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Examination glove (Nitrile) is a disposable device made of Nitrile Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all 'the requirements of ASTM D3578- 95.

This document describes the performance and acceptance criteria for Shiva Medicare Limited's Powdered Nitrile Examination Gloves.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes used for each specific test (e.g., length, width, tensile strength). It refers to the "performance test data" but doesn't detail the sampling plan.

The data provenance is:

• Country of Origin: India (Shiva Medicare Limited is located in Chennai, India).
• Retrospective or Prospective: Not explicitly stated, but the tests were conducted on gloves manufactured by Shiva Medicare Limited to demonstrate compliance with ASTM D3578-95, suggesting these were contemporary tests on their product.

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

Not applicable. This is a technical performance study of a physical device (gloves), not a diagnostic device requiring expert interpretation of images or clinical data. The "ground truth" is defined by the objective measurement standards outlined in ASTM D3578-95.

4. Adjudication Method for the Test Set:

Not applicable, as this is a physical device performance study. The evaluation is based on direct measurement and adherence to the specified ASTM standard.

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-powered diagnostic device, but a medical glove.

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

Not applicable. This is not an AI-powered device. The device itself (the glove) is what's being evaluated, and its performance is measured directly against technical specifications.

7. The Type of Ground Truth Used:

The ground truth used is objective measurement against established industrial standards, specifically ASTM D3578-95 for examination gloves. These standards define the acceptable ranges for physical properties like dimensions, tensile strength, elongation, and freedom from holes. For Powder, Protein, and Moisture content, specific SML values are provided with no direct ASTM D3578 comparative requirement stated in the table, implying these are internal specifications or generally accepted values. Biocompatibility is stated as "Biologically Compatible" without further detail on the specific tests or standards used, though it implies compliance with relevant biocompatibility testing.

8. The Sample Size for the Training Set:

Not applicable. This is a physical device and does not involve AI or machine learning models that require training data.

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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Nitrile Examination Gloves Powder free is a powder free disposable device made of Nitrile Latex intended for medical purpose, that is worn on the examiners hand or finger to prevent contamination between patient and Examiner.

Class I Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.

The provided documents describe a 510(k) submission for Nitrile Examination Gloves (Powder-free) manufactured by Shiva Medicare Limited, seeking to demonstrate substantial equivalence to a predicate device. This submission is for a Class I medical device, which typically does not involve complex AI algorithms or extensive clinical studies in the same way higher-risk devices might.

Based on the provided information, the acceptance criteria and study proving the device meets these criteria are focused on physical characteristics and performance of the examination gloves, aligning with ASTM D3578-95 standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the specific number of gloves tested for each characteristic. It refers to "Measured Parameters" and "Performance Data" but does not detail the statistical sampling plan (e.g., how many gloves from how many batches were tested). The AQL (Acceptable Quality Level) values (S4, S2) mentioned imply a standardized sampling plan used for quality control, but the exact sample sizes are not provided within this document.
• Data Provenance: The data is generated by the manufacturer, Shiva Medicare Limited, in India ("A 15, 16, 17(PART) MADRAS EXPORT PROCESSINGZONE KADAPERI, TAMBARAM, CHENNAI 600 045. INDIA."). The nature of the tests (physical and chemical properties) indicates that the data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this 510(k) submission.

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

This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective, measurable physical and chemical properties as defined by international standards (ASTM D3578-95). There is no "expert consensus" required for dimensions, tensile strength, or elongation at break; these are determined by laboratory measurements.

4. Adjudication Method for the Test Set:

This is not applicable. As stated above, the device performance is measured against objective, predetermined standards (ASTM D3578-95). There is no "adjudication" process in the sense of multiple human experts reviewing and deciding on a finding. The measurements either meet the specification or they don't.

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

No. This is a physical product (examination gloves), not an AI-powered diagnostic device or an imaging product that would involve human readers interpreting cases. Therefore, an MRMC study is not relevant.

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

No. This device is an examination glove, a physical product, not an algorithm or software. Therefore, standalone performance evaluation of an algorithm is not applicable.

7. The Type of Ground Truth Used:

The ground truth used is objective, measurable physical and chemical properties as defined by the ASTM D3578-95 international standard for rubber examination gloves. This standard sets the quantitative requirements for these properties.

8. The Sample Size for the Training Set:

Not applicable. This dossier describes a traditional medical device (gloves), not an AI/ML-based device. There is no "training set" in the context of machine learning. The "training" in manufacturing refers to process control and quality system implementation.

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

Not applicable. As there is no AI/ML component, there is no "training set" or "ground truth for the training set" as defined in the context of AI. The product is manufactured and tested according to established quality control procedures against predefined standards.

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Surgeon's glove is a medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.

Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder that meets all 'the requirements of ASTM D3577.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Device: Surgeon's Glove (Latex, Powdered with Absorbable Dusting Powder) manufactured by Shiva Medicare Limited.

1. Table of Acceptance Criteria and Reported Device Performance:

The document presents two main sets of criteria: Technological Characteristics and Performance Requirements.

