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A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiners' hands or fingers to prevent contamination between patients and examiners

The Vinyl Examination Gloves are single use only, disposable gloves intended for medical purposes to be worn on the hands or fingers of examiners. The gloves are powder-free, clear and are made of poly vinyl chloride. The gloves are offered non-sterile and are available in small, medium, large and extra-large sizes.

The provided document is a 510(k) Premarket Notification for Powder-Free Clear Vinyl Patient Examination Gloves (K190095). This document is a submission to the FDA (Food and Drug Administration) for a Class I medical device. For such devices, the primary demonstration of meeting acceptance criteria relies on adhering to recognized performance standards and biocompatibility tests.

The document does not describe an AI medical device or a study involving human readers and AI assistance. Therefore, information related to AI-specific criteria (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) is not applicable and is not present in the document.

Instead, the acceptance criteria and performance data pertain to the physical and biological properties of the examination gloves.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for Powder-Free Clear Vinyl Patient Examination Gloves (K190095)

1. Table of Acceptance Criteria and Reported Device Performance:

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

• ASTM D5151-06 (Pinhole/Water Leak Test): 125 gloves were tested for the AQL (Acceptable Quality Level) 2.5 sampling.
• Other standards (e.g., ASTM 5250-06 for physical properties, ASTM D6124-06 for residual powder, ISO 10993 series for biocompatibility): Specific sample sizes for these tests are not explicitly stated within the provided text, but industry standards dictate typical sample sizes for such evaluations.
• Data Provenance: The manufacturer is Anhui Intco Medical Products Co., Ltd., located in Anhui Province, China. The testing was conducted by the manufacturer to demonstrate compliance with international standards. The data is retrospective, generated for this 510(k) submission.

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

• Not Applicable. This document pertains to the physical and biological testing of a medical device (examination gloves), not an AI algorithm that requires expert annotation for ground truth. The "ground truth" here is established by the validated methodologies of the ASTM and ISO standards themselves.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is a submission for a Class I medical device based on performance standards and biocompatibility, there is no "adjudication" in the sense of expert consensus on image interpretation. The results are quantitative and objective measurements against established standard criteria.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is not relevant for the type of device (examination gloves) and the nature of the 510(k) submission.

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

• Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• The ground truth is based on validated methodologies and acceptance criteria defined by international standards such as ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). These standards outline the methods for objectively measuring physical properties (e.g., tensile strength, elongation, dimensions, powder residue, pinholes) and biological responses (e.g., irritation, sensitization, cytotoxicity).

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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

• Not Applicable. There is no "training set" as this is not an AI/ML device.

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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.

A Powder-free Clear Vinyl Patient Examination Gloves 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). Our Powder-free Clear Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, LYZ, and meets all requirement of ASTM Standard 5250-06.

This document is a 510(k) Pre-market Notification for a medical device: Powder-free Clear Vinyl Patient Examination Gloves.

Here's an analysis of the acceptance criteria and study information provided, focusing on the requested elements:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with pass/fail thresholds against which the device is formally judged. Instead, it presents a comparison of the proposed device's characteristics and performance against a legally marketed predicate device (K142703). The "Comparison Conclusion" column often states "Similar," implying that meeting or being comparable to the predicate's performance constitutes the acceptance for substantial equivalence.

Based on the "Technological Characteristic Comparison" table, here's a representation of the implicit acceptance criteria and the reported device performance:

"The Study That Proves the Device Meets the Acceptance Criteria":

The document describes non-clinical tests performed to demonstrate substantial equivalence to the predicate device. These tests align with recognized standards for patient examination gloves.

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

   • Length on Large Size: The specific sample size isn't explicitly stated for the "Average over 232.23mm" measurement.
   • Width of Palm on Large Size: The specific sample size isn't explicitly stated for the "Average 95mm" measurement.
   • Palm Thickness: The specific sample size isn't explicitly stated for the "Average 0.095 mm" measurement.
   • Fingertip Thickness: The specific sample size isn't explicitly stated for the "Average 0.09 mm" measurement.
   • Residual Powder: Not explicitly stated, but the testing was conducted per ASTM D6124-06.
   • Pinhole Results: The test set for pinhole detection was 125 gloves, with the requirement that fewer than two pieces of gloves out of 125 have pinholes to meet AQL 2.5. This seems to be a specific sample size.
   • Biocompatibility (Primary Skin Irritation, Dermal Sensitization): The sample size for these studies is not specified in the provided summary.
   • Tensile Strength and Ultimate Elongation (Before and After Aging): The specific sample size used for these mechanical properties tests is not explicitly stated.
   • Water Fill Test: "Samplings of AOL 2.5, Inspection Level I" was used, but the specific number of gloves isn't given.
   • Data Provenance: The data appears to be prospective testing conducted on the Yongsheng Medical Products Co., Ltd gloves. The "country of origin" for these tests is implicitly China, as the submitter is based in China.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an examination glove, and its performance is evaluated through objective physical, chemical, and biological tests governed by established standards (e.g., ASTM). There is no mention of human expert interpretation or subjective ground truth establishment for these types of tests.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as expert adjudication is not relevant for the objective performance tests of an examination glove.

