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The Vinyl Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl examination gloves. The subject device's color is yellow. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.

This document describes the regulatory approval for "Disposable, vinyl examination gloves, Yellow" and focuses on non-clinical testing for equivalence. Therefore, it does not contain the information requested for a study proving device performance against acceptance criteria in the context of an AI/medical imaging device.

The provided text pertains to a Class I medical device (disposable vinyl examination gloves) and its 510(k) submission for substantial equivalence to a predicate device. The information requested (acceptance criteria and study details for an AI-powered device or diagnostic tool) is not applicable to this submission.

However, I can extract the acceptance criteria and reported device performance from the "Summary of Non-clinical Testing" section (Table 2) in the document, which are related to the physical and biocompatibility properties of the gloves.

Here's a breakdown of the available information based on your request, with the understanding that it will not completely align with the format for AI/diagnostic studies:

1. Table of Acceptance Criteria and the Reported Device Performance

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The Vinyl Examination Gloves(Yellow) are disposable device intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is non-sterile.

The provided document is a 510(k) premarket notification for Vinyl Examination Gloves, a Class I medical device. This type of device does not involve AI or complex software, and thus the request asking about AI/algorithm performance metrics is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through physical and biological testing, not through AI/algorithm performance.

Therefore, many of the requested points regarding AI/algorithm performance, such as sample size for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment for AI models, cannot be extracted from this document as they are not relevant to the device being described.

However, I can extract the acceptance criteria and performance data for the physical properties of the gloves, as well as the non-clinical testing information:

Description of Acceptance Criteria and Study Proving Device Meets Criteria (for Vinyl Examination Gloves)

This document describes the non-clinical testing performed to demonstrate that the Vinyl Examination Gloves (Yellow) are substantially equivalent to a legally marketed predicate device (K163168). The acceptance criteria are based on recognized standards for medical gloves, primarily ASTM D5250, ASTM D5151, and ASTM D6124, as well as biocompatibility standards ISO 10993-5 and ISO 10993-10.

1. Table of Acceptance Criteria and Reported Device Performance

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The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

This document is a 510(k) summary for Vinyl Examination Gloves (Yellow). It does not describe an AI/ML device. Therefore, the requested information about acceptance criteria, study details, human reader improvement, standalone performance, ground truth, and training set information is not applicable.

The document assesses the substantial equivalence of the Vinyl Examination Gloves (Yellow) to a predicate device (Hebei Hongtai Plastic Products Company Limited's Vinyl Patient Examination Gloves (White, Blue, Yellow), K163168).

The comparison focuses on physical dimensions, performance properties, material, and biocompatibility, demonstrating that the new device meets relevant ASTM and ISO standards for vinyl examination gloves.

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The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

This FDA 510(k) summary is for a Vinyl Examination Glove and does not describe an AI/ML powered medical device. Therefore, it does not include the detailed information typically associated with such device evaluations, such as studies on acceptance criteria, reader performance, or ground truth establishment.

However, I can extract the acceptance criteria and performance data for this traditional medical device based on the provided document.

Acceptance Criteria and Device Performance (Vinyl Examination Gloves):

The acceptance criteria are primarily defined by adherence to recognized international and national standards for medical gloves, and comparability to the predicate device. The performance data is presented in the context of these standards and comparisons.

Since this document is for a traditional medical device (Vinyl Examination Gloves) and not an AI/ML powered device, the following points are not applicable or the information is not provided in the document:

2. Sample size used for the test set and the data provenance: The document mentions "test results" for physical and biological properties, but it does not specify the sample size for these tests. The provenance of the data is implied to be from the manufacturer (XINYING TRADING CO.,LTD.) in China, for the device manufactured there.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of device. Ground truth is established by standardized testing protocols (e.g., ASTM, ISO) and laboratory results, not expert consensus in the clinical sense.

4. Adjudication method: Not applicable. Performance is based on objective measurements against established 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 as this is not an AI/ML-powered device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is not an AI/ML-powered device.

