(459 days)
A Powder Free White Sterilized Polyisoprene Surgical Gloves- Tested for Use with Chemotherapy Drugs is a disposable device intended for invasive surgery procedures that is to be worn on both the hands by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drug as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs.
This document is a 510(k) clearance letter for Powder Free White Sterilized Polyisoprene Surgical Gloves. It is for a medical device and not for an AI/ML powered device, therefore no AI-specific performance criteria or studies are present.
Here's an analysis based on the provided text, focusing on the available information regarding device performance and acceptance criteria, even though it's not an AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for these surgical gloves relate to their resistance to permeation by chemotherapy drugs, as tested according to ASTM D 6978. The "acceptance criteria" here implicitly refers to showing sufficient resistance, often exceeding a certain time threshold, though the direct numerical acceptance threshold isn't explicitly stated but inferred from the predicate device comparisons and the nature of such testing. For chemotherapy gloves, a breakthrough time of >240 minutes is generally considered ideal for many drugs.
| Chemotherapy Drug Permeation and Concentration | Acceptance Criteria (Implicit) | Reported Device Performance (Average Breakthrough Detection Time) |
|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | (Likely >240 min for ideal) | 12.6 min |
| Cisplatin 1.0 mg/ml (1,000ppm) | (Likely >240 min for ideal) | >240 min |
| Cyclophosphamide (Cytoxan) 20mg/ml (20,000ppm) | (Likely >240 min for ideal) | >240 min |
| Dacarbazine (DTIC) 10.0 mg/ml (10,000ppm) | (Likely >240 min for ideal) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | (Likely >240 min for ideal) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | (Likely >240 min for ideal) | >240 min |
| Fluorouracil 50.0 mg/ml (50,000ppm) | (Likely >240 min for ideal) | >240 min |
| Ifosfamide 50.0 mg/ml (50,000ppm) | (Likely >240 min for ideal) | >240 min |
| Methotrexate 25 mg/ml (25,000ppm) | (Likely >240 min for ideal) | >240 min |
| Mitomycin C 0.5 mg/ml (500ppm) | (Likely >240 min for ideal) | >240 min |
| Mitoxantrone 2.0 mg/ml (2,000ppm) | (Likely >240 min for ideal) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | (Likely >240 min for ideal) | >240 min |
| Thio-Tepa 10.0 mg/ml (10,000ppm) | (Likely >240 min for ideal) | 12.0 min |
| Vincristine Sulfate 1.0 mg/ml (1,000ppm) | (Likely >240 min for ideal) | >240 min |
Note: The document explicitly states: "Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes." This suggests that while ideal is >240 min, the device still meets FDA requirements given its overall performance and comparison to predicate devices, and likely appropriate labeling for users about these specific drugs.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the permeation testing (i.e., how many gloves were tested for each drug). The data provenance refers to "as per ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug," indicating a standardized laboratory test method. It is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the human data sense.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. This is a physical device subject to standardized chemical permeation testing, not a diagnostic device requiring expert opinion for ground truth. The "ground truth" is established by the chemical permeation laboratory measurement according to the ASTM D 6978 standard.
4. Adjudication Method for the Test Set
Not applicable, as the "ground truth" is based on objective chemical permeation measurements rather than subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML-powered diagnostic or interpretive device.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth used is objective laboratory measurement of chemotherapy drug permeation, specifically the "Average Breakthrough Detection Time" determined according to ASTM D 6978 - Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drug.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical 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).