For the specific claim "Tested for Use with Chemotherapy Drugs," the acceptance criterion is implied by the standard referenced (ASTM D6978-05) and the reported "Breakthrough Detection Time." While an explicit "acceptance criterion" value (e.g., must be > X minutes) is not stated in this document, the demonstration of high breakthrough times for most drugs indicates meeting a performance expectation set by the standard for protective gloves.
| Chemotherapy Drugs | Concentration | Reported Breakthrough Detection Time in Minutes | Implicit Acceptance Criterion (as demonstrated performance) |
|---|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml | 11.1 | Permeation Resistance Demonstrated |
| Cisplatin | 1.0mg/ml | > 240 | High Permeation Resistance |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 | High Permeation Resistance |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 | High Permeation Resistance |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 | High Permeation Resistance |
| Etoposide (Toposar) | 20.0mg/ml | > 240 | High Permeation Resistance |
| Fluorouracil | 50.0mg/ml | > 240 | High Permeation Resistance |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 | High Permeation Resistance |
| Thiotepa | 10.0mg/ml | 40.1 | Permeation Resistance Demonstrated |
| Amethopterin Hydrate | 25.0mg/ml | > 240 | High Permeation Resistance |
| Methotrexate | 25.0mg/ml | > 240 | High Permeation Resistance |
| Mitomycin C | 0.5mg/ml | > 240 | High Permeation Resistance |
| Vincristine Sulfate | 1.0mg/ml | > 240 | High Permeation Resistance |
2. Sample size used for the test set and the data provenance
The document references "ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard would specify the sample size requirements (e.g., number of gloves tested per drug). This specific document does not state the sample size used for the permeation tests.
- Data Provenance: The tests were conducted according to a recognized ASTM standard, implying a controlled laboratory setting. The country of origin of the data is not specified, but the applicant (GMP MEDICARE SDN.BHD.) is based in Malaysia ("MY"). The testing would typically be done in a lab, which could be internal or external.
- Retrospective or Prospective: Not applicable in the context of physical product testing. These are laboratory characterization tests on manufactured samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and study. The "ground truth" for chemical permeation is established by the standardized test method (ASTM D6978-05) itself, which involves specialized laboratory equipment and procedures, not human expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve disagreements in expert interpretations (e.g., in medical image reading). This study involves objective chemical permeation measurements.
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 document is about a physical product (gloves) and their chemical resistance, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to the standalone performance of an algorithm. The "device" here is a pair of gloves. The performance (breakthrough time) is inherently "standalone" in the sense that it's a direct measurement of the glove material properties, not an assisted human process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims would be the objective measurements obtained according to ASTM D6978-05. This standard defines how permeation is measured and what constitutes a "breakthrough detection time." It's a direct physical measurement/test outcome, not an interpretation from experts, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of physical medical device performance testing like chemical permeation. This concept applies to machine learning models.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
{0}------------------------------------------------
Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2017
GMP MEDICARE SDN.BHD. Eva Vinoni Mustafa OA Senior Manager Lot/pt64593, Jln Dahlia/ku8, Kaw Perindustrian Meru Timur Klang, 41050 MY
Re: K163017
Trade/Device Name: Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: February 21, 2017 Received: February 21,2017
Dear Eva Vinoni Mustafa:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K163017
Device Name
Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drugs Permeation (Breakthrough Detection Time) in Minutes The following chemicals have been tested with these gloves.
| Chemotherapy Drugs | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carmustine (BCNU) | 3.3mg/ml | 11.1 |
| Cisplatin | 1.0mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0mg/ml | > 240 |
| Dacarbazine (DTIC) | 10.0mg/ml | > 240 |
| Doxorubicin Hydrochloride | 2.0mg/ml | > 240 |
| Etoposide (Toposar) | 20.0mg/ml | > 240 |
| Fluorouracil | 50.0mg/ml | > 240 |
| Paclitaxel (Taxol) | 6.0mg/ml | > 240 |
| Thiotepa | 10.0mg/ml | 40.1 |
| Amethopterin Hydrate | 25.0mg/ml | > 240 |
| Methotrexate | 25.0mg/ml | > 240 |
| Mitomycin C | 0.5mg/ml | > 240 |
| Vincristine Sulfate | 1.0mg/ml | > 240 |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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.