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A disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. This device is single use only.

The Powder-Free Blue Nitrile Examination Gloves Peppermint Scented meets all requirements of ASTM D 6319-10 and FDA 21 CFR 800.20. The device is made out of nitrile.

The provided 510(k) summary (K121528) describes the acceptance criteria and performance of Powder-Free Blue Nitrile Examination Gloves, Peppermint Scented. The study is a non-clinical performance assessment comparing the new device against established standards and a predicate device (K090194).

Here's a breakdown of the requested information:

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 each specific test (e.g., number of gloves tested for pinholes, physical properties, etc.). It only mentions that the device "Meets" the standards, implying that adequate samples were tested to demonstrate compliance.

The data provenance is retrospective and non-clinical. The testing was conducted on samples of the new device and compared against established ASTM standards and the characteristics of a predicate device. The origin of the data (country where tests were performed) is not specified, but the manufacturer is based in China.

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

Not applicable. This device is a medical glove, and the acceptance criteria are based on objective, standardized physical and chemical tests (ASTM standards, FDA regulations), not on subjective expert interpretation of medical images or patient data. Therefore, "ground truth" as established by medical experts is not relevant in this context.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment relies on objective measurements against predefined standards, not on human interpretation requiring adjudication.

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

No. An MRMC study is not relevant for this type of device. This is a non-clinical performance evaluation of a glove, not an imaging diagnostic device or a device requiring human reader interpretation.

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

Not applicable. This device is not an algorithm or an AI-powered system. It is a physical medical device (examination glove). The performance described is its inherent physical and biological characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by established consensus standards and regulatory requirements. Specifically:

• ASTM International Standards: ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves), and ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension).
• FDA Regulations: Specifically, 21 CFR 800.20 ("Patient examination gloves").
• Biocompatibility Testing Guidelines: Primary Skin Irritation and Dermal Sensitization tests are standard biological evaluation methods for medical devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance is evaluated through physical and chemical testing of manufactured gloves.

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

Not applicable, as there is no training set for this type of device. The ground truth for the performance evaluation is established by the referenced ASTM and FDA standards and recognized biocompatibility testing methods.

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