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The Sterile Latex Surgical Gloves, Powder free, is a disposable device made of natural rubber; intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.

The subject device is a surgical glove made of natural rubber latex compound. It is sterile, Powder free. The device is anatomic and is hand specific. The device meets ASTM D3577 – 09 : Standard specification for Rubber Surgical Gloves. The device is for over-the counter single use.

The provided document is a 510(k) premarket notification for Sterile Latex Surgical Gloves, Powderfree. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or performance for an AI/ML-based device.

Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document primarily addresses the following for medical devices like surgical gloves:

• Acceptance Criteria & Device Performance: This section is presented as a comparison table against the predicate device and relevant ASTM/ISO standards.
• Non-Clinical Testing: The study proves the device meets acceptance criteria through various standardized tests.

Here's the relevant information extracted from the document concerning the acceptance criteria and the study proving the device meets them:

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

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

• Sample Sizes: Sample sizes are indicated within the "Sampling plan / Inspection level / AQL" columns in the performance data table (e.g., ISO 2859-1 / G1 / AQL 2.5, ISO 2859-1 / S2 / AQL 4.0, N=5 for powder-free residue). For the specific Freedom from Pinholes test, it notes: "Lot Size : 35001 – 150000 pair; Sample size : 200 pair".
• Data Provenance: Not explicitly stated as "country of origin" or "retrospective/prospective" in the context of clinical studies, as this is laboratory/manufacturing performance data. The manufacturer is SANREA HEALTHCARE PRODUCTS PVT LTD, located in Palakkad, Kerala, India.

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

• Not Applicable: This type of testing involves laboratory and physical property measurements against established international standards (ASTM, ISO, FDA). "Ground truth" in this context is defined by the technical specifications and methodologies of these standards, not expert adjudication of medical images or clinical outcomes.

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

• Not Applicable: As above, this pertains to physical and chemical testing against defined standard metrics.

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 a premarket notification for a Class I medical device (surgical gloves), not an AI/ML-based diagnostic or assistive technology.

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

• Not Applicable: This is not an AI/ML algorithm.

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

• Standardized Test Methods and Specifications: The "ground truth" for the performance of these gloves is defined by the requirements and test methodologies outlined in the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM D3577-09 for rubber surgical gloves, ASTM D5151-06 for freedom from holes, ISO 10993 for biocompatibility, ISO 11135 for sterilization). The FDA 1000ml water leak test is also mentioned.

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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The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

The subject device is a patient examination glove made of latex compound. It is sterile, Powder Free. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D3578-05: Standard specification for Rubber Examination Gloves. The subject device is substantially equivalent to legally marketed Latex Examination Powder Free gloves identified as Product code LYY. The device is for over-the counter single use.

The provided document is a 510(k) premarket notification for a medical device: SANCARE STERILE LATEX EXAMINATION GLOVES.

It describes the device's characteristics and compares its performance against a legally marketed predicate device (K052728, Powder free Latex Sterile Patient Examination Gloves from M/S. KANAM LATEX INDUSTRIES PVT. LTD.) to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SANCARE STERILE LATEX EXAMINATION GLOVES are primarily based on established ASTM standards and FDA water leak tests, as compared to the performance of the predicate device. The document explicitly states that the device "Meets" all specified standards.

2. Sample Sizes Used for Test Set and Data Provenance

Specific sample sizes for each test are provided within the table under "Sampling plan / Inspection level / AQL":

• Freedom from Pinholes: ISO 2859-1 / G1 / AQL 2.5
• Dimensions (Length, Width, Thickness): ISO 2859-1 / S2 / AQL 4.0 for each
• Physical Properties (Before & After aging): ISO 2859-1 / S2 / AQL 4.0 for each
• Powder-free residue: N=5
• Residual Protein: N=3

The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission for a finished medical device (gloves), the performance data would typically be generated by the manufacturer through in-house testing or contracted labs, following international standards (ASTM, ISO).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and submission. This is a submission for examination gloves, which are evaluated based on physical, chemical, and biological performance characteristics against recognized standards, not clinical diagnostic accuracy requiring expert interpretation of images or patient data.

