(97 days)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs.
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White)
This document is a 510(k) premarket notification for Nitrile Powder Free Examination Gloves, tested for use with chemotherapy drugs, in blue, orange, and white colors. The primary purpose of this document is to establish substantial equivalence to legally marketed predicate devices and list the indications for use, specifically detailing their resistance to various chemotherapy drugs. This is not a study report demonstrating the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device cannot be extracted from this document.
The document provides information on the performance of the gloves against chemotherapy drugs, which involves breakthrough times. This is the closest analog to "acceptance criteria" and "device performance" in this context but is related to the physical properties of the gloves, not an AI/ML system.
I will attempt to structure the information based on the glove performance, but please be aware that it does not align with the requested information for an AI/ML study.
Acceptance Criteria and Performance (for the gloves' resistance to chemotherapy drugs):
The acceptance criterion, though not explicitly stated as "acceptance criteria," is the breakthrough time of the glove when exposed to chemotherapy drugs. The device "meets" this by demonstrating the reported breakthrough times, which are then used to inform users about the glove's suitability for different chemotherapy drugs. A longer breakthrough time indicates better protection. The FDA's acceptance of these values implies they are deemed sufficient for the stated indication.
1. Table of Acceptance Criteria and Reported Device Performance:
| Chemotherapy Drugs | Concentration (mg/ml) | Acceptance Criteria (Implicit: Higher is better, FDA approved these values) | Device Performance (Blue Glove) Breakthrough Time (minutes) | Device Performance (Orange Glove) Breakthrough Time (minutes) | Device Performance (White Glove) Breakthrough Time (minutes) |
|---|---|---|---|---|---|
| Carmustine | 3.3 | N/A (See note below table) | 0.1 | 20.3 | 20.4 |
| Cisplatin | 1.0 | N/A (See note below table) | >240 | >240 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | N/A (See note below table) | >240 | >240 | >240 |
| Dacarbazine | 10.0 | N/A (See note below table) | >240 | >240 | >240 |
| Doxorubixin Hydrochloride | 2.0 | N/A (See note below table) | >240 | >240 | >240 |
| Etoposide | 20.0 | N/A (See note below table) | >240 | >240 | >240 |
| Fluoroucil | 50.0 | N/A (See note below table) | >240 | >240 | >240 |
| Methotrexate | 25.0 | N/A (See note below table) | >240 | >240 | >240 |
| Mitomycin | 0.5 | N/A (See note below table) | >240 | >240 | >240 |
| Paclitaxel | 6.0 | N/A (See note below table) | >240 | >240 | >240 |
| Thiotepa | 10.0 | N/A (See note below table) | 20.4 | 50.6 | 71.0 |
| Vincristine Sulfate | 1.0 | N/A (See note below table) | >240 | >240 | >240 |
Note on Acceptance Criteria: For these types of medical devices (gloves), the "acceptance criteria" for chemical resistance testing are typically defined by regulatory standards (e.g., ASTM F739 - Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact). While the document does not explicitly state the specific acceptance thresholds, the FDA's clearance of the device indicates that the provided breakthrough times are considered acceptable for the intended use and for informing users about the limitations/capabilities of the gloves. The document "notes the following drugs Carmustine and Thiotepa have extremely low permeation times," which serves as an important user warning based on the test results.
The following numbered points (2-9) are irrelevant to this document as it concerns medical gloves, not an AI/ML device.
2. Sample size used for the test set and the data provenance: Not applicable. This document refers to chemical permeation testing, not a dataset for an AI/ML model. The "test set" in this context would be the gloves themselves subjected to chemical testing. No sample size information for these physical tests is provided in the document. Data provenance is not applicable for an AI/ML study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemical permeation is established through laboratory testing protocols, not expert consensus in the way an AI/ML study would use it.
4. Adjudication method for the test set: Not applicable. This pertains to expert review for AI/ML performance, not physical product testing.
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 for AI/ML performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI/ML performance evaluation.
7. The type of ground truth used: For the glove performance, the "ground truth" is the empirically measured breakthrough time determined by standardized laboratory methods (e.g., ASTM F739). This is an objective measurement, not expert consensus, pathology, or outcomes data in the context of an AI/ML device.
8. The sample size for the training set: Not applicable. There is no AI/ML training set mentioned or implied in this document.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set mentioned or implied in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2015
Hartalega NGC Sdn Bhd Nurul Aisyah Kong Senior Manager-quality Assurance C-G-9, Jalan Dataran SD1 Dataran SD PJU 9 Bandar Sri Damansara Kuala Lumpur 52200 Malaysia
Re: K151343
Trade/Device Name: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue, Orange, White) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: July 15, 2015 Received: July 20, 2015
Dear Ms. Aisyah Kong:
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.
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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 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 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151343
Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue)
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Blue) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are;
| Chemotherapy Drugs | Concentration (mg/ml) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine | 3.3 | 0.1 |
| Cisplatin | 1.0 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | >240 |
| Dacarbazine | 10.0 | >240 |
| Doxorubixin Hydrochloride | 2.0 | >240 |
| Etoposide | 20.0 | >240 |
| Fluoroucil | 50.0 | >240 |
| Methotrexate | 25.0 | >240 |
| Mitomycin | 0.5 | >240 |
| Paclitaxel | 6.0 | >240 |
| Thiotepa | 10.0 | 20.4 |
| Vincristine Sulfate | 1.0 | >240 |
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 0.1 and 20.4 minutes respectively.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
서 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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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."
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Indications for Use
510(k) Number (if known) K151343
Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Orange)
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (Orange) is non - sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are;
| Chemotherapy Drugs | Concentration (mg/ml) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine | 3.3 | 20.3 |
| Cisplatin | 1.0 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | >240 |
| Dacarbazine | 10.0 | >240 |
| Doxorubixin Hydrochloride | 2.0 | >240 |
| Etoposide | 20.0 | >240 |
| Fluoroucil | 50.0 | >240 |
| Methotrexate | 25.0 | >240 |
| Mitomycin | 0.5 | >240 |
| Paclitaxel | 6.0 | >240 |
| Thiotepa | 10.0 | 50.6 |
| Vincristine Sulfate | 1.0 | >240 |
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 20.3 and 50.6 minutes respectively.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
서 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{5}------------------------------------------------
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."
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Indications for Use
510(k) Number (if known) K151343
Device Name
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White)
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (White) is non -sterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs tested (with breakthrough times) are;
| Chemotherapy Drugs | Concentration (mg/ml) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine | 3.3 | 20.4 |
| Cisplatin | 1.0 | >240 |
| Cyclophosphamide (Cytoxan) | 20.0 | >240 |
| Dacarbazine | 10.0 | >240 |
| Doxorubixin Hydrochloride | 2.0 | >240 |
| Etoposide | 20.0 | >240 |
| Fluoroucil | 50.0 | >240 |
| Methotrexate | 25.0 | >240 |
| Mitomycin | 0.5 | >240 |
| Paclitaxel | 6.0 | >240 |
| Thiotepa | 10.0 | 71.0 |
| Vincristine Sulfate | 1.0 | >240 |
Please note the following drugs Carmustine and Thiotepa have extremely low permeation times of 20.4 and 71.0 minutes respectively.
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
서 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
{7}------------------------------------------------
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.