Search Results

The POWDER FREE patient examination gloves 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 vinyl examination glove made of synthetic poly vinyl chloride compound. It is sterile, POWDER FREE. The device is ambidextrous. The device meets ASTM D 5250-06: Standard specification for poly vinyl chloride gloves for medical application. The device is for over-the counter single use.

The provided document is a 510(k) premarket notification for Sterile Vinyl Examination Gloves, Powder Free by Primus Gloves, Pvt. Limited (K170612). This document is a regulatory submission for a Class I medical device, which typically does not involve studies for AI performance or clinical efficacy comparison in the way a diagnostic imaging device would. Instead, the "acceptance criteria" and "study" refer to demonstrated conformance with established industrial standards for medical gloves and substantial equivalence to a predicate device.

Let's break down the information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by various ASTM and ISO standards for examination gloves. The reported device performance indicates that the "Sterile Vinyl examination gloves, POWDER FREE" meet these specified standards.

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

The document indicates sampling plans based on ISO 2859-1 for various tests (e.g., G1/AQL 2.5 for freedom from holes, S2/AQL 4.0 for dimensions and physical properties). For Powder Free residue, N=5 is stated.

• Sample Size:
  • For physical characteristics (Freedom from Holes, Dimensions, Physical Properties): Specific sample sizes are not explicitly given as absolute numbers, but the reference to ISO 2859-1 with specified Inspection Levels (G1, S2) and AQLs (2.5, 4.0) implies a statistical sampling methodology based on lot size.
  • For Powder Free residue: N=5 gloves.
  • For biocompatibility: The ISO 10993-10 standards would specify animal testing protocols (e.g., rabbits for irritation, guinea pigs for sensitization), but the exact number of animals or repeat tests is not provided in this summary.
• Data Provenance: Not explicitly stated for each test result, but the manufacturing company is PRIMUS GLOVES PRIVATE LIMITED located in Cochin, Kerala, India. It can be inferred that the testing data was generated locally or through contract labs testing products manufactured at this site. The studies are retrospective in the sense that they are tests performed on manufactured batches to confirm compliance with standards.

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

This type of device (examination gloves) does not typically involve human expert consensus for "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is defined by adherence to objective, measurable physical, chemical, and biological properties as specified in the referenced ASTM and ISO standards.

• Number of Experts: Not applicable in the context of expert consensus for AI ground truth. The "experts" in this scenario are the technical committees and bodies that establish the ASTM and ISO standards, and the qualified laboratory personnel who conduct the standardized tests.
• Qualifications of Experts: N/A for clinical expert consensus. The "experts" are the technicians and engineers performing standardized tests in accredited laboratories.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI diagnostic device requiring adjudication of interpretations. The tests are objective measurements against established thresholds.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, this is not an AI device or a diagnostic device that would typically undergo an MRMC study.

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

No, this is a physical medical device (examination gloves), not an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on objective, measurable criteria defined by international and national standards and specifications (e.g., ASTM D 5250-06, ASTM D5151-06, ISO 10993-10, ISO 11737-02). These standards define acceptable ranges for physical dimensions, mechanical properties, chemical residue, and biological responses (biocompatibility).

8. The Sample Size for the Training Set

Not applicable. This is a manufactured product, not an AI model that requires a training set. The "training" for such a product would involve process validation and quality control measures during manufacturing, but not a dataset as understood in AI/ML.

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

Not applicable, as there is no "training set" in the context of an AI device. The manufacturing processes are validated to consistently produce gloves that meet the defined standards.

Ask a specific question about this device

The powder-free Nitrile Surgical Gloves, is a sterile and single use devise made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.

The subject device is a surgical nitrile qlove made of synthetic nitrile latex compound. It is sterile, powder-free. The device is anatomic. The device meets ASTM D 3577-09: Standard specification for Rubber Surgical gloves for Medical Application. The device is for over-the counter single use.

This document describes the performance data and acceptance criteria for the "Sterile Nitrile Surgical Gloves, Powder-free" manufactured by Primus Gloves Pvt. Limited (K170515).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "Sampling plan/Inspection level/AQL" for some tests:

• Freedom from Pinholes: G1/AQL 2.5 (per ISO 2859-1)
• Dimensions: S2/AQL 4.0 (per ISO 2859-1)
• Physical properties (Before and After aging): S2/AQL 4.0 (per ISO 2859-1)
• Powder-free residue: N=5

The specific total sample sizes (number of gloves tested) for each characteristic are not explicitly stated as a single number but are derived from the specified AQL (Acceptance Quality Limit) and inspection levels per ISO 2859-1.

Data Provenance: The document does not explicitly state the country of origin of the test data (e.g., where the testing labs are located) or whether the data is retrospective or prospective.

