(83 days)
The Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between the patient and examiner.
The gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
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The provided FDA document (K202179) is a 510(k) premarket notification for Medline Glide-On 3G Vinyl Examination Gloves, which were tested for use with chemotherapy drugs. This document focuses on the substantial equivalence determination for a medical device (gloves) and their material properties, specifically their resistance to chemotherapy drug permeation.
The information requested in your prompt (acceptance criteria and study details for an AI/device performance evaluation) is not applicable to this type of FDA submission. This is not a submission for an AI-powered diagnostic device, but rather for a physical medical glove. Therefore, there is no AI algorithm, no test set for an algorithm, no ground truth established by experts, no MRMC study, and no training set involved in this document.
However, I can extract the closest equivalent information from the document regarding the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of these gloves:
Acceptance Criteria and Device Performance (Closest Equivalent for a Physical Device)
The "acceptance criteria" here relate to the ability of the gloves to resist permeation by various chemotherapy drugs, as defined by the ASTM D6978-05 standard. The "reported device performance" is the actual time it took for the drugs to break through the glove material.
| Chemotherapy Drug | Acceptance Criteria (Implicit from Industry Standard/Expected Performance) | Reported Device Performance (Minimum Breakthrough Detection) | Comment |
|---|---|---|---|
| Carmustine | High resistance (longer breakthrough time) is desirable. | 11.4 minutes | WARNING: DO NOT USE WITH CARMUSTINE (Indicates this performance did not meet safe use criteria) |
| Cisplatin | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Cyclophosphamide | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Dacarbazine | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Doxorubicin HCl | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Etoposide | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Fluorouracil | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Methotrexate | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Paclitaxel | High resistance (longer breakthrough time) is desirable. | >240 minutes | Exceeds 4 hours, indicating good resistance for this drug. |
| Thiotepa | High resistance (longer breakthrough time) is desirable. | 17.4 minutes | WARNING: DO NOT USE WITH THIOTEPA (Indicates this performance did not meet safe use criteria) |
Regarding the other points in your prompt:
- 2. Sample size used for the test set and the data provenance: The document does not specify the sample size (number of gloves tested) or the exact provenance of the test data (e.g., country of origin, retrospective/prospective). The testing method specified is ASTM D6978-05.
- 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 glove permeation is established by laboratory measurement using a standardized test method (ASTM D6978-05), not by human expert consensus or radiologists.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The "ground truth" is a direct measurement based on a physical test.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable. This is for evaluating diagnostic performance with human readers, which is not relevant for a physical glove.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for glove permeation is based on the direct results from the ASTM D6978-05 standard test method for assessing permeation by chemotherapy drugs. This involves a specific experimental setup to detect the breakthrough time of a chemical.
- 8. The sample size for the training set: Not applicable. This product does not involve machine learning or a training set.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document details the testing of physical gloves against chemical permeation standards, not the performance of an AI or diagnostic algorithm.
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October 26, 2020
Medline Industries, Inc. Adam Ostrower Regulatory Affairs Sr. Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K202179
Trade/Device Name: Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, OPJ Dated: August 3. 2020 Received: August 4, 2020
Dear Adam Ostrower:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs)
Indications for Use (Describe)
The Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) are a disposable device intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between the patient and examiner.
The gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy | Drug Concentration | Minimum Breakthrough Detection |
|---|---|---|
| Carmustine | 3.3 mg/ml | 11.4 minutes |
| Cisplatin | 1.0 mg/ml | >240 minutes |
| Cyclophosphamide | 20.0 mg/ml | >240 minutes |
| Dacarbazine | 10.0 mg/ml | >240 minutes |
| Doxorubicin Hydrocholoride | 2.0 mg/ml | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | >240 minutes |
| Fluorouracil | 50.0 mg/ml | >240 minutes |
| Methotrexate | 25.0 mg/ml | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 minutes |
| Thiotepa | 10.0 mg/ml | 17.4 minutes |
WARNING: DO NOT USE WITH CARMUSTINE DO NOT USE WITH 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.