(45 days)
A powder-free 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05. Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
The provided text describes the 510(k) premarket notification for "Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs" and includes information about the device's indications for use and performance related to chemotherapy drug permeation. Based on the document, I can extract the acceptance criteria and performance data for chemotherapy drug permeation. However, the document does NOT contain information about a study that would typically include details like sample size for test or training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established in the context of an AI/algorithm-based device. This document is a regulatory submission for a physical medical glove, not an AI/software device.
Therefore, I will only be able to populate the acceptance criteria and device performance table, and explain why other requested information is not applicable to this document.
Acceptance Criteria and Reported Device Performance
| No. | Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time (Minutes)) | Reported Device Performance (Breakthrough Detection Time (Minutes)) |
|---|---|---|---|
| 1 | Carboplatin (10.0 mg/ml) | >240 | >240 |
| 2 | Carmustine (BCNU) (3.3 mg/ml) | A specific minimum clinical threshold for breakthrough time would be the acceptance criteria. The document states a breakthrough time of 3.0 minutes, which is relatively low compared to others. | 3.0 |
| 3 | Cisplatin (1.0 mg/ml) | >240 | >240 |
| 4 | Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 | >240 |
| 5 | Cytarabine (100.0 mg/ml) | >240 | >240 |
| 6 | Dacarbazine (DTIC) (10.0 mg/ml) | >240 | >240 |
| 7 | Docetaxel (10.0 mg/ml) | >240 | >240 |
| 8 | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 | >240 |
| 9 | Etoposide (Toposar) (20.0 mg/ml) | >240 | >240 |
| 10 | Fluorouracil (50.0 mg/ml) | >240 | >240 |
| 11 | Mechlorethamine HCl (1.0 mg/ml) | >240 | >240 |
| 12 | Methotrexate (25.0 mg/ml) | >240 | >240 |
| 13 | Paclitaxel (Taxol) (6.0 mg/ml) | >240 | >240 |
| 14 | Thiotepa (10.0 mg/ml) | A specific minimum clinical threshold for breakthrough time would be the acceptance criteria. The document states a breakthrough time of 75.0 minutes, which is lower than many others. | 75.0 |
Note on Acceptance Criteria: For most drugs listed, the implied acceptance criterion is "greater than 240 minutes" of breakthrough detection time, as the device performance meets or exceeds this value for 12 out of 14 drugs. For Carmustine (BCNU) and Thiotepa, the document explicitly notes their "extremely low permeation time" and reports specific values (3.0 and 75.0 minutes, respectively). Therefore, the acceptance criteria for these specific drugs would be defined by the regulatory standard (ASTM D6978-05) and deemed acceptable given the specific performance measured.
Study Details (Information Not Applicable to this Document Type)
The provided document is a 510(k) clearance letter for a physical medical device (examination gloves). It describes the device's intended use and includes testing results for permeation by chemotherapy drugs, conducted in accordance with ASTM D6978-05 (Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs).
The questions you've asked (regarding sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set ground truth) are typically relevant for studies evaluating Artificial Intelligence (AI) or machine learning algorithms/devices.
Since this document pertains to a physical product (nitrile gloves) and its material properties, the concepts of "test set," "training set," "experts to establish ground truth," "adjudication method," "MRMC study," or "standalone (algorithm only) performance" are not applicable in this context. The "study" referenced is the physical permeation test conducted according to the ASTM standard, not a data-driven AI model evaluation.
Therefore, the requested details are not present in this document because they are not relevant to the type of device and evaluation described.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2013
Ms. Noorzaliza Ahmad Quality Assurance Executive HL Rubber Industries Sdn Bhd Lot 10, Kawasan Perindustrian Dioh Kuala Pilah Negeri Sembilan, Malaysia 72000
Re: K130038
Trade/Device Name: Powder-Free Nitrile Examination Gloves, Blue, 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: January 7, 2013 Received: January 29, 2013
Dear Ms. Ahmad:
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 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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Image /page/1/Picture/7 description: The image contains a stylized drawing with text and geometric shapes. The text appears to be a signature or inscription, with some words more legible than others. The geometric shapes include a series of stacked lines forming a triangular or mountain-like structure on the right side of the image. The overall style is abstract and appears to be hand-drawn.
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known): K130038
Device Name: Powder-Free Nitrile Examination Gloves, Blue, Tested for Use With Chemotherapy Drugs
Indications For Use: A powder-free 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.
In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05. Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| No. | Chemotherapy Drug and Concentration | Minimum BreakthroughDetection Time(Minutes) |
|---|---|---|
| l | Carboplatin ( 10.0 mg/ml) | >240 |
| 2 | Carmustine (BCNU) (3.3 mg/ml) | 3.0 |
| 3 | Cisplatin (1.0 mg/ml) | >240 |
| 4 | Cyclophosphamide (Cytoxan) (20.0 mg/ml). | >240 |
| 5 | Cytarabine (100.0 mg/ml) | >240 |
| б | Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| 7 | Docetaxel (10.0 mg/ml) | >240 |
| 8 | Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| ਰੇ | Etoposide (Toposar) (20.0 mg/ml) | >240 |
| 10 | Fluorouracil (50.0 mg/ml) | >240 |
| l I | Mechlorethamine HCI (1.0 mg/ml) | >240 |
| 12 | Methotrexate (25.0 mg/ml) | >240 |
| 13 | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 14 | Thiotepa (10.0 mg/ml) | 75.0 |
Please note that the following drugs have extremely low permeation time: Carmustine (BCNU) (3.3 mg/ml) has a minimum breakthrough time of 3.0 minute and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 75.0 minute.
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
| Elizabeth Laverie | |
|---|---|
| 2013.02.20 18:21:46 -05'00' |
Concurrence of CDRH, Office of Device Evaluation (ODE)(Division Sign-Off) Division Sign-Off)
Division of Anesthestology, General Hospital Infection Control, Dental Devices
| S10(k) Number: | K130038 |
|---|---|
| ---------------- | --------- |
§ 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.