(209 days)
A 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. These gloves were tested for use with chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only.
Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs
This document describes the acceptance criteria and the study results for the "Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs".
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for gloves used with chemotherapy drugs are typically based on the "breakthrough detection time" of various chemotherapy drugs as per ASTM D6978-05. While the document doesn't explicitly state a minimum acceptance time for all drugs (other than the general implication that a longer breakthrough time is better), the reported performance indicates that breakthrough times greater than 240 minutes are considered acceptable for most. However, two drugs showed significantly shorter breakthrough times, which the manufacturer highlights with a warning.
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes (Acceptance Criteria Implicitly >240 min for safe use) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| 1. Carmustine (BCNU), 3.3mg/ml | Not explicitly defined, but <240 min is a warning | 27.1 |
| 2. Cisplatin, 1.0mg/ml | >240 | >240 |
| 3. Cyclophosphamide (Cytoxan), 20mg/ml | >240 | >240 |
| 4. Dacarbazine (DTIC) 10mg/ml | >240 | >240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | >240 | >240 |
| 6. Etoposide (Toposar), 20mg/ml | >240 | >240 |
| 7. Fluorouracil 50mg/ml | >240 | >240 |
| 8. Paclitaxel (Taxol), 6.0mg/ml | >240 | >240 |
| 9. Thiotepa, 10mg/ml | Not explicitly defined, but <240 min is a warning | 27.4 |
Note: The document explicitly states: "Please note that Carmustine (BCNU) has low permeation time of 27.1 minutes and Thiotepa has permeation time of 27.4 minutes. WARNING: Do not use with Carmustine and Thiotepa." This indicates that for Carmustine and Thiotepa, the device does not meet the implied acceptance criteria for safe use with chemotherapy drugs, leading to the warning.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for testing, nor does it provide information on the country of origin of the data or whether the study was retrospective or prospective. It only states that the gloves "were tested for use with chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." ASTM D6978 specifies the method for testing, and the number of replicates would be determined by its guidelines, but this specific information is not in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a study on the physical properties of a medical device (gloves' permeation resistance to chemotherapy drugs), not a diagnostic device relying on expert interpretation. Therefore, there were no human experts establishing ground truth in the way a medical image interpretation study would. The ground truth is objective measurement data derived from laboratory testing according to a standardized method (ASTM D6978-05).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this is laboratory testing of physical properties, not a study involving human interpretation or adjudication.
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 not a study involving AI or human readers. It's a test of the physical properties (permeation resistance) of a medical glove.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used is objective quantitative measurements of breakthrough detection time for specific chemotherapy drugs, performed according to the standardized laboratory method ASTM D6978-05.
8. The sample size for the training set
Not applicable. This is not a machine learning/AI device, and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable. No training set exists for this type of device testing.
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July 8, 2018
Shen Wei USA Inc. Cheryl Reep Compliance Director 33278 Central Ave Ste 102 Union City, California 94587
Re: K173766
Trade/Device Name: PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: June 19, 2018 Received: July 3, 2018
Dear Cheryl Reep:
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. 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
510(k) Number (if known)
K173766
Device Name
Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
A 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. These gloves were tested for use with chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only.
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes |
|---|---|
| 1. Carmustine (BCNU), 3.3mg/ml | 27.1 |
| 2. Cisplatin, 1.0mg/ml | >240 |
| 3. Cyclophosphamide (Cytoxan), 20mg/ml | >240 |
| 4. Dacarbazine (DTIC) 10mg/ml | >240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| 6. Etoposide (Toposar), 20mg/ml | >240 |
| 7. Fluorouracil 50mg/ml | >240 |
| 8. Paclitaxel (Taxol), 6.0mg/ml | >240 |
| 9. Thiotepa, 10mg/ml | 27.4 |
*Please note that Carmustine (BCNU) has low permeation time of 27.1 minutes and Thiotepa has permeation time of 27.4 minutes.
WARNING: Do not use with Carmustine and Thiotepa.
| 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)
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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.