Search Results

The POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed device was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

The proposed device, POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device is a Powder Free Nitrile Patient Examination Glove that is available in multiple sizes

The proposed device is provided non-sterile. The proposed device is made of Nitrile. The proposed device acts as a barrier.

The document provided is a 510(k) premarket notification for "POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria, statistical analysis, and expert ground truth consensus typical for AI-powered diagnostic devices.

Therefore, the requested information about acceptance criteria, efficacy study design, sample sizes for test and training sets, expert qualifications, and adjudication methods (sections 1-9 of your prompt) does not directly apply in the context of this 510(k) submission for medical gloves.

The "study" in this context refers to bench testing against established industry standards for medical gloves, and the "acceptance criteria" are the performance specifications outlined in those standards.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are derived from various ASTM and ISO standards for medical gloves. The reported device performance indicates compliance with these standards.

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

The document does not specify exact sample sizes for each test within the standards (e.g., how many gloves were tested for permeation, holes, etc.). However, it refers to standards like ISO 2859-1:1999 ("Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection"), which would dictate the sample sizes used for quality control aspects like freedom from holes.

The data provenance is from bench testing conducted by the manufacturer, Hebei Hongsen Plastics Technology Co., Ltd. The country of origin for the manufacturing and testing data would be China, as indicated by the manufacturer's address. This is retrospective testing performed to demonstrate compliance for a new device submission.

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

Not applicable. For medical gloves, "ground truth" is established by adherence to physical, chemical, and biological performance standards, not by expert consensus on clinical data interpretation. The tests are objective measurements (e.g., breakthrough time, tensile strength, presence of holes).

4. Adjudication method for the test set

Not applicable. The tests are objective measurements according to standardized protocols, eliminating the need for adjudication among human readers.

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, not an AI-powered diagnostic device. No human-in-the-loop performance or AI assistance considerations are relevant.

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

Not applicable. This is a medical glove.

7. The type of ground truth used

The "ground truth" for the device's performance is established by objective measurements and adherence to performance specifications defined in international and national standards, such as:

• Physical properties (tensile strength, elongation)
• Dimensional properties (length, width, thickness)
• Freedom from holes
• Chemical permeation (chemotherapy drugs)
• Biological safety (irritation, sensitization)

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device. The manufacturing process is designed to produce gloves meeting specifications, and the testing confirms this.

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

Not applicable. There is no training set.

Ask a specific question about this device

The POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The proposed device, POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

Powder Free Nitrile Patient Examination Gloves are made of Nitrile rubber; available in four different colors (White, Cobalt Blue, Black, and Ice Blue) and five different sizes (XS-XL). The subject device is provided non-sterile and is a barrier.

The provided document is a 510(k) summary for POWDER FREE Nitrile GLOVES. It describes the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

Device Name: POWDER FREE Nitrile GLOVES (White, Cobalt Blue, Black, Ice Blue)
Predicate Device Name: Powder free Patient Examination Gloves, Blue Color (K131440)

Note: "SE" in the "Comparison Result" column indicates "Substantially Equivalent" based on the provided document. "Analysis 1, 2, 3" refer to the specific analyses provided in the document to justify substantial equivalence despite minor differences.

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

The document describes non-clinical bench tests performed to verify design specifications and compliance with standards. It does not provide specific sample sizes for these tests.

• Sample Size for Test Set: Not explicitly stated for each test (e.g., number of gloves tested for tensile strength or holes). The document refers to compliance with standards like ASTM D6319 and ISO 2859-1 which define sampling procedures (e.g., AQL for lot-by-lot inspection), but the specific number of units tested is not given.
• Data Provenance: The tests were conducted internally by the manufacturer, HEBEI HONGSEN PLASTICS TECHNOLOGY CO., LTD, or a contracted lab for biocompatibility. The country of origin for the data is implicitly China, where the manufacturer is located. The nature of the tests (bench tests, physical property measurements, chemical analysis) is retrospective from the perspective of their inclusion in the 510(k) submission, confirming existing product specifications.

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

Not applicable for this type of device and study. The "ground truth" for medical gloves is established by compliance with recognized consensus standards (e.g., ASTM, ISO) which define acceptable physical properties, safety, and performance characteristics. These standards are developed through expert consensus within respective fields, but no individual experts are cited as establishing ground truth for this specific submission's test set.

4. Adjudication Method for the Test Set

Not applicable. The objective performance metrics are measured against quantitative specifications defined by the relevant ASTM and ISO standards. There is no subjective assessment or adjudication required.

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 typically used for diagnostic devices that involve human interpretation of images or other data to assess the impact of an AI algorithm on human reader performance. Nitrile examination gloves do not involve human interpretation in a diagnostic context.

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

Yes, the studies presented are effectively "standalone" in the context of the device's function. The performance metrics (tensile strength, elongation, freedom from holes, powder content, biocompatibility, dimensions) are inherent properties of the glove itself, measured directly through physical and chemical tests, independent of human interaction during their use. There is no AI algorithm in this device.

7. The Type of Ground Truth Used

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

• Consensus Standards: Specifically, ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application), ASTM D5151-06 (Reapproved 2011) (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D6124-06 (Reaffirmation 2011) (Standard Test Method for Residual Powder on Medical Gloves), and ISO 10993-10: 2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization).
• Predicate Device Performance: The predicate device serves as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical glove, not an AI/ML algorithm that requires a training set. The term "training set" is relevant for AI models, not for traditional medical devices like examination gloves.

