Search Results

Nitrile Powder Free Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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 glove is known to create a barrier to bloodborne pathogens and body fluids. ASTM conforming tensile properties create a glove that is strong and flexible. The glove is manufactured in accordance with the requirements of ASTM D6319 and ASTM D5151 requirements.

The provided document is a 510(k) summary for the Nitrile Powder Free Patient Examination Gloves, Blue Color (K152712). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a novel device meets specific acceptance criteria through a clinical study involving AI or human readers.

Therefore, many of the requested fields are not applicable to the context of this document.

Here's the information that can be extracted from the provided text, formatted to address your request:

Acceptance Criteria and Device Performance

Study Details (Based on the Provided Document which is a 510(k) Summary)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document does not specify general "test set" sample sizes or data provenance in the context of clinical studies for performance evaluation of a device like an AI. Instead, it refers to compliance with ASTM standards and biocompatibility studies. The specific sample sizes for tests like pinhole detection, tensile strength, or biocompatibility are not detailed, but implied to be sufficient for standard compliance.
   • Data Provenance: Not explicitly stated for each test, but the submitter is Zhonghong Pulin Medical Products Co., Ltd. from Hebei, China. Biocompatibility studies specify rabbits and guinea pigs.

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 medical glove, not an AI diagnostic device requiring expert interpretation for ground truth. Ground truth for its performance properties is established through standardized physical, chemical, and biological testing as per ASTM and ISO standards.

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

   • Not applicable. This concept is relevant for studies where human interpretation of medical data and subsequent consensus is needed to establish ground truth (e.g., in diagnostic AI), which is not the case for a patient examination glove.

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 device is a medical glove, not an AI system or software requiring comparison of human reader performance with and without AI assistance.

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

   • Not applicable. This is a physical medical device (glove), not an algorithm.

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

   • The "ground truth" for the device's performance is established by conformance to established industry standards (ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, 21 CFR 800.20) and biocompatibility testing results (ISO 10993-10). For example, "Freedom from pinholes" has a ground truth defined by the water leak test method described in 21 CFR 800.20. Biocompatibility has ground truth based on observed biological reactions in animal models.

8. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or AI models with training sets.

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

   • Not applicable. This device does not involve machine learning or AI models with training sets.

Ask a specific question about this device

Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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.

Powder Free Nitrile Patient Examination Gloves , Blue Color that meets all of the requirements of ASTM standard D 6139-10

This document is a 510(k) summary for a medical device called "Powder Free Nitrile Patient Examination Gloves, Blue Color." It aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device.

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

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

The provided text does not explicitly state the sample sizes used for the various tests.
The data provenance is not explicitly stated as retrospective or prospective, nor does it specify the country of origin of the data. However, the manufacturer is from China (Tangshan Zhonghong Pulin Plastic Co., Ltd., China), suggesting the testing might have been conducted there or through certified labs.

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

This type of information is not applicable to this device. The testing involves adherence to established technical standards (ASTM, CFR, ISO) for physical properties and biocompatibility, not expert interpretation of diagnostic images or clinical outcomes. The "ground truth" is defined by the objective pass/fail criteria of these standards.

4. Adjudication Method for the Test Set

This information is not applicable to this device. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation or clinical events, not for standardized physical and chemical property testing of a product like examination gloves. The testing follows predefined methodologies within the cited standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted and is not relevant for this device. Such studies are typically performed for diagnostic or screening devices where human readers interpret results, often with AI assistance. This device is a patient examination glove, and its effectiveness is determined by its physical and biological properties.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study was not conducted and is not relevant for this device. This concept applies to AI/software algorithms. The "performance" of these gloves is their intrinsic material and functional characteristics, which are tested through laboratory methods.

7. Type of Ground Truth Used

The ground truth used for this device is based on established technical standards and regulatory requirements. Specifically:

• Physical properties (Dimension, Physical Properties, Freedom from pinholes, Powder Residual): Defined by the specified ASTM standards (D 6139-10, D 5250-06, D6124-06) and FDA regulation (21 CFR 800.20). The "ground truth" is whether the glove's measured properties fall within the acceptable ranges or thresholds defined by these standards.
• Biocompatibility: Defined by the results of specific animal tests (Primary Skin Irritation in rabbits, Dermal Sensitization in guinea pigs) which have clear "Pass" criteria for demonstrating absence of irritation or sensitization. The ISO 10993-10 standard would outline the methodology and criteria for these tests.

8. Sample Size for the Training Set

This information is not applicable to this device. The concept of a "training set" belongs to machine learning and AI algorithms. The manufacturing process of gloves does not involve a training set in this context. The "training" for manufacturing would be the established quality control and production procedures.

