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A powderfree patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against poetentially infectious and other contaminants.

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This document is a 510(k) premarket notification FDA letter for examination gloves. As such, it does not contain the detailed information required to describe the acceptance criteria and the study proving a device meets those criteria in the way envisioned by the prompt (which is more typical for AI/software as a medical device).

However, I can extract the information that is present and explain why other requested information is not available in this type of document.

Here's an analysis based on the provided text, addressing the points you requested:

Acceptance Criteria and Device Performance for Shanghai Huamao Powder-Free Yellow Vinyl Examination Gloves (K024154)

This 510(k) premarket notification primarily focuses on establishing "substantial equivalence" of the Shanghai Huamao Powder-Free Yellow Vinyl Examination Gloves to predicate devices. For medical devices like gloves, "acceptance criteria" and "device performance" in a 510(k) context generally refer to meeting recognized standards (e.g., ASTM standards for physical properties, biocompatibility, etc.) and demonstrating that the new device is as safe and effective as a legally marketed predicate. The provided text does not include a table of specific acceptance criteria or detailed performance data from testing. The FDA letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the manufacturer provided data in their full submission that demonstrated compliance with relevant performance standards, but this detailed data is not part of this summary FDA letter.

Here's what can be inferred or stated about the requested points:

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Inferred): For examination gloves, acceptance criteria typically involve meeting established ASTM standards for properties such as tensile strength, elongation, puncture resistance, barrier integrity (freedom from holes), and biocompatibility. The specific thresholds for these would be defined in those standards. The document does not explicitly list these criteria or values.
   • Reported Device Performance: The document states that the device was found "substantially equivalent" to predicate devices. This implies that the submitted performance data met the necessary standards, but the actual performance values are not reported in this letter.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This information is not available in the provided FDA letter. The 510(k) summary (or full submission) would contain details on test methods, sample sizes, and data provenance.
   • The manufacturer is "Shanghai Huamao Gloves Company Limited" in "Shanghai, China," implying the manufacturing origin, but not necessarily the origin of the performance test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This concept is typically relevant for interpretative devices (e.g., AI for medical imaging) where human expert consensus defines the "ground truth." For a physical device like an examination glove, "ground truth" is established through objective, standardized physical and chemical testing (e.g., tensile testing, leak testing, biocompatibility assays). Therefore, the concept of "experts establishing ground truth" in the sense of clinical interpretation does not apply here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Similar to point 3, adjudication methods are used to resolve discrepancies in expert interpretations. Since "ground truth" for gloves is based on objective measurements against standards, adjudication methods are not applicable in this context.

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:

   • MRMC studies are specific to evaluating interpretive devices, often AI-powered, by comparing human reader performance with and without AI assistance. This device is a physical examination glove, not an interpretive device or AI. Therefore, an MRMC study was not performed and is not relevant.

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

   • This refers to the performance of an algorithm without human intervention, again relevant for AI/software devices. Since this is a physical medical glove and not an algorithm, a standalone performance study in this sense was not done and is not applicable.

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

   • For examination gloves, the "ground truth" for performance is based on objective measurements against recognized national and international standards for physical properties (e.g., strength, durability, barrier integrity), biocompatibility (e.g., cytotoxicity, irritation, sensitization), and other relevant properties. There is no "pathology" or "outcomes data" in the typical clinical sense for establishing the fundamental performance of the glove itself.

8. The sample size for the training set:

   • This concept is relevant for machine learning algorithms that require large datasets for training. As this is a physical examination glove, and not an AI/ML device, there is no "training set" in this context.

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

   • As there is no training set for a physical device like an examination glove, this question is not applicable.

Summary of what the document implies about the study for these gloves:

The FDA's determination of "substantial equivalence" means that Shanghai Huamao Gloves Company Limited provided data (in their full 510(k) submission, not shown here) demonstrating that their Powder-Free Yellow Vinyl Examination Gloves meet the same safety and effectiveness criteria as existing, legally marketed predicate gloves. This typically involves:

• Physical testing (e.g., tensile properties, freedom from holes) to relevant ASTM or ISO standards.
• Biocompatibility testing to ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).
• Labeling compliance.
• Material composition comparison with predicate devices.

The FDA letter itself is a regulatory confirmation, not a detailed scientific study report.