4. 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 document pertains to a physical medical device (examination gloves), not an AI imaging or diagnostic algorithm.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm. The tests are for the physical properties of the glove.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the performance characteristics of the gloves is established by the methods, specifications, and acceptable limits defined in the referenced industry standards, primarily ASTM D5250-06 for general requirements, ASTM D6124-06 for residual powder, and ASTM D5151-06 for pinhole defects. Biocompatibility tests followed standard protocols to determine irritation and sensitization.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

8. 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 fingers to prevent contamination between patient and examiner.

A Powder-free Clear Vinyl Patient Examination Gloves 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). Our Powder-free Clear Vinyl Patient Examination Gloves do not contain any UPS powder according to the results of testing conducted on the gloves. The residual powder testing is conducted per standards of ASTM D-6124-06, which demonstrates that the powder free glove is less than 2mg/pc. 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 requirement of ASTM Standard D5250-06.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Test Set Sample Sizes:
     • Pinhole Results: 125 gloves.
     • Residual Powder: Not explicitly stated but testing performed "per standards of ASTM D-6124-06" which would imply a specific sampling plan.
     • Tensile Strength & Elongation (Before & After Aging): Not explicitly stated, but implies a sample of gloves tested according to ASTM-D-5250-06.
     • Biocompatibility (Primary Skin Irritation & Dermal Sensitization): A study was conducted, but the number of subjects or samples is not specified.
     • Physical and Dimensions Testing: Inspection Level S-2, AQL 2.5.
     • FDA 1000 ml. Water Fill Test: Samplings of AQL 2.5, Inspection Level I.
   • Data Provenance: The document implies the testing was conducted by or on behalf of Shandong Zhiwei Medical Products Co., Ltd., based in China, for regulatory submission to the FDA. The nature (retrospective/prospective) of these specific tests is not stated, but they are typically prospective functional and safety tests performed on representative samples of the manufactured device.

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

   • This submission is for a patient examination glove, a relatively simple medical device. The "ground truth" for the performance characteristics (e.g., tensile strength, pinholes, residual powder, biocompatibility) is established through standardized laboratory testing protocols (e.g., ASTM standards) rather than expert consensus on medical images or clinical outcomes.
   • Therefore, the concept of "experts" to establish a ground truth in the way it applies to diagnostic AI devices (e.g., radiologists interpreting images) is not directly applicable here. The "experts" would be the qualified laboratory personnel conducting the tests according to the specified ASTM and FDA protocols, ensuring adherence to the methodology. Their specific number and qualifications (e.g., years of experience in materials testing, chemistry, or toxicology) are not detailed in this summary.

4. Adjudication method for the test set:

   • Adjudication methods like "2+1" or "3+1" are typically used in studies involving human interpretation (e.g., radiologists, pathologists) where disagreements need to be resolved.
   • For the laboratory-based performance and safety testing of this medical device, adjudication in this sense is not directly applicable. The "adjudication" is inherent in the adherence to standardized testing methods (e.g., ASTM standards), where objective measurements are taken, and results are compared against predefined acceptance criteria. Any deviations or borderline results would typically lead to re-testing or investigation according to quality control procedures.

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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) are assisted by AI. This device is a physical patient examination glove and does not involve human interpretation or AI assistance in the same context.

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

   • No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm or software. The performance evaluations are based on the intrinsic physical, chemical, and biological properties of the glove itself.

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

   • The "ground truth" for this device's performance is based on objective measurements and standardized test results against established industry and regulatory standards.
     • Physical Properties: Measured values for tensile strength, elongation, length, width, and thickness are the ground truth, compared against "similar" performance of predicate devices and ASTM D5250-06 requirements.
     • Pinhole Detection: The quantifiable count of pinholes in a sample is the ground truth, compared against an AQL of 2.5 (ASTM D5151-06) and the FDA 1000 ml. Water Fill Test.
     • Residual Powder: The measured weight of residual powder is the ground truth, compared against the <2 mg/glove criterion of ASTM D6124-06.
     • Biocompatibility: The observed biological response in irritation and sensitization tests (e.g., "not an irritant," "not a sensitizer") serves as the ground truth, assessed under specific study conditions.

8. The sample size for the training set:

   • This document describes the premarket notification (510(k)) for a physical medical device (patient examination gloves). It does not involve machine learning or AI, and therefore, there is no "training set" in the context of algorithm development. The gloves are manufactured, and samples from production lots are tested to ensure quality and demonstrate substantial equivalence.

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

   • As there is no AI/ML involved and thus no "training set," this question is not applicable. The "ground truth" for the device's performance is established through adherence to the testing methodologies themselves as described in item 7.

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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.

Subject device: Powder Free Clear Vinyl Patient Examination Glove Color: Clear Overall Length: 230mm min Width: 94mm min Palm Thickness: 0.09 mm min Fingertip Thickness: 0.086 mm min

The provided document describes the acceptance criteria and performance of the Powder-Free Clear Vinyl Patient Examination Gloves by Zibo Yue Fan Medical Products Co., Ltd. against a predicate device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are defined by compliance with ASTM standards and key physical properties. The "reported device performance" reflects the measured values for the subject device and the predicate device.

