(220 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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
The provided document is a 510(k) premarket notification for "Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, And Tested For Use With Chemotherapy Drugs." This is a medical device, and the information supplied primarily concerns its regulatory approval and performance against specific chemical permeation standards, rather than the performance of an AI/ML powered device.
Therefore, many of the requested categories for AI/ML device evaluations (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size of AI assistance, standalone performance, and ground truth establishment methods) are not applicable to this type of device and document.
However, I can extract the acceptance criteria and reported performance related to its intended use and testing for chemotherapy drug permeation.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the reported "Minimum Breakthrough Detection Time" for each chemotherapy drug, which are measured according to ASTM D6978-05. Higher breakthrough detection times indicate better performance (i.e., less permeation). While no explicit "acceptance limit" or "pass/fail" threshold is given in the document, the reported values are the established performance of the device against the standard.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time - Implied) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | N/A (Standard based on ASTM D6978-05) | 9.1 |
| Cisplastin (1.0 mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
| Cyclophosphamide (20 mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
| Dacarbazine (DTIC) (10.0mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
| Doxorubicin HCL (2.0mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
| Etoposide (Toposar) (20 mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
| Fluorouracil (50mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
| Methotrexate (25 mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
| Mitomycin C (0.5 mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
| Thiotepa (10 mg/ml) | N/A (Standard based on ASTM D6978-05) | 36.3 |
| Vincristine Sulfate (1 mg/ml) | N/A (Standard based on ASTM D6978-05) | >240 |
Note: The document explicitly states: "Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 9.1 and 36.3 minutes respectively." This serves as a warning regarding the performance for these specific drugs.
The following questions are not applicable to this document as it pertains to a manual medical device (gloves) and not an AI/ML powered device:
- 2. Sample sized used for the test set and the data provenance - Not applicable. Performance is based on standardized testing procedures (ASTM D6978-05) for chemical permeation, not a data-driven test set of patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts - Not applicable. The ground truth for chemical permeation is determined by laboratory measurements according to the ASTM standard, not by expert consensus on clinical data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc) - The "ground truth" here is the physical measurement of chemical permeation obtained through laboratory testing methods as defined by ASTM D6978-05.
- 8. The sample size for the training set - Not applicable. This is a physical device, not an AI model requiring a training set.
- 9. How the ground truth for the training set was established - Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
Shandong Feiyang Professional Gloves Co., Ltd % Xiaofei Hao Official Correspondent Basic Medical Industries. Inc. 805 Barrington Ave Ontario, California 91764
Re: K170136
Trade/Device Name: Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, 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: July 28, 2017 Received: August 1, 2017
Dear Xiaofei Hao:
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
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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 (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 (DICE) 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 (DICE) 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,
Tara A. Ryan -S
for Lori Wiggins, MPT, CLT Acting 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known) K170136
Device Name
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug and Concentration | Minimum Breakthrough DetectionTime (Minutes) | |
|---|---|---|
| 1. | Carmustine (BCNU)(3.3 mg/ml) | 9.1 |
| 2. | Cisplastin, (1.0 mg/ml) | >240 |
| 3. | Cyclophosphamide (20 mg/ml) | >240 |
| 4. | Dacarbazine (DTIC) (10.0mg/ml) | >240 |
| 5. | Doxorubicin HCL (2.0mg/ml) | >240 |
| 6. | Etoposide (Toposar) (20 mg/ml) | >240 |
| 7. | Fluorouracil (50mg/ml) | >240 |
| 8. | Methotrexate (25 mg/ml) | >240 |
| 9. | Mitomycin C (0.5 mg/ml) | >240 |
| 10. | Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| 11. | Thiotepa (10 mg/ml) | 36.3 |
| 12. | Vincristine Sulfate (1 mg/ml) | >240 |
Please note the following drugs, Carmustine and Thiotepa, have extremely low permeation times of 9.1 and 36.3 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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§ 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.