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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:

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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.

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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

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