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Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs) is a non-sterile, single-use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The subject device, Non-sterile Powder Free Nitrile Examination Gloves (tested for use with Chemotherapy Drugs), is a single use, disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene with a blue color additive. The gloves are provided in sizes XS, S. M, L and XL.

The provided text describes the acceptance criteria and performance of "Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)" in comparison to a predicate device. This is a medical device submission, and the information is presented as part of a 510(k) summary to the FDA. As such, the "study" referred to is a series of non-clinical tests performed to demonstrate substantial equivalence, rather than a clinical study involving human patients.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents the acceptance criteria and results mainly in reference to established ASTM and ISO standards for medical gloves. The "Reported Device Performance" column directly reflects the results from the non-clinical tests.

• Width: 70mm (±10mm) - XS, 80mm (±10mm) - S, 95mm (±10mm) - M, 110mm (±10mm) - L, 120mm (±10mm) - XL
• Overall Length: 220 mm (Minimum) – S and XS, 230 mm (Minimum) – M, L and XL
• Thickness: Finger - 0.05 mm (Minimum), Palm - 0.05mm (Minimum) | Pass (met listed dimension requirements) |
  | ASTM D412-16 | Standards test method for Vulcanized Rubber and Thermoplastics Elastomer - Tension | Physical properties:
• Before Aging:
  • Tensile strength: min 14MPa
  • Elongation: min 500%
• After Aging:
  • Tensile strength: min 14MPa
  • Elongation: min 400% | Pass (met listed physical property requirements) |
    | ASTM D5151-19 | Standard Test Method for detection of Holes in Medical Gloves | Pass Inspection Level G1, AQL 2.5 | Pass |
    | ASTM D6124-06 | Standard Test Method for Residual Powder on Medical Gloves | Residual powder meets specification 240 minutes
    Cyclophosphamide (Cytoxan®): > 240 minutes
    Dacarbazine (DTIC): > 240 minutes
    Doxorubicin Hydrochloride: > 240 minutes
    Etoposide (Toposar®): > 240 minutes
    Fluorouracil: > 240 minutes
    Paclitaxel (Taxol®): > 240 minutes
    Thiotepa: 15.0 minutes
    Warning: Do not use with Carmustine and Thiotepa due to low permeation times. |
    | ISO 10993-5 | Biological Evaluation on Medical Devices - Part 5: Test for In Vitro Cytotoxicity | Pass in vitro cytotoxicity | Exhibited "Severe" reactivity at 100% concentration and no cytotoxic effect at 10% concentration. (Note: A systemic toxicity study was performed to address the safety of materials given the cytotoxicity result). |
    | ISO 10993-10 | Biological evaluation on medical device Part 10: Test for Irritation and Skin Sensitization | No irritating and sensitizing | Under the condition of study not an irritant or a sensitizer. |
    | ISO 10993-11 | Biological Evaluation of Medical Devices - Part 11: Test for Systemic Toxicity | No systemic toxic | Under the condition of the test, not a systemic toxicity. |

2. Sample Sizes Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not explicitly state a consolidated sample size for all tests. However, for specific tests, it does provide some details:
  • Freedom from Holes (ASTM D5151-19): AQL = 2.5, Inspection level G1. This standard outlines sampling plans, but the exact number of units tested is not provided in this summary. The predicate device mention "125 samples from batch of 35000", which gives a hint on the sample size used, but this is for the predicate not the subject device.
  • The other non-clinical tests (e.g., physical properties, biocompatibility, chemotherapy permeation) would also have specific sample sizes as per their respective standards, but these are not enumerated in this summary.
• Data Provenance: The document does not explicitly state the country-of-origin for the "data" or whether the tests were retrospective or prospective. Given that this is a 510(k) summary for a device manufactured by "RUBBEREX ALLIANCE SDN BHD" in Malaysia, it is highly probable that the testing was performed in conjunction with the manufacturer or by contract labs. The tests are prospective as they are conducted specifically for the device submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This section is not applicable as the described "study" consists of non-clinical, laboratory-based tests of physical properties and chemical resistance of gloves against established standards (ASTM, ISO). There is no "ground truth" derived from expert interpretation of medical images or patient outcomes data in this context. The "ground truth" is adherence to the objective criteria defined by the test methods and standards.

4. Adjudication Method for the Test Set:

This section is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or studies involving subjective human interpretation (e.g., reviewing medical images) to resolve discrepancies. The tests described here are objective laboratory measurements against defined standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This section is not applicable. An MRMC study assesses the effectiveness of a diagnostic device or AI with and without human readers. The device in question is a medical glove, for which such a study design is irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This section is not applicable. "Standalone" performance usually refers to the performance of an AI algorithm without human interaction. This document describes the performance of a physical medical device (gloves) through laboratory tests, not an AI algorithm. The performance described is "standalone" in the sense that it's the intrinsic performance of the glove material.

7. Type of Ground Truth Used:

The "ground truth" for the performance of these gloves is based on:

• Established Standard Specifications: e.g., ASTM D6319-19 for dimensions, tensile strength, elongation.
• Standardized Test Methods and Protocols: e.g., ASTM D5151-19 for holes, ASTM D6124-06 for residual powder, ASTM D6978-05 for chemotherapy drug permeation, ISO 10993 series for biocompatibility.
• The results are quantitative measurements interpreted against pre-defined thresholds or criteria derived from these standards.

8. Sample Size for the Training Set:

This section is not applicable. There is no "training set" as this is not an AI/ML device. The tests performed are to evaluate manufactured products against predefined specifications.

9. How the Ground Truth for the Training Set Was Established:

This section is not applicable for the same reason as point 8.

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