(159 days)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 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) 38.5 minutes (57.2, 57.3, 38.5) 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) 38.6 minutes (39.0, 39.3, 38.6) Vincristine Sulfate (1.0 mg/ml) >240 minutes
Caution: Testing showed a minimum breakthrough time of 38.5 minutes for Carmustine and 38.6 minutes for Thiotepa.
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Based on the provided document, which is an FDA 510(k) clearance letter for a surgical glove, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" related to an AI/ML medical device is not applicable.
The document describes the clearance of a physical medical device: "Dermasure Green Sterile Synthetic Polychloroprene Powder-Free Surgical Glove (Tested for Use with Chemotherapy Drugs)".
Therefore, information regarding AI/ML device performance metrics, training sets, test sets, ground truth establishment, expert adjudication, or MRMC studies for AI/ML algorithms will not be present in this document.
The "study" referenced in the document is the testing performed on the gloves for permeation by chemotherapy drugs according to ASTM D6978.
Here's how the provided information relates to the "device meets acceptance criteria" for this specific product:
1. A table of acceptance criteria and the reported device performance:
| Chemotherapy Drug | Acceptance Criterion (Breakthrough Detection Time) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|---|
| Bleomycin (15 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Busulfan (6 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Carboplatin (10.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Carmustine (BCNU) (3.3 mg/ml) | Not explicitly stated as a minimum, but implies >38.5 min | 38.5 minutes (observed triplicate 57.2, 57.3, 38.5) |
| Cisplatin (1.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Dacarbazine (DTIC) (10.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Epirubicin (Ellence) (2 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Etoposide (Toposar) (20.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Fludarabine (25.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Idarubicin (1.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Ifosfamide (50.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Mechlorethamine HCI (1.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Melphalan (5 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Methotrexate (25 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Mitoxantrone (2.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Paclitaxel (Taxol) (6.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Paraplatin (10 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Rituximab (10 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
| Thiotepa (10.0 mg/ml) | Not explicitly stated as a minimum, but implies >38.6 min | 38.6 minutes (observed triplicate 39.0, 39.3, 38.6) |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated as a minimum, but implies >240 min desired | >240 minutes |
Note: The document implies an acceptance criterion of either maintaining protection for at least 240 minutes or demonstrating the actual breakthrough time, particularly noting the lower times for Carmustine and Thiotepa.
The remaining points (2-9) are not relevant to this document as it pertains to a physical glove, not an AI/ML algorithm.
This document specifically states: "these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard dictates the methodology for testing the physical barrier properties of the gloves, not the performance of an AI/ML algorithm.
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April 1, 2020
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60030
Re: K192988
Trade/Device Name: Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC Dated: February 26, 2020 Received: February 27, 2020
Dear Jennifer Mason:
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
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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 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,
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192988
Device Name
Dermassure Green Sterile Synthetic Polychloroprene Powder-Free Surgical Glove (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 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) 38.5 minutes (57.2, 57.3, 38.5) 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) 38.6 minutes (39.0, 39.3, 38.6) Vincristine Sulfate (1.0 mg/ml) >240 minutes
Caution: Testing showed a minimum breakthrough time of 38.5 minutes for Carmustine and 38.6 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).