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The Ultra Preserve With Aloe Vera (Green) Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D3578-00 and ASTM D5151-99 requirements.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Ultra Preserve With Aloe Vera (Green) Natural Rubber Latex Examination Glove:

Summary on Acceptance Criteria and Supporting Studies

This 510(k) submission primarily relies on performance testing against established ASTM standards and comparison to legally marketed predicate devices to demonstrate substantial equivalence. It does not involve a study with human readers or AI, as it is for a medical device (examination glove) where performance is evaluated through material properties and barrier integrity rather than diagnostic interpretation.

1. Table of Acceptance Criteria and Reported Device Performance

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The Sensi Grip® Surgical Glove is a disposable device intended for medical use within hospitals and other healthcare facilities during invasive and non-invasive medical procedures requiring sterility. They are intended to be worn on the operating room personnel's hand to protect a surgical wound from contamination.

Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The latex rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching and washing process removes traces of chemical accelerants That may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D3577-00 and ASTM D5151-99 requirements.

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Non-Clinical Tests": {
      "SPECIFICATION": [
        "PERFORMANCE STANDARDS",
        "WATER TIGHTNESS",
        "RESIDUAL PROTEIN"
      ],
      "ACCEPTANCE CRITERIA (Proposed Powdered Glove)": [
        "ASTM D3577-00: Meets or Exceeds Requirements",
        "ASTM D5151-99: Meets or Exceeds Requirements",
        "ASTM D5712-99: Meets or Exceeds Requirements"
      ],
      "REPORTED DEVICE PERFORMANCE (Proposed Powdered Glove)": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ],
      "PREDICATE DEVICE PERFORMANCE": [
        "ASTM D3577-91: Meets or Exceeds Requirements",
        "ASTM D5151-92: Meets or Exceeds Requirements",
        "Not applicable (predicate did not have a protein labeling claim)"
      ]
    },
    "Clinical Tests": {
      "SPECIFICATION": [
        "SAFETY: SKIN IRRITATION",
        "SKIN SENSITIZATION"
      ],
      "ACCEPTANCE CRITERIA (Proposed Powdered Glove)": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ],
      "REPORTED DEVICE PERFORMANCE (Proposed Powdered Glove)": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ],
      "PREDICATE DEVICE PERFORMANCE": [
        "Meets or Exceeds Requirements",
        "Meets or Exceeds Requirements"
      ]
    }
  },
  "2. Sample sized used for the test set and the data provenance": "The document does not explicitly state the sample sizes used for the non-clinical and clinical tests. It only refers to meeting or exceeding ASTM standards and general safety requirements. The data provenance is implied to be from tests conducted by the manufacturer, Tillotson Healthcare Corporation, in the USA.",
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts": "Not applicable. This is a medical device submission for surgical gloves, not a diagnostic device requiring expert interpretation of results to establish ground truth.",
  "4. Adjudication method for the test set": "Not applicable. This is a medical device submission for surgical gloves, not a diagnostic device requiring adjudication of results.",
  "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 medical device submission for surgical gloves, not an AI-assisted diagnostic tool.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a medical device submission for surgical gloves, not an AI algorithm.",
  "7. The type of ground truth used": "For non-clinical tests (Performance Standards, Water Tightness, Residual Protein), the 'ground truth' is defined by adherence to established ASTM standards (D3577-00, D5151-99, D5712-99). For clinical tests (Skin Irritation, Skin Sensitization), the 'ground truth' is implied to be established through standard safety evaluations demonstrating the glove meets or exceeds safety requirements.",
  "8. The sample size for the training set": "Not applicable. This is a medical device submission for surgical gloves, not a machine learning model requiring a training set.",
  "9. How the ground truth for the training set was established": "Not applicable. This is a medical device submission for surgical gloves, not a machine learning model."
}

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The True Advantage Non-Sterile Powder Free Purple Nitrile Patient Examination Glove is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

Nitrile films form a barrier to body fluids and bloodborne Pathogens. The nitrile rubber is water tight under normal conditions of use. It's tensile Properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Nitrile Rubber is known to create a barrier to bloodborne pathogens and and body fluids. ASTM D6319 conforming tensile properties create a glove that Is strong and flexible. The leaching process removes traces of chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the Requirements of ASTM D6319-00 and ASTM D5151-99 requirements.

Here is a summary of the acceptance criteria and the study details for the device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample sizes used for the test set and the data provenance: Not explicitly stated. The document refers to "data summaries" and general conformance to ASTM standards, but does not provide specific sample sizes for tests like water tightness, antigenic protein, guinea pig sensitization, or rabbit irritation. The data provenance is not specified beyond being generated by Tillotson Healthcare Corporation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This study focuses on objective performance testing of a physical product (examination gloves) against established ASTM and FDA standards, not an assessment requiring expert interpretation of results for ground truth establishment.