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

Not applicable. This document describes the testing of a medical device (surgical gloves) against recognized consensus standards (ASTM, ISO, FDA). The "ground truth" for these tests are the objective measurements and pass/fail criteria defined by these standards, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

Not applicable. The tests performed are objective measurements (e.g., dimensions, tensile strength, leak test) against defined numerical or qualitative standards. There is no mention of, nor a need for, human adjudication for these types of tests.

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 or AI-assisted interpretation devices to assess the impact on human reader performance. The device here is a physical product (surgical gloves).

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

Yes, the studies conducted are standalone performance studies of the device itself, without human-in-the-loop performance. The various physical, chemical, and biological tests assess the inherent properties and performance of the glove.

7. The Type of Ground Truth Used:

The "ground truth" used for these studies is based on:

• Consensus Standards: Specifically ASTM D 3577-09, ASTM D412-06, ASTM D5151-06 (reap 2011), ASTM D6124-06, ISO 2859-1, ISO 10993-10, and ISO 11737-02.
• Defined Pass/Fail Criteria: Each test has numerical or qualitative criteria for what constitutes a "PASS" (e.g., tensile strength > 17 Mpa, less than 2 mg powder per glove, not an irritant).

8. The Sample Size for the Training Set:

Not applicable. This device is a physical product (surgical gloves) and does not involve AI/machine learning algorithms that require a "training set" in the context of image analysis or diagnostic models. The manufacturing process itself (which is optimized over time) could be considered a form of "training," but not in the data science sense.

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

Not applicable, as there is no "training set" in the context of AI/ML for this device. The quality control and manufacturing processes ensure the product consistently meets the established standards.

Ask a specific question about this device

The Nitrile Patient Examination gloves. Powderfree. 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 non-sterile, powderfree and is Blue in color. The device is ambidextrous and can be worn on either the left or right hand. The device meets ASTM 06319-10: 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 is a 510(k) premarket notification for Nitrile Patient Examination gloves. It does not describe an AI/ML medical device. Therefore, it is not possible to extract information related to AI/ML device acceptance criteria or studies proving device performance, as the requested fields (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment, training set size) are not applicable to this type of medical device submission.

The document focuses on demonstrating substantial equivalence to a predicate device (K121947) through performance data based on established ASTM standards and biocompatibility tests for examination gloves.

Here's the relevant information that directly addresses the "acceptance criteria and the study that proves the device meets the acceptance criteria" for this non-AI/ML medical device:

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

The document provides a detailed table comparing the subject device (Nitrile Patient Examination gloves, Powderfree, Blue color) to a legally marketed predicate device (ETS Blue Powderfree Nitrile patient exam glove, K121947) across various characteristics. The "Acceptance criteria/Standard" column outlines the benchmarks, typically ASTM standards or FDA guidance. The "SUBJECT DEVICE : K143477" column indicates the subject device's performance against these criteria, consistently stating "PASS" or meeting the specified physical properties.

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

The document refers to sampling plans and inspection levels for certain tests:

• Freedom from Pin holes: ISO 2859-1 / G11 AQL 2.5
• Dimensions: ISO 2859-1 / S2 AQL 4.0
• Physical Properties (Before and After aging): ISO 2859-1 / S2 AQL 4.0
• Powder-free residue: N=5 gloves

The exact numerical sample sizes for each test are not explicitly stated as absolute numbers but rather by the sampling plans (e.g., ISO 2859-1). The data provenance is not explicitly mentioned as "country of origin" for the test data, nor is it categorized as "retrospective or prospective." However, given the nature of the device (examination gloves) and the standards used, it's implied that these are laboratory tests performed on samples of the manufactured gloves.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a non-AI/ML medical device submitting for 510(k) clearance. The "ground truth" for the physical and chemical properties of the gloves is established through adherence to defined ASTM and ISO standards and laboratory testing protocols, not by expert consensus or interpretations in a diagnostic sense.

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

Not applicable, as this is not an AI/ML device involving human interpretation that would require an adjudication method.

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 non-AI/ML medical device.

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

Not applicable. This is a non-AI/ML medical device.

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

The "ground truth" for this device's performance is based on established industry standards and validated laboratory test methods. This includes:

• ASTM International Standards: Such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D412-06 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension), ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves), and ASTM D7160-05 (Standard Practice for Determination of Expiration Dating for Medical Gloves).
• ISO Standards: Specifically ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization) for biocompatibility.
• FDA water leak test (1000ml).

8. The sample size for the training set:

Not applicable. This is a non-AI/ML medical device; therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established:
Not applicable. There is no training set for this non-AI/ML medical device.

Ask a specific question about this device