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A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hands or fingers to prevent contamination between patient and examiner.

POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES

Here's a breakdown of the acceptance criteria and study information for the "POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES" based on the provided document:

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 specific sample sizes for each test in the "test set." However, it references established industry standards:

• Tensile Strength & Elongation: Tested according to ASTM D412.
• Freedom from Holes: Tested according to ASTM D5151 (Water Leak Test) and FDA 21 CFR 800.20 (Acceptance Quality Limit - AQL). The AQL of 2.5 implies a sampling plan based on lot size, which dictates the number of units to be inspected and the maximum allowable number of failures.
• Biocompatibility: Tested according to ISO 10993-10 (Dermal Sensitization and Primary Skin Irritation).

The data provenance is not explicitly stated in terms of country of origin for the performance tests, but the manufacturer is "Comfort Rubber Gloves IND. SDN. BHD." from Malaysia. The tests are prospective in nature, as they are performed on the device to demonstrate compliance.

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

This information is not applicable to this type of device (patient examination gloves). The "ground truth" for these tests is established by objective, standardized measurements and laboratory assessments, not by expert consensus or interpretation of images. For example, tensile strength is measured quantitatively, and freedom from holes is determined by a physical water leak test.

4. Adjudication Method for the Test Set

This information is not applicable. The performance criteria for patient examination gloves are based on objective physical and chemical testing, not on adjudicated readings or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not applicable and therefore not done. This type of study is relevant to AI/diagnostic imaging devices where human readers interpret data, and the AI's impact on their performance is evaluated. This device is a physical medical device (examination glove), and its performance is assessed through standardized laboratory tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This device is a physical product, not an algorithm, so the concept of "standalone performance" for an algorithm does not apply.

7. The Type of Ground Truth Used

The ground truth used for this device's performance evaluation is based on:

• Objective physical measurements: For tensile strength and elongation.
• Adherence to established quality limits: For freedom from holes (AQL 2.5).
• Standardized laboratory biological assays: For dermal sensitization and primary skin irritation (ISO 10993-10).

Essentially, the "ground truth" is defined by the performance requirements outlined in the relevant ASTM, FDA, and ISO standards that the device must meet.

8. The Sample Size for the Training Set

This information is not applicable. The device is a manufactured product, not an AI model that requires a "training set." Its performance is directly assessed through testing of manufactured samples.

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

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

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A powder-free patient examination glove is a disposable device made of synthetic material that is intended for medical purposes to be worn on the examiner's hand or finger(s) to prevent contamination between patient and examiner.

POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES

The provided text is a 510(k) Premarket Notification from the FDA for "Powder Free Nitrile (Blue and White) Examination Gloves." This document DOES NOT describe acceptance criteria or a study proving the device meets those criteria.

Instead, a 510(k) submission primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This equivalence is typically based on:

• Same intended use.
• Same technological characteristics, OR
• Different technological characteristics but does not raise different questions of safety and effectiveness AND is as safe and effective as the predicate device.

For devices like examination gloves, equivalence is often established by demonstrating compliance with recognized consensus standards (e.g., ASTM standards for physical properties, barrier integrity, and biocompatibility). The FDA letter confirms the device's substantial equivalence to a predicate, allowing it to be marketed, but does not detail the specific performance criteria or studies that led to this determination within the provided text.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC comparative effectiveness studies from the provided text. This type of information would typically be found in the actual 510(k) submission document itself, not in the FDA's decision letter.

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