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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands 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, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirement of ASTM Standard D5250-06.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:

Device: Zibo Intco Medical Products, Co. Ltd. Powder-free Vinyl Patient Examination Gloves, Yellow Color

1. Table of Acceptance Criteria and Reported Device Performance

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

• Physical and Dimensions Testing, Pinhole Results: Inspection Level S-2, AQL 2.5 for physical/dimensions and Inspection Level I, AQL 2.5 for the FDA 1000 ml. Water Fill Test (pinhole). The specific number of gloves tested is implicitly defined by these AQL (Acceptable Quality Limit) levels and inspection levels, but the exact sample number isn't stated directly. For pinhole, it specifies "125 pieces gloves" were tested.
• Residual Powder: Not explicitly stated, but performed according to ASTM D6124-06.
• Biocompatibility (Primary Skin Irritation, Skin Sensitization): Not explicitly stated, but testing was conducted.
• Data Provenance: The testing was performed by Zibo Intco Medical Products, Co. Ltd. in China, as per the submitter's identification. The data is retrospective, as it's part of a 510(k) submission showing pre-market testing.

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

This type of information is not applicable to this device. The "ground truth" for glove performance characteristics like tensile strength, pinholes, or powder content is established by standardized testing methods (e.g., ASTM standards) and objective measurements, not by expert consensus or clinical interpretation. Biocompatibility testing results (irritation/sensitization) are also objective findings from laboratory tests, not expert interpretation.

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are objective laboratory measurements, not subjective evaluations requiring adjudication.

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

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and the AI's impact on their performance is being assessed. This device is a medical glove, which does not involve human interpretation in the same way.

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

No, a standalone study (in the context of AI algorithms) was not done. This device is a physical product (medical glove), not an algorithm or AI software. The performance testing focuses on the physical properties and biological compatibility of the glove itself.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Standardized Measurement: Adherence to established performance standards defined by ASTM (American Society for Testing and Materials) such as D5250-06, D6124-06, and D5151-06.
• Laboratory Testing: Objective results from physical, chemical, and biological laboratory tests (e.g., tensile strength, elongation, residual powder measurement, water fill test for pinholes, primary skin irritation test, skin sensitization test).

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical product, not a machine learning model or algorithm, so there is no "training set" in the computational sense. The testing performed is to validate the manufacturing process and product characteristics.

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

This information is not applicable for the reasons stated in point 8.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.(21 CFR 880.6250)

Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Examination Vinyl Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.

The provided 510(k) summary is for the Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue. As such, the "device" in this context refers to these gloves. This document describes the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study of an AI algorithm. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable to this type of medical device submission.

Here's the information extracted from the document, focusing on the acceptance criteria and the study (non-clinical testing) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on the ASTM-D-5250-06 standard for examination vinyl gloves, and FDA requirements for pinholes and biocompatibility. The reported device performance is compared to the predicate device, which implicitly meets these standards.

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

• Sample Size: Not explicitly stated as a single "test set" sample size. For physical and dimensions testing, the inspection levels are S-2, AQL 2.5. For the FDA 1000 ml. Water Fill Test (pinhole), the inspection level is I, AQL 2.5. These are industry standard sampling plans, but the specific number of gloves sampled is not provided in this summary.
• Data Provenance: The tests were conducted by Zibo Intco Medical Products, Co. Ltd. (the manufacturer) in China. The data is prospective, generated specifically for this submission.

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

Not applicable. This is not an AI/diagnostic device that requires expert ground truth establishment in the traditional sense. The "ground truth" for glove performance is determined by established engineering and material science standards (ASTM, FDA water fill test).

4. Adjudication method for the test set

Not applicable. This is not an AI/diagnostic device. Performance is measured against objective standards.

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 is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on:

• Industry Standards: ASTM D5250-06 for physical properties and dimensions.
• Regulatory Requirements: FDA 1000 ml. Water Fill Test for pinhole integrity.
• Biocompatibility Testing: Primary Skin Irritation and Skin Sensitization tests (in vivo tests on biological systems, typically animals or human volunteers for patches, but the document doesn't specify for this case, only "with results showing no primary skin irritant or sensitization reactions").
• Chemical Analysis: Measurement of powder content (no more than 2 mg/glove).

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set.

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

Not applicable.

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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)

Patient Vinyl Examination Gloves, Powderfree, Non-Sterile

The provided document is a 510(k) premarket notification letter from the FDA regarding Patient Vinyl Examination Gloves. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information.

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