7. The type of ground truth used: The "ground truth" for this device's performance is derived from compliance with recognized performance standards (ASTM D5250, ASTM D5151, ASTM D6124) and biocompatibility standards (ISO 10993-10, ISO 10993-5) through laboratory testing.

8. The sample size for the training set: Not applicable as this is not an AI/ML-powered device requiring a training set.

9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML-powered device requiring a training set.

Summary of the Study that Proves Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed in the "Non-Clinical Test Conclusion" (Section 8.0). The device was tested for compliance with the following standards:

• ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization: This standard was used to demonstrate that the glove is not an irritant or sensitizer.
• ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity: This standard was used to show that the glove did not exhibit potential toxicity to L-929 cells.
• ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves: This standard confirms the powder content within acceptable limits for a powder-free glove.
• ASTM D5151-06 (Reapproved2015), Standard Test Method for Detection of Holes in Medical Gloves: This standard ensures the integrity of the gloves (freedom from holes).
• ASTM D5250-19, Standard Specification for Poly (vinyl chloride) Gloves for Medical Application: This is a comprehensive standard covering general physical requirements such as tensile strength, ultimate elongation, and dimensions.

The document states that the "test results demonstrated that the proposed device complies with the following standards," suggesting that the performance metrics listed in Table 3 and Table 4 were obtained through testing against these specified standards. The comparison to the predicate device (Hebei Hongtai Plastic Products Company Limited's Vinyl Patient Examination Gloves K163168) further supports the substantial equivalence claim by showing similar technological characteristics and performance within the established standards, even with some numerical differences in physical properties like tensile strength and elongation, which were deemed to still meet ASTM D5250 and thus not raise new safety or performance questions. Clinical testing was not deemed necessary for this device (Section 9.0).

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The Vinyl Examination Gloves (White, Blue, or Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is Powder Free Vinyl Patient Examination Gloves. The proposed device is available in three different colors: White, Blue, and Yellow. The proposed device was tested according to the following standards: ASTM D 6124-06, ASTM D 5151-06, ASTM D5250-06, ISO 10993-10:2010 and ISO 2859-1:2009.The proposed device is non-sterile.

The provided document is a 510(k) Pre-market Notification for Vinyl Examination Gloves. This type of device is a Class I medical device, which falls under general controls and does not typically require extensive clinical data or complex performance studies like those seen for higher-risk devices (e.g., AI/ML-driven diagnostic tools).

Therefore, the typical "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of an AI/ML device, as requested in the prompt, are not applicable to this document.

For Vinyl Examination Gloves, "acceptance criteria" primarily relate to material properties, performance standards for physical integrity, and biocompatibility, rather than diagnostic accuracy or human performance improvement. The "study" proving these criteria are met consists of non-clinical, laboratory-based tests.

Here's how to interpret the document in the context of the prompt, while acknowledging the fundamental difference in device type:

Device: Vinyl Examination Gloves (White, Blue, Yellow)
Submission Number: K163168
Predicate Device: K150224 Blue Vinyl Examination Gloves Powder Free

Basis for "Acceptance Criteria" and "Proof":

For this Class I device, "acceptance criteria" are defined by recognized consensus standards to ensure the gloves are safe and effective for their intended use. "Proof" is provided through non-clinical bench testing demonstrating compliance with these standards and comparability to a legally marketed predicate device.

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

Since this is not an AI/ML device, specific "performance" metrics for diagnostic accuracy are not relevant. Instead, the performance metrics relate to the physical and biological characteristics of the gloves. The "acceptance criteria" are the minimum requirements set by the ASTM and ISO standards, and the "reported device performance" indicates that the proposed device met or exceeded these.

Table 1: Acceptance Criteria (Referenced Standards) and Reported Device Compliance

Footnote: The acceptance criteria are largely based on the predicate device's performance and/or compliance with the specified ASTM/ISO standards. Performance shows general compliance and sometimes superior values (e.g., tensile strength for proposed device).

