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Powder free vinyl 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.

Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)

This document is a 510(k) premarket notification decision letter from the FDA for Powder Free Vinyl Patient Examination Gloves. It does not contain information about acceptance criteria or performance studies of a device in the traditional sense of AI/Software as a Medical Device (SaMD) evaluations.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance. This substantial equivalence is typically demonstrated through comparing the device's technological characteristics and performance to a predicate device, as outlined in FDA guidance for medical devices, particularly for accessories like examination gloves.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this document does not contain that type of technical performance evaluation for a software or AI device. The "performance" in this context refers to the physical properties of the gloves (e.g., integrity, strength) and their intended use as a barrier, not to an algorithm's diagnostic or predictive capabilities.

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Powdered vinyl 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.

powdered vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-0064

Here's a breakdown of the acceptance criteria and the study information for the "Powdered Vinyl Patient Examination Gloves, Clear (Non-colored)" based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes premarket notification (510(k)) information for patient examination gloves. It relies on non-clinical testing to demonstrate substantial equivalence to a predicate device.

1. Sample Sized Used for the Test Set and the Data Provenance:
* Sample Size: The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for pinholes, physical properties, or biocompatibility). It broadly states that the device "meets" the requirements of the standards.
* Data Provenance: The tests are likely conducted by the manufacturer, JIANGSU EVERYGUARD PLASTIC PRODUCTS CO., LTD, or a contracted lab. The document does not specify the country of origin of the raw data, but the manufacturer is based in China. The data is retrospective as it was conducted to support the 510(k) submission.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
* This is not applicable to this type of device and study. The "ground truth" for glove performance is established by adherence to recognized national and international standards (ASTM D 5250-00e4, 21 CFR 800.20, ASTM D6124-01, ISO10993-10), not by expert consensus on clinical findings.

3. Adjudication Method for the Test Set:
* This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnoses, not for performance testing of
* patient examination gloves against specified engineering and biocompatibility standards. The results of the tests (e.g., whether a glove tears under a certain force, or if it has pinholes exceeding a certain AQL) are objective and do not require adjudication.

4. 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 is not applicable. The device is a patient examination glove, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI are irrelevant.

5. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
* This is not applicable. The device is a physical product (a glove), not a software algorithm.

6. The Type of Ground Truth Used:
* The "ground truth" is defined by the objective scientific and engineering standards themselves:
* ASTM standard D 5250-00e4 for physical properties, dimensions, and powder amount.
* 21 CFR 800.20 for freedom from pinholes (waterleak test).
* ASTM D 6124-01 (implied for powder residue from the statement "per ASTM D6124-01" in the nonclinical discussion).
* ISO10993-10 for biocompatibility (specifically primary skin irritation and dermal sensitization).
* Pre-defined Pass/Fail criteria within these standards.

7. The Sample Size for the Training Set:
* This is not applicable. There is no concept of a "training set" for the evaluation of a physical device like a glove. The testing is manufacturing-process oriented, ensuring conformity to standards for each batch or lot, or for initial design validation.

8. How the Ground Truth for the Training Set was Established:
* This is not applicable, as there is no "training set." The ground truth for the performance evaluation is established by the validated test methods outlined in the aforementioned ASTM, ISO, and CFR standards.

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