(150 days)
This surgeon's glove is a disposable device made of synthetic polychloroprene intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. These gloves are tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
This surgeon's glove is a disposable device made of synthetic polychloroprene.
The provided text describes the regulatory clearance for a surgical glove and its testing against chemotherapy drugs. It does not describe an AI medical device or a study involving human or AI readers. Therefore, I cannot fulfill the request for information on acceptance criteria and study details related to an AI device.
The document is a 510(k) clearance letter for a medical device: "SensiCare® Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)". The "acceptance criteria" and "device performance" in this context refer to the glove's resistance to permeation by chemotherapy drugs, as outlined in ASTM D6978-05.
Here's the relevant information extracted from the provided text, formatted to match parts of your request where applicable, noting that much of your requested AI-specific information is not present:
1. Table of acceptance criteria and the reported device performance
| Chemotherapy Drug | Concentration | Acceptance Criteria (Permeation Breakthrough Detection Time) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|---|---|
| Bleomycin | 15 mg/ml | >240 minutes | >240 minutes |
| Busulfan | 6 mg/ml | >240 minutes | >240 minutes |
| Carboplatin | 10.0 mg/ml | >240 minutes | >240 minutes |
| Carmustine (BCNU) | 3.3 mg/ml | A minimum acceptable breakthrough time (not explicitly stated, but implied by the reported value) | 36.3 (36.3, 37.4, 38.4) minutes |
| Cisplatin | 1.0 mg/ml | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20 mg/ml | >240 minutes | >240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 minutes | >240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 minutes | >240 minutes |
| Epirubicin (Ellence) | 2 mg/ml | >240 minutes | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | >240 minutes | >240 minutes |
| Fludarabine | 25.0 mg/ml | >240 minutes | >240 minutes |
| Fluorouracil | 50.0 mg/ml | >240 minutes | >240 minutes |
| Idarubicin | 1.0 mg/ml | >240 minutes | >240 minutes |
| Ifosfamide | 50.0 mg/ml | >240 minutes | >240 minutes |
| Mechlorethamine HCl | 1.0 mg/ml | >240 minutes | >240 minutes |
| Melphalan | 5 mg/ml | >240 minutes | >240 minutes |
| Methotrexate | 25 mg/ml | >240 minutes | >240 minutes |
| Mitomycin C | 0.5 mg/ml | >240 minutes | >240 minutes |
| Mitoxantrone | 2.0 mg/ml | >240 minutes | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 minutes | >240 minutes |
| Paraplatin | 10 mg/ml | >240 minutes | >240 minutes |
| Rituximab | 10 mg/ml | >240 minutes | >240 minutes |
| Thiotepa | 10.0 mg/ml | A minimum acceptable breakthrough time (not explicitly stated, but implied by the reported value) | 49.2 (56.0, 49.2, 78.5) minutes |
| Vincristine Sulfate | 1.0 mg/ml | >240 minutes | >240 minutes |
CAUTION: The document specifically highlights: "Testing showed a minimum breakthrough time of 36.3 minutes with Carmustine and 49.2 minutes for Thiotepa." This suggests these values met an implicit acceptance criterion for these specific drugs, as they did not achieve the ">240 minutes" seen with most other drugs.
Regarding the AI-specific questions (2-9), the provided text does not contain any information as it pertains to a physical medical device (surgical gloves) and not an AI/software device:
- 2. Sample size used for the test set and the data provenance: Not applicable. The testing is for physical properties of a glove, following 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 is established by laboratory testing procedures as per ASTM D6978-05.
- 4. Adjudication method 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. This device is not an AI algorithm for reading medical cases.
- 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: For this device, the "ground truth" would be the experimentally determined breakthrough times by a recognized standard (ASTM D6978-05).
- 8. The sample size for the training set: Not applicable. This is not a machine learning model.
- 9. How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 28, 2020
Medline Industries, Inc. Matt Clausen Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K192820
Trade/Device Name: SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: January 13, 2020 Received: January 15, 2020
Dear Matt Clausen:
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.
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
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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 medical devices and radiation-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 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
SensiCare® Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
This surgeon's glove is a disposable device made of synthetic polychloroprene intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. These gloves are tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemicals have been tested with these gloves.
Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.
Bleomycin 15 mg/ml >240 minutes Busulfan 6 mg/ml >240 minutes Carboplatin 10.0 mg/ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 36.3 (36.3, 37.4, 38.4) minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20 mg/ml >240 minutes Dacarbazine (DTIC) 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Epirubicin (Ellence) 2 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Idarubicin 1.0 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5 mg/ml >240 minutes Methotrexate 25 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10 mg/ml >240 minutes Rituximab 10 mg/ml >240 minutes Thiotepa 10.0 mg/ml 49.2 (56.0. 49.2, 78.5) minutes Vincristine Sulfate 1.0 mg/ml >240 minutes
CAUTION: Testing showed a minimum breakthrough time of 36.3 minutes with Carmustine and 49.2 minutes for Thiotepa.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).