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

• Sample Size: The document does not specify the exact numerical sample sizes for each non-clinical test (e.g., how many gloves were tested for holes or tensile strength). However, it refers to standards like ISO 2859-1 (Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection) for sampling, which implies that appropriate statistically relevant sample sizes were used according to these standards. For biocompatibility, typical animal testing or in-vitro tests are used, but specific numbers are not given.
• Data Provenance: The tests were conducted by the manufacturer, Hebei Hongtai Plastic Products Company Limited, in China ("Hebei Province 055250, China"). The data is retrospective as it was collected prior to the 510(k) submission.

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

• Not Applicable. For a Class I device like examination gloves, "ground truth" as it pertains to medical diagnosis by experts (e.g., radiologists) is not relevant. The "ground truth" for the performance of the gloves is established by the accepted scientific and engineering principles codified in the ASTM and ISO standards (e.g., a hole is a hole as defined by the test method, tensile strength is measured quantitatively). These standards are developed and agreed upon by expert committees in their respective fields (materials science, biocompatibility, etc.).

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

• Not Applicable. As no human experts are performing diagnoses or interpretations to establish ground truth for this device, an adjudication method is irrelevant. The tests are objective, quantitative measurements against predefined 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

• No. An MRMC study is not applicable to a Class I physical device like examination gloves. These studies are typically performed for diagnostic devices (especially AI/ML-driven ones) where human performance (e.g., agreement with ground truth, detection rates) is a key outcome.

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

• Yes, in spirit, but not in the context of an algorithm. The "standalone performance" of the gloves refers to their physical and biocompatibility characteristics when tested independently according to the specified standards. This is what the non-clinical tests (e.g., for holes, tensile strength, irritation) prove. It's the device's inherent properties, without human interpretation or intervention in its diagnostic capability because it has none.

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

• The "ground truth" for these gloves is objective, measurable criteria defined by consensus standards:
  • Physical Parameters: Measurements of length, width, thickness, tensile strength, elongation, and powder content are quantitative and directly measured by standard methods (e.g., ASTM D5250).
  • Integrity: "Freedom from holes" is determined by a standardized test method (ASTM D5151) that objectively detects leaks.
  • Biocompatibility: "Non-irritant" and "non-sensitizer" status is determined by standardized biological evaluation tests (ISO 10993-10), typically involving in-vitro and/or animal testing, not human expert consensus on a subjective finding.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set" in the machine learning sense. The device is manufactured based on a design and then tested against standards.

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

• Not Applicable. There is no "training set" or corresponding "ground truth" establishment process for this type of device.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

DISPOSABLE VINYL EXAMINATION GLOVES, YELLOW COLOR POWDER FREE WITH VITAMIN E

This document is a 510(k) clearance letter from the FDA for disposable vinyl examination gloves. It does not contain information on acceptance criteria or a study proving the device meets those criteria. The document only confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. Therefore, I cannot extract the requested information from the provided text.

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A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETTERN PATIENT AND EXPMINER.

Environ-NF DISPOSABLE SYNTHETIC VINYL EXAM GLOVE, POWDER FREE (YELLOW)

The provided text is a 510(k) clearance letter from the FDA for a medical device: "Environ-NP Powder Free Synthetic Vinyl Examination Gloves." This document is a regulatory approval and does not contain any information regarding acceptance criteria or a study proving the device meets those criteria in the way a performance study for an AI/ML device would.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. The "indications for use" simply describe the intended purpose of the gloves (to prevent contamination between patient and examiner).

Therefore, I cannot provide the requested information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth types, as these are not present in the provided text.

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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 Synthetic Vinyl Examination Gloves, Yellow

This document is a 510(k) clearance letter from the FDA for Powder-Free Synthetic Vinyl Examination Gloves. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document only confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot answer your request based on the provided text.

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