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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.

POWDERED VINYL EXAM GLOVES, WHITE, Class I Device, 80LYZ. 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.

The provided text describes the regulatory clearance for "POWDERED VINYL EXAM GLOVES, WHITE" (K030927) and references its substantial equivalence to another device (K021961). The acceptance criteria for medical gloves are typically defined by recognized standards such as ASTM. The document states that the device met or exceeded specific ASTM standards and other tests.

Here's the breakdown of the requested information based on the provided text:

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

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

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). This information is typically detailed in the full test reports, which are not included here.

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 information is not provided in the document. Testing for medical gloves (physical properties, biocompatibility) typically involves laboratory testing against established standards, not necessarily relying on expert "ground truth" panels in the same way an AI diagnostic tool might.

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

This information is not applicable for the type of device and testing described. The performance is assessed against standardized objective measurements defined by ASTM, ISO, and MIL standards, not subjective adjudication.

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

No such study was conducted or mentioned. This type of study is relevant for AI-powered diagnostic tools where human interpretation is assisted by AI, which is not the case for examination gloves.

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

This is not applicable for an examination glove. There is no algorithm or AI component in this device. The device itself (the glove) is the standalone entity being evaluated for its physical and biocompatibility properties.

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

The "ground truth" for examination gloves is defined by the objective, measurable performance requirements specified in the referenced ASTM, ISO, and MIL standards for physical properties (e.g., tensile strength, elongation, barrier integrity) and validated laboratory tests for biocompatibility (dermal sensitization, primary skin irritation, bioburden).

8. The sample size for the training set

This is not applicable as this device is an examination glove and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no training set for this device.

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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.

POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE

This submission is for "POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE". The device is a Class I medical device (80LZA).

Here's the breakdown of the acceptance criteria and study 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 specify a separate "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The studies refer to meeting or exceeding ASTM standards and biocompatibility tests, which imply a defined methodology within those standards for sample selection and testing.

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

This information is not applicable. The device is an examination glove, and its performance is assessed against technical standards (ASTM) and biological safety tests (biocompatibility, bio-burden), rather than requiring expert interpretation of diagnostic output to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device and study. The testing involves laboratory measurements against established standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted devices where human readers interpret medical images or data. The device in question is an examination glove.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. The device is a physical product (examination glove), not an algorithm or AI system. Its performance is assessed through physical and biological testing.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is defined by the specifications and pass/fail criteria outlined in the referenced ASTM standards (D 5250-00, D 5151-00, D 6124-00) and the acceptable levels for Bio-Burden, Dermal Sensitization, and Primary Skin Irritation. These standards represent scientifically established benchmarks for glove quality and safety.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for this device.

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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.

POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study conducted for the Powder-Free Poly-Vinyl Exam Gloves:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each of the tests (ASTM D 5250-00, D 5151-00, D 6124-00, Bio-Burden, Dermal Sensitization, Primary Skin Irritation). For medical device testing, these ASTM standards and biocompatibility tests typically involve specific sample size requirements.

The data provenance is also not explicitly stated. While the manufacturer is based in Taiwan, and the submitter is in the US, the location where the tests were performed is not mentioned. The document does not indicate whether the data was retrospective or prospective.

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

The document does not mention using experts to establish ground truth for the test set. The tests performed are objective, laboratory-based tests against established ASTM standards and biological safety criteria. These types of tests do not typically rely on subjective expert consensus for "ground truth" in the same way an imaging diagnostic algorithm might.

4. Adjudication Method for the Test Set:

An adjudication method is not applicable here. The tests are objective, with pass/fail criteria based on the specified ASTM standards and biological safety assessments. There is no subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images and the AI's impact on their performance is evaluated. The device in question is a patient examination glove, and its performance is assessed through physical and biological property testing, not diagnostic interpretation.

6. Standalone Performance Study:

Yes, a standalone study was done. The entire set of tests listed (ASTM D 5250-00, ASTM D 5151-00, ASTM D 6124-00, Bio-Burden, Dermal Sensitization, Primary Skin Irritation) represents the standalone performance evaluation of the device. These tests were conducted on the gloves themselves to demonstrate that they meet the specified standards and safety requirements. The performance reported in the table reflects the algorithm-only (device-only) performance against the established criteria.

7. Type of Ground Truth Used:

The "ground truth" for the performance evaluation is based on established industry standards and biological safety criteria.

• ASTM D 5250-00, D 5151-00, D 6124-00: These are ground truths based on published consensus standards for material properties, barrier integrity, and residual powder.
• Bio-Burden: Ground truth would be acceptable limits for microbial contamination.
• Bio-Compatibility (Dermal Sensitization, Primary Skin Irritation): Ground truth is established biological safety thresholds and responses (e.g., absence of irritation or sensitization reactions in test subjects/models).

