(93 days)
The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 minutes, respectively.
Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs
The provided document is a 510(k) premarket notification letter from the FDA to Hartalega Sdn. Bhd. for "Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs."
This document does not contain information about an AI/ML device or a study proving its performance against acceptance criteria. Instead, it details the FDA's clearance of a medical device (examination gloves) based on a determination of substantial equivalence to a predicate device.
The "acceptance criteria" discussed in the document relate to the gloves' permeation resistance to chemotherapy drugs, which is a functional performance metric, not an AI/ML diagnostic or predictive metric. The study mentioned is a "Permeation Test" for these gloves, not a clinical study involving human readers or AI algorithms as described in your request.
Therefore, I cannot fulfill your request using the provided text because it does not describe an AI/ML device or a study of that nature.
Here's a breakdown of why this document doesn't fit your prompt:
- No AI/ML Device: The device is "Nitrile Powder Free Examination Gloves (Orange)". There is no mention of any artificial intelligence, machine learning, software, or algorithm.
- No Acceptance Criteria for AI/ML Performance: The acceptance criteria are "Minimum Breakthrough Time" for various chemotherapy drugs, which are physical properties of the gloves.
- No Study of AI/ML Performance: The "study" referenced is a "Permeation Test", which assesses how long it takes for chemotherapy drugs to permeate the glove material.
- No Sample Size for Test Set (AI/ML): Not applicable.
- No Data Provenance (AI/ML): Not applicable.
- No Experts for Ground Truth (AI/ML): Not applicable.
- No Adjudication Method (AI/ML): Not applicable.
- No Multi Reader Multi Case (MRMC) Study: Not applicable.
- No Standalone Performance (AI/ML): Not applicable.
- No Ground Truth Type (AI/ML): Not applicable.
- No Training Set Sample Size (AI/ML): Not applicable.
- No How Ground Truth for Training Set Established (AI/ML): Not applicable.
The table provided in the document ("Permeation Test Results of Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs") shows the results of the permeation tests against the implied criteria of preventing breakthrough within a certain timeframe (or demonstrating the breakthrough time).
If you have a document describing an AI/ML medical device and its performance study, I would be happy to analyze it according to your requested format.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Hartalega Sdn. Bhd. Ms. Nurul Aisyah Kong Binti Abdullah Quality Assurance Senior Manager No. 7 Kawasan Perusahaan Suria Bestari Jaya Selangor Darul Ehsan 45600 MALAYSIA
Re: K150103
Trade/Device Name: Nitrile Powder Free Examination Gloves (Orange) 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: March 18, 2015 Received: March 23, 2015
Dear Ms. Abdullah:
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 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 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/Resourcesfor You/Industry/default.htm. 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/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 Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K150103
Device Name
Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs is a non-sterile disposable device intended for medical and dental purpose that is wor on the examiners hand to prevent contraniation total weather and examiner. It is also tested to be assess of the list of Chemotherapy Drugs tested (with breakthrough times) as per attached table. Please note that Carmustine and Thiotepa have externely low permeation times of 45.4 minutes and 30.9 minutes, respectively.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
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Permeation Test Results of Nitrile Powder Free Examination Gloves (Orange) Tested for Use with Chemotherapy Drugs.
| Chemotherapy Drugs | Minimum Breakthrough Time(Minutes) |
|---|---|
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | 45.4 |
| Cisplatin1.0 mg/ml (1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan)20 mg/ml (20,000 ppm) | > 240 |
| Dacarbazine (DTIC)10.0 mg/ml ( 10,000 ppm) | > 240 |
| Doxorubicin Hydrochloride2.0 mg/ml (2,000 ppm) | > 240 |
| Etoposide (Toposar)20.0 mg/ml (20,000 ppm) | > 240 |
| Fluorouracil50.0 mg/ml (50,000 ppm) | > 240 |
| Ifosfamide50.0 mg/ml (50,000 ppm) | > 240 |
| Methotrexate25.0 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone2.0 mg/ml (2,000 ppm) | > 240 |
| Paclitaxel (Taxol)6.0 mg/ml (6,000 ppm) | > 240 |
| Thiotepa10.0 mg/ml (10,000 ppm) | 30.9 |
| Vincristine Sulfate1.0 mg/ml (1,000 ppm) | > 240 |
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§ 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.