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

• Test Set Sample Size:
  • For Pinhole Results: 125 pieces of gloves.
  • For other physical and performance characteristics, the document states "Inspection Level S-2, AOL 2.5," which refers to sampling plans defined in standards like ASTM D-5250-06 or ISO 2859-1. The exact number of samples tested for each characteristic is not explicitly stated as a single number but is determined by the AQL (Acceptance Quality Limit) and inspection level.
• Data Provenance: Not explicitly stated, but based on the manufacturer's location (Zibo, Shandong, China) and the testing standards used (ASTM), the testing would likely have been conducted in China or by a laboratory accredited to perform these tests for a Chinese manufacturer. The data appears to be prospective as it is generated for the purpose of a 510(k) submission.

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 to this type of device. The "ground truth" for patient examination gloves is established through objective, standardized physical and chemical tests (e.g., tensile strength, elongation, pinhole detection, residual powder) according to recognized ASTM standards, rather than through expert consensus on qualitative assessments.

4. Adjudication method for the test set

Not applicable. As noted above, the "truth" is determined by objective measurement against established physical and chemical standards, not by human interpretation or 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

Not applicable. This device is a patient examination glove and does not involve AI or human "readers" in its function or evaluation.

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

Not applicable. This device is a physical medical product, not an algorithm or software.

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

The ground truth used for this device is based on objective, quantitative measurements obtained through standardized physical and chemical testing methods, as defined by ASTM (American Society for Testing and Materials) standards. This includes:

• ASTM D-5250-06 for physical and dimensional testing (e.g., length, width, thickness, tensile strength, elongation).
• ASTM D-6124-06 for residual powder content.
• ASTM D-5151-06 for pinhole detection.
• Biocompatibility tests (primary skin irritation and dermal sensitization) performed under controlled conditions.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.

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

Not applicable. As there is no training set for this type of device, no ground truth was established for it.

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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.

The subject device is Powder-Free Vinyl Patient Examination Gloves that is worn upon the examiner's hands or finger. As a barrier, the subject device prevents contamination between patient and examiner. The subject device meets all of the requirements of ASTM standards D5250-06 for Physical and performance characteristics, D5151-06 for barrier properties and D6124-06 for residual powder.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder-Free Clear Vinyl Patient Examination Gloves (K142892).

It's important to note that this document is a 510(k) summary for a Class I medical device (patient examination glove). For such devices, the FDA typically relies on performance standards and substantial equivalence to a predicate device rather than extensive clinical trials for approval.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: The document specifies that "The dimensions and physical properties tests followed ASTM D5250-06 and met AQL 2.5, inspection level S-2." and "The barrier test followed ASTM D5151-06 and met AQL 2.5, inspection level S-1." These AQL (Acceptable Quality Limit) levels refer to a sampling plan for inspection.
     • For physical properties (ASTM D5250-06) with AQL 2.5, inspection level S-2, the sample size would be determined by the specific batch size being tested according to the ASTM standard. For example, for a batch size of 50,001 to 150,000, inspection level S-2 uses a sample size of 80.
     • For barrier test (ASTM D5151-06) with AQL 2.5, inspection level S-1, the sample size would also be determined by the batch size. For a batch size of 50,001 to 150,000, inspection level S-1 uses a sample size of 50.
   • Data Provenance: The tests were conducted internally by the manufacturer or a contracted lab. The document does not specify the country of origin of the data beyond the manufacturer being in China. The tests are prospective in nature, as they are performed on the newly manufactured device to ensure it meets the specified standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is Not Applicable in the context of this device and study type. The "ground truth" for these tests are objective, measurable physical, chemical, and biological properties evaluated against established industry standards (ASTM, ISO). There is no "expert consensus" on classifications or interpretations of images, for example. The tests are performed by technicians following standard protocols.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is Not Applicable. The tests performed are objective measurements against defined pass/fail criteria from the ASTM and ISO standards. There is no subjective interpretation requiring adjudication among experts.

4. 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: This is Not Applicable. This document is for a medical glove, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is Not Applicable. This is a physical medical device, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests is based on objective measurements against established industry standards.

   • For physical properties (tensile strength, elongation, dimensions), the ground truth is the values obtained from standardized mechanical tests.
   • For barrier properties (pinholes), the ground truth is the number of defects found in a sample based on a standardized liquid integrity test.
   • For residual powder, the ground truth is the measured mass of powder per glove.
   • For biocompatibility (irritation, sensitization), the ground truth is the observable biological response in a standardized animal or in-vitro test model, assessed against predefined criteria for irritation/sensitization.

7. The sample size for the training set: This is Not Applicable. As this is not an AI/machine learning device, there is no "training set." The device is manufactured and tested against pre-defined specifications.

8. How the ground truth for the training set was established: This is Not Applicable for the reasons stated above.

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