8. Sample Size for the Training Set:

This information is not applicable/not provided. The device is a physical product (examination gloves), not an artificial intelligence or machine learning algorithm that requires a "training set" of data. The manufacturing process itself is implicitly 'trained' through quality control and process validation, but this is distinct from an AI training set.

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

This information is not applicable as there is no "training set" for this type of device.

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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.

PATIENT EXAMINATION GLOVE, POLY (VINYL), POWDER FREE

This document is a 510(k) clearance letter from the FDA for a Poly (Vinyl) Examination Glove, Powder-Free, and primarily discusses regulatory approval. It does not contain information about specific technical acceptance criteria, a study proving performance, sample sizes for testing or training, expert qualifications, or ground truth methodologies for an AI/device performance study. Therefore, I cannot extract the requested information from the provided text.

The closest information available is the "Indications For Use" which describes the intended purpose of the glove: "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." This states what the device is for, but not directly measurable performance criteria from a study.

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This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

CAP, BOUFFANT, NURSES SURGICAL WHITE, BLUE, & GREEN

This looks like a 510(k) clearance letter for a very low-risk device (nurses' bouffant cap) from 1997. It doesn't contain the extensive information you're asking for regarding acceptance criteria or detailed study results because such reports are typically not required for Class I devices cleared through predicate equivalence.

Here's why and what can be extracted:

Why the requested information is absent:

• Device Classification (Class I): Nurses' bouffant caps are classified as Class I devices. These devices are considered to pose the lowest risk to patients and users.
• 510(k) Clearance: For Class I and many Class II devices, the FDA clears them based on "Substantial Equivalence" to a legally marketed predicate device. This means the manufacturer demonstrates that their new device is as safe and effective as a device already on the market.
• Lack of Performance Studies: For low-risk devices like this, the FDA typically does not require comprehensive clinical studies or even extensive bench testing with detailed acceptance criteria and performance metrics. The demonstration of substantial equivalence often relies on:
  • Comparison of technological characteristics (materials, design, intended use).
  • Verification of manufacturing processes to ensure quality and consistency.
  • For something like a cap, basic safety (e.g., non-toxic materials, no sharp edges) and functionality (e.g., stays on, covers hair).

What can be extracted/inferred from the provided text:

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

   • Acceptance Criteria: Not explicitly stated in the provided documents. For a bouffant cap, criteria would be very basic, likely related to physical integrity, material composition, and fit.
   • Reported Device Performance: Not explicitly stated. The device is intended "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." The performance is implicitly assumed to be equivalent to existing predicate bouffant caps.

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

   • Not applicable/Not provided. Detailed test sets and data provenance for performance are not typically required for this type of clearance.

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/Not provided. There's no "ground truth" to establish for a device like this in the context of clinical performance.

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

   • Not applicable/Not provided.

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/software device.

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

   • Not applicable. This is not an AI/software device.

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

   • Not applicable. The "ground truth" for a bouffant cap would be its ability to physically contain hair and particulate matter, and its material safety, which are typically assessed through standard material testing and visual inspection, not complex clinical "ground truth."

8. The sample size for the training set:

   • Not applicable/Not provided. There is no AI model or complex algorithm requiring a training set for this device.

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

   • Not applicable/Not provided.

Summary based on the provided document:

The document is a 510(k) clearance letter confirming that the "Nurses Bouffant Cap" is substantially equivalent to a predicate device. This clearance is based on the device's classification as a low-risk, Class I device (Product Code: LYU) and the presumption that it meets general controls for manufacturing and labeling. Formal performance studies with detailed acceptance criteria, test sets, or expert ground truths, as would be required for higher-risk or novel devices, are not present in this type of regulatory submission. The "Indications For Use" state the device's purpose: "to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." This functional intent is the closest equivalent to a performance goal, but no specific performance metrics are provided.

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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.

PATIENT EXAMINATION GLOVE, POLY (VINYL), POWDERED

The provided text is a 510(k) premarket notification letter from the FDA regarding a Patient Examination Glove. This document primarily addresses the substantial equivalence of the device to legally marketed predicate devices and outlines general regulatory compliance.

It does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or any analytical or clinical performance data typically associated with a "device" in the context of AI tools or diagnostics.

Therefore, I cannot extract the requested information as it is not present in the provided document. The sections you asked for, such as sample size, ground truth establishment, expert qualifications, and AI-related performance metrics, are entirely absent.

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