3. Adjudication method for the test set: Not applicable. The tests are objective measurements against defined standards, not requiring human adjudication.

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 is a medical device (examination glove) without an AI component or a human-in-the-loop performance aspect.

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

6. The type of ground truth used:

   • Objective Performance Standards: The ground truth for performance was established by recognized industry standards (ASTM D6319-00a, ASTM D3578-88, ASTM D5151-99, ASTM D6499-00) and an FDA water test (1988 FDA 1000 mL Water Test).
   • Predicate Device Equivalence: Safety and effectiveness "equalt to or greater than" the legally marketed predicate device (Pilgram Nitrile Latex Examination Glove K905765A) was used as a comparative benchmark.

7. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

8. How the ground truth for the training set was established: Not applicable. No training set was used.

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Cymunvera Powder Free Green Natural Rubber Latex Examination Glove lined with Aloe Vera is "a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.". (21CFR 880.6250).

Natural Rubber Latex films form a barrier to body fluids and bloodborne pathogens. The natural rubber is water tight under normal conditions of use. It's tensile properties cause it to conform to the hand, allowing movements necessary for a medical procedure. Natural Rubber Latex is known to create a barrier to bloodborne pathogens and and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The leaching process removes traces of Proteins and chemical accelerants that may be chemically irritating. The glove is manufactured in accordance with the requirements of ASTM D 3578-00a and ASTM D5151-92 requirements. This is a disposable device, intended for medical purposes, that is worn on the examiner's hand to prevent contamination between patient and examiner. Powder free gloves eliminate issues of powder contamination.

This document is a 510(k) submission for the CYMUNVERA Powder Free Green Natural Rubber Latex Patient Examination Glove lined with Aloe Vera. It focuses on demonstrating substantial equivalence to a predicate device, not on proving effectiveness for a specific clinical condition using AI. Therefore, the questions related to AI performance, multi-reader multi-case studies, and human reader improvement are not applicable to this submission.

Here's an analysis of the provided information, focusing on the relevant criteria for a medical glove:

Acceptance Criteria and Device Performance for CYMUNVERA Powder Free Green Natural Rubber Latex Patient Examination Glove

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance Criteria and Performance:

• The acceptance criteria are implicitly met by demonstrating performance that is "equal to or exceeds" the predicate device in relevant ASTM standards and safety tests.
• The "PROPOSED" column shows that the Cymunvera glove meets or exceeds the predicate's performance against these established standards. Specifically, it states "Passes" for irritation and sensitization, and utilizes a newer version of ASTM D 3578 (D 3578-00a vs D 3578-99) while maintaining the same water tightness standard.
• The primary differences highlighted are the color (green vs. white) which is a cosmetic difference and the intended use of the aloe vera lining, which is not directly assessed in this table but is implied to contribute to wearer comfort.

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

• The document does not specify sample sizes for the non-clinical tests (e.g., number of gloves tested for water tightness, number of rabbits/guinea pigs used).
• The data provenance is not explicitly stated beyond being part of a 510(k) submission by Tillotson Healthcare Corporation, based in Bedford, NH, U.S.A. It is typical for such tests to be conducted in a laboratory setting, often by third-party testing facilities. The tests are prospective in the sense that they were conducted for the purpose of this submission to verify the device's properties.

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

• Not applicable. This submission focuses on objective, standardized physical and biological tests for a medical glove, not on expert interpretation of medical images or data. The "ground truth" for these tests is defined by the ASTM standards themselves and the results of the laboratory tests.

4. Adjudication Method for the Test Set:

• Not applicable. See point 3. Testing against ASTM standards involves objective measurements, not subjective adjudication by human experts.

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 medical glove submission, not an AI/software device. No human-in-the-loop performance or AI assistance is involved.

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

• Not applicable. This is a medical glove submission, not an AI/software device.

7. The Type of Ground Truth Used:

• The ground truth for the non-clinical tests (physical performance and safety) is based on established industry standards (ASTM D 3578-00a and ASTM D5151-99) and the results of standardized laboratory testing for rabbit irritation and guinea pig sensitization. For example, water tightness is determined by whether the glove passes the specified leak rate test. "Passes" for irritation/sensitization means that the tests did not elicit a reaction above a defined threshold according to the test protocols.

8. The Sample Size for the Training Set:

• Not applicable. This product is a physical medical device, not an AI algorithm that requires a training set. The "training" for such a device would refer to its manufacturing process development and quality control, not data-driven learning.

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

• Not applicable. See point 8.

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