(100 days)
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject device is single use, disposable gloves intended for medical purposes to be worn on the examiner's hands to prevent contamination between patient and examiner. The gloves are powder-free, ambidextrous with beaded cuff, blue colored, nitrile, and tested for use with chemotherapy drugs and Fentanyl Citrate. The gloves are offered in five sizes: XS, S, M, L, XL. The subject device is non-sterile.
This document is a 510(k) Premarket Notification for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate." It seeks to demonstrate substantial equivalence to a legally marketed predicate device.
The study described here is NOT for an AI/ML device, but rather for a physical medical device (examination gloves). Therefore, many of the requested items (e.g., number of experts, adjudication method, MRMC study, standalone algorithm performance, AI system effect size, sample size for training set, ground truth for training set) are not applicable to this type of device and are not present in the provided text.
However, I can extract information related to the acceptance criteria and how the physical glove device meets those criteria.
Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and device performance are primarily based on established ASTM and ISO standards for examination gloves, particularly concerning physical properties, integrity, and resistance to permeation by chemotherapy drugs.
| Test Method / Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D6319 (Physical Dimensions) | Length: | Length: |
| XS/S: ≥220 mm | XS/S: ≥220 mm (Pass) | |
| M/L/XL: ≥230 mm | M/L/XL: ≥230 mm (Pass) | |
| Width: | Width: | |
| XS: 70±10 mm | XS: 78-80 mm (Pass) | |
| S: 80±10 mm | S: 83-86 mm (Pass) | |
| M: 95±10 mm | M: 93-96 mm (Pass) | |
| L: 110±10 mm | L: 103-106 mm (Pass) | |
| XL: 120±10 mm | XL: 113-116 mm (Pass) | |
| Thickness: | Thickness: | |
| Finger: ≥0.05 mm | Finger: 0.07-0.10 mm (Pass) | |
| Palm: ≥0.05 mm | Palm: 0.06-0.07 mm (Pass) | |
| ASTM D5151 (Watertightness for Detection of Holes) | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 / Pass (This likely means 0 failures out of 125 samples tested, meeting the AQL of 2.5) |
| ASTM D6124 (Powder Content) | Meet the requirements of ASTM D6124 240 Minutes | |
| Cyclophosphamide (20.0 mg/ml): >240 Minutes | ||
| Dacarbazine (10.0 mg/ml): >240 Minutes | ||
| Doxorubicin HCI (2.0 mg/ml): >240 Minutes | ||
| Etoposide (20.0 mg/ml): >240 Minutes | ||
| Fluorouracil (50.0 mg/ml): >240 Minutes | ||
| Methotrexate (25.0 mg/ml): >240 Minutes | ||
| Mitomycin C (0.5 mg/ml): >240 Minutes | ||
| Paclitaxel (6.0 mg/ml): >240 Minutes | ||
| ThioTepa (10.0 mg/ml): 11.0 Minutes (Note: lower than predicate's) | ||
| Vincristine Sulfate (1.0 mg/ml): >240 Minutes | ||
| Fentanyl Citrate Injection (100.0 mcg/2ml): >240 Minutes |
Study Information (as applicable to a physical medical device)
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Sample Size Used for the Test Set and Data Provenance:
- Watertightness Test (Holes): 125 samples (0/125 / Pass).
- Physical Dimensions, Powder Content, Physical Properties (Tensile Strength, Elongation): Specific sample sizes for these tests are not explicitly stated, but are implied by the standard test methods (e.g., ASTM D6319, ASTM D6124, ASTM D412). Generally, these are conducted on a statistically significant number of samples per batch/lot to ensure quality.
- Biocompatibility Testing: The number of samples/animals used in ISO 10993 tests is not specified in this summary but would be detailed in the full test reports.
- Chemotherapy Permeation Testing: The number of samples tested per drug (as per ASTM D6978-05) is not specified in this summary.
- Data Provenance: The manufacturing entity is RMKH Glove (Cambodia) Co., Ltd. (Cambodia). The testing was conducted "in accordance with" various international standards (ASTM, ISO). The specific laboratories conducting the tests are not named, nor is it explicitly stated if the data is retrospective or prospective, though for
510(k) submissions, bench testing is typically performed prospectively for the submission.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable as the "ground truth" for this device is based on objective, quantifiable physical and chemical properties measured according to established international standards (ASTM, ISO), rather than expert interpretation of a diagnostic output.
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Adjudication Method for the Test Set:
- Not applicable for objective physical and chemical bench testing. Test results are pass/fail based on pre-defined criteria from recognized standards.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device (examination glove), not an AI-powered diagnostic device.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (examination glove), not an AI-powered diagnostic device.
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The Type of Ground Truth Used:
- Objective Measurement Data: The "ground truth" (or more appropriately, the performance benchmark) is established through adherence to recognized international standards and specifications for glove manufacturing and performance. This includes:
- Physical dimensions
- Mechanical properties (tensile strength, elongation)
- Integrity (freedom from holes)
- Chemical properties (powder content)
- Biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity)
- Permeation resistance to specific chemicals (chemotherapy drugs, fentanyl citrate).
- These are quantifiable measurements against pre-defined thresholds outlined in standards like ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993 series, and ASTM D6978.
- Objective Measurement Data: The "ground truth" (or more appropriately, the performance benchmark) is established through adherence to recognized international standards and specifications for glove manufacturing and performance. This includes:
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The Sample Size for the Training Set:
- Not applicable. This is a physical medical device; there is no "training set" in the context of an AI/ML algorithm. The manufacturing process and formulation are developed to meet these standards.
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How the Ground Truth for the Training Set was Established:
- Not applicable. There is no "training set" or "ground truth for the training set" in the context of AI/ML algorithms for this device. The product development process aims to manufacture a device that consistently meets the performance specifications defined by the relevant ASTM and ISO standards.
Note on Biocompatibility (Cytotoxicity): The report states "Under conditions of the study, device extract is cytotoxic." However, the overall conclusion is that the device "passed" biocompatibility tests. This apparent contradiction is common in 510(k) summaries where initial in-vitro tests might show some cytotoxic effect, but subsequent analysis (e.g., considering dose, route of exposure, or the results of in-vivo tests like irritation or systemic toxicity) determines that the observed cytotoxicity is not clinically significant or that the device is still considered safe for its intended use. Without the full biocompatibility report, the exact rationale for this "pass" despite measurable cytotoxicity cannot be fully detailed.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.