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The Palm-Pro Powder Free Nitrile Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." (21CFR 880.6250)

Nitrile latex films form a barrier to body fluids and bloodborne pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile rubber is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided text describes information about powdered free nitrile examination gloves and does not mention anything about AI/ML device.

However, based on the information provided in the document, here's a breakdown of the acceptance criteria and the study that proves the device meets the criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for the non-clinical or clinical tests.

• Data Provenance: The device is manufactured by Dipped Products (Thailand) Ltd, located in Thailand. The tests were likely conducted in Thailand or by contractors on behalf of the manufacturer. The document doesn't specify if the tests were retrospective or prospective, but clinical tests are generally prospective by nature.

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

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth, particularly for the clinical safety tests (Rabbit Irritation and Guinea Pig Sensitization). These types of tests typically follow established laboratory protocols rather than relying on expert consensus for "ground truth" in the way an AI model might.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method. This is not relevant for this type of device testing, which relies on standardized objective measurements (ASTM for physical properties) and established biological testing protocols (for irritation and sensitization).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human readers interpret data, and the AI assists in that interpretation. This submission is for a physical medical device (examination gloves).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, a standalone (algorithm only) performance study was not done. This is not applicable to a physical medical device.

7. The Type of Ground Truth Used:

• Non-Clinical Tests (Water Tightness): The "ground truth" is defined by the performance standards set by ASTM D6319-10 and ASTM D5151-92. These standards outline the methodology and acceptance criteria for water leak tests in medical gloves.
• Clinical Tests (Safety - Rabbit Irritation, Guinea Pig Sensitization): The "ground truth" for these tests is based on established biological testing protocols designed to assess the potential for irritation and sensitization. A "Passes" outcome indicates that the device did not induce a significant adverse reaction according to the specific criteria of these protocols.

8. The Sample Size for the Training Set:

Not applicable. This submission is for a physical medical device, not an AI/ML device that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

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A powder-free patient examination glove is a disposable device made of natural rubber latex material that may bear a trace amount of glove powder and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

A non-sterile, disposable, patient examination glove made of natural rubber latex, powder-free, with or without polymer coating.

The provided document describes the 510(k) summary for the Palm-Pro and Palm-Pro Premium Powder-Free Latex Examination Gloves. These gloves are Class I devices and their acceptance criteria and performance are outlined in relation to established ASTM standards and FDA regulations.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each of the non-clinical tests (Dimensions, Physical Properties, Freedom from pinholes, Powder-Free, Protein level, Biocompatibility).

Regarding data provenance, the document states: "The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above." This implies that the tests were conducted by the manufacturer, Dipped Products (Thailand) Limited (located in Sri Lanka and Thailand), to demonstrate compliance with the specified ASTM standards and FDA regulations. The nature of these tests (e.g., in-house testing) generally leans towards prospective data collection for product qualification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the device is a Class I medical device (patient examination gloves). The evaluation relies on meeting established engineering and material science standards (ASTM) and regulatory requirements (FDA 21 CFR 800.20), rather than expert interpretation of medical images or diagnostic data. Therefore, there's no "ground truth" derived from medical experts in the context of diagnostic performance.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in studies involving expert interpretation of data where discrepancies need to be resolved. For device performance against engineering standards, the results are typically quantitative measurements against defined thresholds.

5. 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

This section is not applicable. The device is a physical product (gloves) and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical product and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device is the defined specifications and thresholds within the ASTM standards and FDA regulations. For example:

• Dimensions: Measured values compared against the ranges specified in ASTM D 3578-01a.
• Physical Properties: Tensile strength, elongation, etc., measured and compared against ASTM D 3578-01a.
• Freedom from pinholes: Testing according to ASTM D-3578-01a and FDA 21 CFR 800.20.
• Powder-Free level: Gravimetric measurement of powder content compared against the < 2mg/glove threshold according to ASTM D 6124-01.
• Protein level: Measured protein content according to ASTM D-5172-95 compared against the < 50μg/g threshold.
• Biocompatibility: Results of standardized primary skin irritation and dermal sensitization tests.

8. The sample size for the training set

This section is not applicable. This is a physical product and does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

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

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