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A patient examination glove is a disposable device intended for medical purposes that is worr 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 a disposable device intended for medical purposes 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. Powder-free Vinyl Patient Examination Glove, 80LYZ and meets all requirements of ASTM Standard D5250-92.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the SHANGHAI HUAMAO GLOVES CO., LTD. Powder-free Vinyl Patient Examination Gloves:

The document is a 510(k) summary for a medical device submitted to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and performance metrics in the typical sense of a clinical trial. However, we can extract the relevant information regarding the standards and tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • For ASTM D5250-92 Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (Specific number of units tested is not provided, but these are standard sampling plans.)
  • For FDA 1000 ml. Water Fill Test: Inspection Level S-4, AQL 2.5. (Specific number of units tested is not provided.)
  • For Primary Skin Irritation and Skin Sensitization: Not specified, but generally involves a set number of human subjects or animal models according to standard protocols.
  • For USP Iodine Test/Powder Residue/Light Transmission: Conducted at finished inspection and final release; specific sample sizes for these internal quality control tests are not provided in this summary.
• Data Provenance: The device is manufactured by SHANGHAI HUAMAO GLOVES CO., LTD. in Shanghai, China. The testing was presumably conducted by or for the manufacturer. The data is retrospective in the sense that it summarizes tests already performed on manufactured batches.

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

This document does not describe a scenario where experts established ground truth in the context of a typical diagnostic or AI study. The "ground truth" here is defined by meeting established regulatory standards (ASTM, FDA water fill test, USP, biocompatibility tests). These standards have predetermined pass/fail criteria, often implemented by trained technicians or quality control personnel in a laboratory setting. There isn't a "consensus of experts" forming a ground truth here.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements against defined standards (e.g., AQL levels for defects, specific chemical tests, physical property limits). There is no "adjudication" between multiple expert opinions, as the assessment is based on direct measurement against a standard.

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

No, an MRMC comparative effectiveness study was not done. This device is a Class I medical device (patient examination gloves) and the submission focuses on demonstrating substantial equivalence through performance against established material and safety standards, not on evaluating human reader performance with or without AI assistance.

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

Not applicable. This is not an AI/algorithm-driven device. The "performance" is the physical and chemical properties of the gloves themselves.

7. The Type of Ground Truth Used

The ground truth is based on regulatory standards and established test methodologies (e.g., ASTM D5250-92 for physical properties, FDA 1000 ml. Water Fill Test for barrier integrity, USP Iodine Test for powder content, and biocompatibility standards for skin irritation/sensitization). These are objective, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set" in that context. The "training" in manufacturing refers to adherence to good manufacturing practices and quality control processes to ensure consistency.

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

Not applicable, as there is no training set for an AI model. The manufacturing process itself (which could be loosely considered "training" if one were to stretch the analogy) is validated by adhering to established quality management systems (like GMP - Good Manufacturing Practice, mentioned in the FDA letter). The ground truth for successful manufacturing is producing gloves that consistently meet the specifications outlined in the standards (ASTM, FDA, USP, etc.).

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A glove 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 a disposable device intended for medical purposes 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, Pre-powder Vinyl Patient Examination Glove, 80LYZ, powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

Here's an analysis of the provided text to extract the acceptance criteria and study information, formatted as requested:

Device: SHANGHAI HUAMAO GLOVES CO., LTD. Pre-powder Vinyl Examination Gloves

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Physical and Dimensions Testing): Not explicitly stated as a number, but "Inspection Level S-2, AQL 4.0" is mentioned, which refers to a sampling plan for inspection.
• Sample Size (FDA 1000 ml. Water Fill Test): Not explicitly stated as a number, but "samplings of AQL 2.5, Inspection Level S-4" is mentioned, which refers to a sampling plan for inspection.
• Data Provenance: The device manufacturer is SHANGHAI HUAMAO GLOVES CO., LTD. in Shanghai, China. The testing was conducted based on ASTM standards (likely in China or by a certified lab). It is implicitly retrospective as it's a premarket notification for a manufactured product.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical product (examination gloves), and its performance is evaluated against established technical standards (ASTM, FDA water fill test, biocompatibility). Expert consensus for "ground truth" in the way it's used for AI or diagnostic devices is not relevant here. The evaluation is based on objective measurements and tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). The tests conducted here (physical dimensions, water fill, irritation, sensitization) are objective.

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 a diagnostic device or an AI-assisted tool. It's a medical device (examination glove) with performance evaluated against industrial and regulatory standards.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" in this context refers to the specified values and requirements set by the adopted standards:

• ASTM Standard D5250-92: This standard defines the physical properties and dimensions for vinyl patient examination gloves.
• FDA 1000 ml. Water Fill Test: This is a specific FDA requirement for assessing pinhole defects in gloves.
• Biocompatibility Standards: These standards (implied, as "biocompatibility requirements" are mentioned) define acceptable levels of skin irritation and sensitization.

Essentially, the ground truth is defined by the established performance specifications and testing methodologies outlined in the regulatory and industry standards.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI models, so there is no training set. The "training set" concept is irrelevant for a physical product like examination 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.

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