(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.
§ 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).