Search Results

A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powered Vinyl Patient Examination Gloves, 80 L YZ, and meets all requirements of ASTM standard D-5250-00E4.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them, structured as requested.

The document describes a 510(k) submission for Powdered (White) Vinyl Patient Examination Gloves. As such, the "device" in this context is a medical glove, not a software algorithm or AI system. Therefore, many of the requested points related to AI/software validation are not applicable.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Specific sample size in units is not provided, but AQL 4.0 refers to a sampling plan for acceptability).

• FDA 1000 ml. Water Fill Test: AQL 2.5, inspection level I. (Specific sample size in units is not provided).

• Primary Skin Irritation and Skin Sensitization: Not explicitly stated, but these are typically performed in vivo (on animal models or human volunteers). The context implies prospective testing specifically for this device.

• Residual Powder Test: Not explicitly stated, but performed at finished inspection.

  Data Provenance: The tests were conducted on the manufacturer's own gloves ("Shijiazhuang Lianhe Shunda Plastic Products Co., Ltd.'s glove production"), indicating a prospective testing approach specific to this device. The country of origin of the manufacturer is China.

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

This information is not applicable as the device is a medical glove, not a diagnostic or prognostic system requiring expert interpretation or ground truth establishment in that typical sense. The "truth" here is determined by objective physical, chemical, and biological tests according to established standards.

4. Adjudication method for the test set:

Not applicable. This concept typically applies to subjective assessments where multiple human readers or experts evaluate data. For physical product testing, the methods are objective applications of test criteria.

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:

Not applicable. This relates to AI/software performance studies. The device is a physical medical glove.

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

Not applicable. This relates to AI/software performance studies. The device is a physical medical glove.

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

The "ground truth" for the glove's performance is established by objective measurements and chemical/biological assays demonstrating compliance with predefined ASTM standards and FDA requirements. For example:

• Physical properties (tensile strength, dimensions) are measured.
• Pinhole presence is determined by liquid leakage.
• Biocompatibility (skin irritation/sensitization) is assessed through standard biological testing.
• Residual powder is measured gravimetrically.

8. The sample size for the training set:

Not applicable. This concept refers to the data used to train an AI model. The device is a physical medical glove, not an AI system.

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

Not applicable. As above, this pertains to AI model development.

Ask a specific question about this device