(113 days)
This Surgeons glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves are tested for use with Chemotherapy Drugs. Testing based on ASTM D6978-05
Surgeons glove is a device made of synthetic rubber
This document, a 510(k) premarket notification for surgical gloves, does not contain information about the acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device. Instead, it details the substantial equivalence determination for NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs.
The information provided describes the performance of the surgical gloves against chemotherapy drugs, which can be interpreted as a form of acceptance criteria for their intended use. However, this is for a physical medical device, not an AI/ML software device.
Here's an analysis of the provided information, framed as if it were acceptance criteria and performance data for the surgical gloves, but it explicitly does not fulfill the input request for an AI/ML study:
-
Table of Acceptance Criteria and Reported Device Performance
DRUG Acceptance Criteria (Minimum Breakthrough Detection Time) Reported Device Performance (Breakthrough Detection Time - Specimen 1/2/3) Carmustine (BCNU), 3.3 mg/ml (3,300ppm) Not explicitly stated as an acceptance criterion, but the performance is presented. 30.6 minutes (30.6, 30.6, 30.8) Cisplatin, 1.0 mg/ml (1,000ppm) Not explicitly stated as an acceptance criterion. Up to 240 minutes Cyclophosphamide (Cytoxan), 20 mg/ml (20,000ppm) Not explicitly stated as an acceptance criterion. Up to 240 minutes Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) Not explicitly stated as an acceptance criterion. Up to 240 minutes Doxorubicin Hydrochloride, 2.0 mg/ml (2,000ppm) Not explicitly stated as an acceptance criterion. Up to 240 minutes Etoposide (Toposar), 20.0 mg/ml (20,000ppm) Not explicitly stated as an acceptance criterion. Up to 240 minutes Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) Not explicitly stated as an acceptance criterion. Up to 240 minutes Fluorouracil, 50.0 mg/ml (50,000ppm) Not explicitly stated as an acceptance criterion. Up to 240 minutes Thiotepa, 10.0 mg/ml (10,000ppm) Not explicitly stated as an acceptance criterion. 31.2 minutes (31.2, 60.8, 61.3) Vincristine Sulfate, 1.0 mg/ml (1,000ppm) Not explicitly stated as an acceptance criterion. Up to 240 minutes Note: The document presents the "Minimum Breakthrough Detection Time" as the reported performance, implying that the acceptance criterion would be a minimum threshold for this time for each drug. The phrasing "Up to 240" for most drugs suggests that the glove maintained integrity for the full 240-minute test duration without breakthrough. The note about "low permeation times" for Carmustine and Thiotepa indicates that their breakthrough times (30.6 and 31.2 minutes, respectively) are considerably shorter than the other tested drugs.
-
Sample size used for the test set and the data provenance:
- Sample Size: For each drug, 3 specimens were tested to determine the breakthrough detection time.
- Data Provenance: Not specified, but the testing is "based on ASTM D6978-05," a standard test method for resistance of medical gloves to permeation by chemotherapy drugs. The device manufacturer is Terang Nusa, Sdn. Bhd. in Malaysia, suggesting the testing likely occurred in a similar region or a certified lab. The study is prospective in the sense that the testing was performed specifically to characterize the device's performance.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this document. The "ground truth" here is the physical measurement of drug breakthrough, determined by standardized laboratory methods (ASTM D6978-05), not by human expert interpretation of images or clinical data.
-
Adjudication method for the test set:
- Not applicable. The result is a measured value (time in minutes) from a standardized test, not a subjective assessment requiring adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable. This is not an AI/ML diagnostic or assistive device that would involve human readers.
-
If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device (surgical gloves), not an algorithm.
-
The type of ground truth used:
- Physical Measurement: The ground truth is the experimentally determined "Minimum Breakthrough Detection Time" of various chemotherapy drugs through the glove material, established according to the ASTM D6978-05 standard. This is an objective, quantitative measurement.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The gloves are manufactured and then tested to characterize their properties.
-
How the ground truth for the training set was established:
- Not applicable. There is no training set for this device.
§ 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).