Conclusion of Performance Test Data: The document explicitly states:

• "The Surgeon's gloves manufactured by Shiva Medicare Limited"
• "Meet or exceed the ASTM D3577"
• "Meet FDA Pin hole Requirement."
• "Meet labelling claim as shown by the data in 6 -" (presumably referring to section 6.0, intended use).

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

The document does not explicitly state the specific sample sizes used for each test (length, width, tensile strength, etc.). It provides 'values' for characteristics and 'levels followed' (e.g., S4, S2) for performance requirements, which are typically associated with sampling plans (e.g., ISO 2859). However, the exact number of units tested for any given parameter is not provided.

The data provenance is retrospective, as it refers to performance data obtained from manufacturing processes already completed by Shiva Medicare Limited. The origin of the data is India (Chennai, specifically, where Shiva Medicare Limited is located).

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

Not applicable. This device is a medical glove, not a diagnostic or AI-driven device requiring expert adjudication for ground truth. The "ground truth" here is defined by the objective physical and chemical properties and performance standards outlined in ASTM D3577 and FDA requirements.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is not an AI or diagnostic study requiring expert adjudication. The assessment is based on direct measurement and comparison to 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 relevant for diagnostic devices (e.g., medical imaging AI) where human readers interpret cases, and the AI's impact on their performance is measured. This document pertains to a physical medical device (surgical gloves).

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

Not applicable. There is no algorithm or AI component in this device.

7. The Type of Ground Truth Used:

The ground truth used is based on International Standards and Regulatory Requirements. Specifically:

• ASTM D3577: Standard specification for rubber surgical gloves. This provides the objective, measurable criteria for physical dimensions and mechanical properties.
• USP (United States Pharmacopeia) / IP (Indian Pharmacopeia): For sterility requirements.
• FDA Requirements: For aspects like pinhole (freedom from holes), protein content, moisture content, and biocompatibility.

8. The Sample Size for the Training Set:

Not applicable. There is no AI model, and thus no "training set" for this device. The data presented are from product testing and quality control processes.

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

Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by consensus standards organizations (like ASTM) and regulatory bodies (like FDA), which define the required physical, chemical, and performance attributes for the product.

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Latex examination glove (Powder free) is a Powder free device intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Class I Patient Examination Gloves Latex ( Powder free) 80LYY that meets all 'the requirements of ASTM D3578- 95.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Shiva Medicare Limited Latex Examination Gloves (Powder free):

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance: The Shiva Medicare Limited Latex Examination Gloves (Powder free) meet or exceed all the specified acceptance criteria from ASTM D3578-95 and FDA pinhole requirements, as reported in the Conclusion of Performance Test Data.

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

• Sample Size: Not explicitly stated. The document refers to "Performance test data of the powder free examination glove manufactured by Shiva Medicare Limited" but does not detail the number of units tested for each characteristic. It mentions AQL (Acceptance Quality Limit) levels (S4, S2) which implies a sampling plan, but the specific sample sizes used per test are not provided.
• Data Provenance: The data is generated by Shiva Medicare Limited, located in India (Madras Export Processing Zone, Chennai). The data is prospective as it's presented as the performance of the manufactured device tested against established standards.

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

• Not Applicable. This study is a performance test of a medical device against established industry standards (ASTM D3578-95) and regulatory requirements (FDA pinhole requirement). Ground truth here is defined by these pre-existing technical specifications, not by expert consensus on individual "cases" or "images."
• There were no "experts" establishing a case-by-case ground truth in the traditional sense of a diagnostic study. The "ground truth" is the published standard.

4. Adjudication method for the test set

• Not Applicable. As explained above, this is a product performance test against predefined technical standards. There is no adjudication of findings between multiple reviewers as would be seen in clinical image interpretation studies. The measurements are objective physical properties.

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. This is a performance study for a physical medical device (gloves), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.

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

• No. This is a performance study for a physical medical device (gloves), not an algorithm. This concept does not apply.

7. The type of ground truth used

• The ground truth used is a combination of:
  • Expert Consensus/Standard: The established international standard ASTM D3578-95 for Latex Examination Gloves. ASTM standards are developed through a consensus process involving experts in the field.
  • Regulatory Requirement: "FDA Pinhole Requirement."

8. The sample size for the training set

• Not Applicable. This is a performance study for a physical medical device (gloves), not a machine learning model. Therefore, there is no "training set" in this context. The product is manufactured and then tested to ensure it meets specifications.

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

• Not Applicable. As there is no training set for a machine learning model, this question does not apply.

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Powder free Surgeon's glove is a sterile powder free medical device intended to be worn I oncer free bargen ersonnel to protect a surgical wound from contamination.

Class I Powder free Surgical Glove 79KGO that meets all the requirements of ASTM D3577.

Here's a summary of the acceptance criteria and the study for the Shiva Medicare Limited Powder-Free Surgeon's Glove, as derived from the provided document:

This document describes the performance of a medical device, specifically a "Powder free Surgeon's Glove" manufactured by Shiva Medicare Limited, and its adherence to the ASTM D3577 standard. The primary goal of the submission appears to be demonstrating substantial equivalence to a legally marketed predicate device (Class I Surgeon's Glove (Powder free) 79KGO that meets all the requirements of ASTM D3577).

1. Table of Acceptance Criteria and Reported Device Performance:

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