(225 days)
These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.
This document is a 510(k) premarket notification for a medical device: "Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential" (K230079). It compares the new device to a predicate device (K190018) and provides evidence of performance through various tests.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison of the subject device (K230079) against a predicate device (K190018) and also summarizes non-clinical testing. Below is a compilation of the acceptance criteria (standards/guidance/test criteria) and the reported device performance.
| Test/Characteristic | Acceptance Criteria (Standard/Guidance/Criteria) | Reported Device Performance (K230079) |
|---|---|---|
| Chemotherapy Permeation | ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | All drugs with BDT >240 minutes met criteria. |
| Carmustine (BCNU) (3.3 mg/ml): 12.6 minutes | ||
| Thiotepa (10.0 mg/ml): 26.6 minutes | ||
| (Note: For marketing, the device labels a warning against using with Carmustine and Thiotepa due to "extremely low permeation times".) | ||
| Dimensions (Length) | ASTM D3577 requirements: Minimum 265mm | Pass |
| Dimensions (Palm Width) | ASTM D3577 requirements (specific to each size 5.5-9.0, e.g., 5.5: 70±6mm, 9.0: 114±6mm) | Pass for all sizes |
| Dimensions (Thickness - Finger) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Dimensions (Thickness - Palm) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Dimensions (Thickness - Cuff) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Physical Properties | ASTM D3577-19 requirements for tensile strength, ultimate elongation, and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves | Pass |
| Freedom from holes | ASTM D3577-19 and ASTM D5151-06 requirements; AQL 1.5 | Pass |
| Powder-Free | ASTM D3577-19, ASTM D6124-06 requirements: ≤ 2 mg per glove | Pass |
| Sterility | ANSI/AAMI/ISO 11137-1:2018 requirement of 10^-6 SAL | Pass |
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009: Non-cytotoxic (as the general acceptance criteria) | Under the conditions of the study, the device was found to be cytotoxic. However, "the device extracts did not elicit acute systemic response in the animal model" in the follow-up Acute Systemic Toxicity test (ISO 10993-11). This is a notable finding, indicating the device failed the initial cytotoxicity but was deemed safe due to subsequent testing. |
| ISO Skin Irritation Study | ISO 10993-10:2010: Not an irritant | Pass |
| ISO Maximization Sensitization Study | ISO 10993-10:2010: Not a sensitizer | Pass |
| ISO Acute Systemic Toxicity Study | ISO 10993-11:2006: No mortality or evidence of acute systemic toxicity | Pass (addressed after initial cytotoxicity finding) |
| Human Skin Sensitization | Modified Draize-95 Test (per FDA guidance): Not a sensitizer (demonstrates low dermatitis potential) | Pass: "The results showed low dermatitis potential for the human subject tested." |
| Endotoxin Study | Less than 20.0 EU/device | Pass: "test results indicate low endotoxin level" |
| Material Mediated Pyrogenicity Study | ISO 10993-11:2017: Meets the material mediated pyrogenicity requirement | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Chemotherapy Drug Permeation (ASTM D6978-05): The document specifies the standard used but does not provide the exact sample size for the test sets (number of gloves or replicates per drug). The data is generated from laboratory testing ("under the conditions of the study"). Data provenance is not explicitly stated but implies laboratory testing for regulatory submission.
- Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Sterility: These tests refer to ASTM and ISO standards (e.g., ASTM D3577, ASTM D5151, ASTM D6124, ISO 11137-1). These standards typically define the sampling plans (e.g., AQL 1.5 for freedom from holes), but the specific number of units tested for this submission is not directly stated. Data provenance implies manufacturer's testing for regulatory submission.
- Biocompatibility (ISO 10993 series): These are biological evaluations. The document refers to "the conditions of the study" and "animal model" for acute systemic toxicity but does not provide specific sample sizes (e.g., number of animals used). Data provenance implies laboratory testing for regulatory submission.
- Human Skin Sensitization (Modified Draize-95 Test): This test was performed on "human subject tested." The sample size (number of human subjects) is not explicitly given, it ambiguously states "the human subject tested." Data provenance is from a clinical test as per FDA guidance.
- Endotoxin Study & Material Mediated Pyrogenicity Study: The document refers to "the conditions of the study" but does not provide sample sizes. Data provenance implies laboratory testing for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This submission is for a physical device (surgical gloves) and its material properties, not an AI/algorithm-driven device requiring expert image interpretation or similar ground truth establishment. Therefore, the concept of "experts" establishing a ground truth in that context is not applicable here. The "ground truth" for the performance tests (e.g., breakthrough time, tensile strength) is established by the validated methodologies of the referenced ASTM and ISO standards.
4. Adjudication Method for the Test Set:
Not applicable in the context of material and physical property testing of a device like surgical gloves. Test results are objective measurements based on defined standard protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This is not an AI device or a diagnostic imaging device where human reader performance is evaluated.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Not applicable as this is not an AI/algorithm device. The performance tests evaluate the physical gloves without any "human-in-the-loop" interaction in the testing methodology itself beyond conducting the tests.
7. The Type of Ground Truth Used:
- Objective Measurement Standards: For most physical and chemical properties (dimensions, strength, freedom from holes, powder, sterility, chemotherapy permeation, endotoxin, pyrogenicity), the "ground truth" is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards. The results are quantitative measurements against these predefined thresholds.
- Biological Response in Models: For biocompatibility tests (cytotoxicity, skin irritation, sensitization, acute systemic toxicity), the "ground truth" is established by observing biological responses in in vitro or in vivo (animal) models as per ISO 10993 standards and the Modified Draize-95 Test for human skin sensitization.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured physical product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of 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).