4. Adjudication Method for the Test Set

This information is not applicable. The device's performance is determined by objective laboratory tests against pre-defined thresholds from standards, not through adjudication of expert opinions.

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., AI algorithms for medical imaging) that involve human readers' interpretation of outputs. For examination gloves, the evaluation criteria are entirely different, focusing on physical properties, safety, and sterility.

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

No, a standalone "algorithm only" study was not done. This concept is specific to AI or software as a medical device (SaMD). The SANCARE STERILE LATEX EXAMINATION GLOVES are a physical, Class I medical device. The performance data presented (e.g., tensile strength, freedom from holes) are inherent characteristics of the gloves themselves, independent of any algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on established international performance standards (ASTM D3578-05, ASTM D5151-06, ASTM D412-06, ASTM D6124-06, ASTM D5712-15, ISO 10993-10, ASTM D7160-05, ISO 11135-2014(E), ISO 11737-2) and FDA-specific tests (FDA 1000ml water leak test). These standards define acceptable ranges or conditions for physical properties, biocompatibility, and sterility.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of examination gloves. This term typically refers to data used to train machine learning models, which are not involved in the manufacturing or evaluation of this device.

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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The Sterile Nitrile Patient Examination gloves, Powder free, Blue color, is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.

The subject device is a patient examination glove made of synthetic nitrile latex compound. It is sterile, Powder free and is Blue in colour. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM D6319-10: Standard specification for Nitrile Examination Gloves for Medical Application. The subject device is substantially equivalent to legally marketed Nitrile examination gloves identified as Product code LZA. The device is for over-the counter single use.

The provided document describes the Sanrea Healthcare Products Pvt Ltd's Sterile Nitrile Patient Examination Gloves, Powder free, Blue color, and its equivalence to a predicate device. The information details the performance testing and acceptance criteria for this Class I medical device.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Physical Properties and Freedom from Holes: The sample sizes are generally cited within the "Sampling plan / Inspection level / AQL" column. For example, for "Freedom from Holes," it refers to "ISO 2859-1 / G1/AQL 2.5." For "Dimensions" and "Physical Properties," it refers to "ISO 2859-1 / S2/AQL 4.0." For "Powder-free residue," N=5 is used. The specific number of gloves tested within these AQL standards is not explicitly stated as a single number but is dictated by the standard.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is SANREA HEALTHCARE PRODUCTS PVT LTD, located in Palakkad, Kerala, India. It can be inferred that the testing was conducted either internally by the manufacturer or by a third-party laboratory, likely in India, to demonstrate compliance with the cited ASTM and ISO standards.

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

This section is not applicable to this type of device (patient examination gloves). The "ground truth" for these tests is established by objective physical, chemical, and biological measurements performed according to recognized international standards (ASTM, ISO). There is no interpretation by human experts required to establish a diagnostic ground truth, unlike with image-based AI devices.

4. Adjudication method for the test set

This is not applicable as the tests are objective measurements against defined physical, chemical, and biological criteria, not subjective interpretations requiring 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

This is not applicable. This document describes a medical device (examination gloves) that does not incorporate AI or involve human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.

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

This is not applicable. The device is an inanimate object (nitrile gloves) and does not involve any algorithms.

7. The type of ground truth used

The "ground truth" for the performance claims of these gloves is based on:

• Standardized Physical Measurements: Length, width, thickness, tensile strength, ultimate elongation performed according to ASTM D6319-10 and ASTM D412-06.
• Standardized Chemical Measurements: Powder-free residue performed according to ASTM D6124-06.
• Standardized Biological Testing: Biocompatibility (primary skin irritation and skin sensitization) performed according to ISO 10993-10, and sterility testing according to ISO 11737-2.
• Performance Tests: Freedom from holes measured by FDA 1000 ml water leak test and ASTM D5151-06.

8. The sample size for the training set

This is not applicable. There is no "training set" for this type of medical device as it does not involve machine learning or AI algorithms. The performance is assessed through direct physical, chemical, and biological testing of manufactured samples.

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

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

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