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

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

Ask a specific question about this device

The powder free nitrile surgical glove, white color (Brand Name: Titanfine), is a sterile and single use device 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.

Surgical glove is a disposable device worn on the surgical room personnel's hand or finger to prevent contamination during surgical procedures. The principle of operation is to provide a physical barrier between the surgical personnel's hands and the patient's open wound.

The powder free nitrile surgical gloves described in this submission are made of synthetic nitrile rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have white color and are single use.

The powder free nitrile surgical gloves described in this submission are tested for dimension, percent elongation, tensile, tensile at 500% elongation, free of pinholes, residue powder, water soluble proteins. The test results conform to related requirements in ASTM 3577-2009.

The powder free nitrile surgical gloves described in this submission are also tested biocompatibility per ISO 10993-10. The test results conform to related requirements in the standard.

The product sterilization is performed using radiation and the procedure is validated per ISO 11137-2: 2006.

This document is a 510(k) premarket notification for Powder Free Sterile Nitrile Surgical Gloves, White Color (Brand Name: Titanfine). It does not describe a study involving an AI device and human readers, but rather the substantial equivalence of a medical device (surgical gloves) to a predicate device. Therefore, many of the requested categories related to AI performance, human expert evaluation, and training/test sets are not applicable.

However, I can extract the acceptance criteria and demonstrated performance for the surgical gloves based on the provided text.

Here's a summary of the requested information, adapted for this medical device submission:

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

Ask a specific question about this device

The powder free sterile latex surgical glove, yellow color (Brand Name: Titanfine), is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine) are made of natural rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have yellow color.

This document describes the premarket notification for Powder Free Sterile Latex Surgical Gloves, Yellow Color (Brand Name: Titanfine). The study proves the device meets the acceptance criteria by demonstrating its compliance with various ASTM standards and ISO 10993-10 for physical, biocompatibility, and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test or the specific data provenance (e.g., country of origin, retrospective or prospective nature) for the testing. It generally states that "Tests were conducted following the recommended procedures outlined in the respective consensus standards."

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

Not applicable. The ground truth for this device is based on compliance with established technical standards (ASTM and ISO), not expert consensus in a diagnostic sense.

4. Adjudication method for the test set

Not applicable. The test results are pass/fail based on meeting the specified criteria of the referenced standards.

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 (surgical gloves), not an AI/imaging diagnostic device.

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

Not applicable. This is a medical device (surgical gloves), not an algorithmic device.

7. The type of ground truth used

The ground truth used for demonstrating compliance is based on established industry standards and physical/chemical testing results. Specifically:

• Physical properties and dimensions: ASTM D3577-09
• Freedom from pinholes: ASTM D5151 (AQL 1.5)
• Residual powder: ASTM D6124
• Water-soluble protein: ASTM D5712-10
• Biocompatibility (primary skin irritation and dermal sensitization): ISO 10993-10: 2010

8. The sample size for the training set

Not applicable. This is a medical device (surgical gloves), not an AI/machine learning device that requires a training set. The "training" in this context refers to the manufacturing process ensuring consistency with quality standards.

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

Not applicable. As this is not an AI/machine learning device, there is no "training set ground truth" in that sense. The manufacturing process is designed to produce gloves consistently meeting the established standards.

Ask a specific question about this device

The Titan powder free nitrile patient examination glove, blue color, is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. It has blue color and is sold as non sterile.

Powder free nitrile examination gloves are made of synthetic nitrile rubber, and are non sterile that meets all of the requirements of ASTM standard D 6319-10, except for sterility requirements. They have blue color.

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

Device: Powder Free Patient Examination Gloves, Blue Color (Brand Name: Titans)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the individual tests (e.g., for pinhole detection, physical properties, or biocompatibility). It only indicates that "Tests were conducted following the recommended procedures outlined in the respective consensus standards." The data provenance (country of origin, retrospective/prospective) and specific sample sizes for these tests are not provided in the summary.

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

Not applicable. This device is a patient examination glove, and the testing involves adherence to established ASTM and ISO standards for physical properties, performance, and biocompatibility. Ground truth in this context is defined by the objective measurements and pass/fail criteria of these standards, not by expert interpretation or consensus on images or clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" is based on objective measurements against consensus standards, an adjudication method for reconciling expert opinions is not necessary or mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret data (e.g., medical images) and AI might assist them. For patient examination gloves, the evaluation centers around predetermined physical, chemical, and biological performance standards.

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

Not applicable. This is a physical medical device (gloves), not an algorithm or AI. Performance is assessed through standardized laboratory tests, not by an algorithm.

7. The Type of Ground Truth Used

The ground truth used is based on established consensus standards (ASTM D6319-10, ASTM D5151, ASTM D6124, ISO 10993-10) with specific, objective pass/fail criteria for dimensions, physical properties, absence of pinholes, residue powder levels, and biocompatibility endpoints (skin irritation and sensitization).

8. The Sample Size for the Training Set

Not applicable. This device is a manufactured product (gloves), not an AI algorithm requiring a training set.

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

Not applicable. As there is no AI algorithm or training set, this question is not relevant to the described device.

Ask a specific question about this device