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

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device

Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05

This document pertains to the 510(k) premarket notification for "Nitrile Powder Free Patient Examination Gloves, Coloured (Blue)" submitted by Tangshan Xiangrui Plastic Products Co., Ltd. The product is a disposable, non-sterile glove intended for medical purposes to prevent cross-contamination.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is assessed against established industry standards and FDA regulations for patient examination gloves.

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

The document does not explicitly state the specific sample sizes for each test mentioned (Dimension, Physical Properties, Freedom from Pinhole, Powder Residual, Biocompatibility). However, it implies that the testing was performed on samples of the "Nitrile Powder Free Patient Examination Gloves, Coloured (Blue)" manufactured by the applicant.

The data provenance is from non-clinical testing performed on the applicant's device. The country of origin of the data is not explicitly stated, but given the applicant's location (Tangshan City, Hebei Province, China), it can be inferred that the testing was likely conducted in China or by labs contracted by the Chinese manufacturer. The testing is prospective in the sense that it was conducted on the newly manufactured device to demonstrate its conformity to standards.

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

This information is not applicable as the evaluations for this device (patient examination gloves) are based on objective, standardized physical and chemical tests, not on expert interpretation of complex data or images. The "ground truth" is defined by the objective pass/fail criteria of the ASTM standards and CFR regulations.

4. Adjudication Method for the Test Set

This information is not applicable. The tests performed are objective and quantitative (e.g., measuring dimensions, tensile strength, liquid leakage, chemical residue). They do not involve subjective interpretation that would require an adjudication method like 2+1 or 3+1.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and AI's assistance to these readers is evaluated. Patient examination gloves do not involve such a scenario.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This information is not applicable. Patient examination gloves are a physical product, not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.

7. Type of Ground Truth Used

The ground truth used for evaluating the device is based on objective, quantitative standards and regulatory requirements. Specifically:

• ASTM standard D 6139-05 for Dimension and Physical Properties.
• 21 CFR 800.20 for Freedom from pinholes.
• ASTM standard D 5250-06 and D6124-06 for Powder Residual.
• ISO10993-10 (implied for biocompatibility based on the discussion in b(1)) and general biocompatibility testing protocols for Primary Skin Irritation (in rabbits) and Dermal sensitization (in guinea pigs).

8. Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as no training set was used.

Ask a specific question about this device

Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05

Here's a breakdown of the acceptance criteria and study information based on the provided text:

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 specific sample sizes used for each test (e.g., how many gloves were tested for pinholes, or how many animals were used for biocompatibility tests). It only refers to compliance with the standards, which would implicitly define sample sizes within those standards.

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be data collected to demonstrate compliance with the referenced ASTM standards and CFR regulations.

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

This information is not applicable and not provided in the document. The "ground truth" for glove testing is established by objective measurements against predefined criteria in the referenced standards (e.g., tensile strength, elongation, water leak test for pinholes, chemical analysis for powder residue, animal studies for biocompatibility). These are not expert interpretations requiring adjudication in the way medical imaging diagnosis would.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human interpretation studies (e.g., radiology reads). For physical or chemical testing of medical devices like gloves, the assessment is based on direct measurement and meeting specified thresholds in standards, not subjective expert opinion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human reader performance is being evaluated. This document pertains to a physical medical device (examination gloves), not a diagnostic AI system.

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

This is not applicable. This document describes the performance of a physical device (examination gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by objective measurements and chemical/biological tests against the specific criteria and methodologies outlined in the referenced ASTM standards (D 6139-05, D 5250-06, D6124-06) and FDA regulations (21 CFR 800.20, ISO10993-10). Examples include:

• Dimensional measurements (e.g., length, width, thickness).
• Physical property tests (e.g., tensile strength, elongation at break).
• Water leak tests for freedom from pinholes.
• Chemical analysis to quantify powder residue.
• Animal studies (rabbits for primary skin irritation, guinea pigs for dermal sensitization) for biocompatibility.

8. The Sample Size for the Training Set

This is not applicable. This device is a physical product, not a software or AI model that requires a training set.

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

This is not applicable. As stated above, this device does not involve a training set.

Ask a specific question about this device

Nitrile Powder Free Patient Examination Gloves, Coloured (Blue) 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.

Nitrile Powder Free Patient Examination Gloves that meets all of the requirements of ASTM standard D 6139-05

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nitrile Powder Free Patient Examination Gloves.

It's important to note that this document is a 510(k) summary for a Class I medical device (gloves). For such devices, clinical studies are typically not required, and the focus is on meeting established performance standards (ASTM, FDA regulations). Therefore, many of the typical AI/software device evaluation criteria (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies) are not applicable or present in this submission.

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • The document does not specify explicit sample sizes for the individual tests (Dimension, Physical Properties, Freedom from pinholes, Powder Residual, Biocompatibility). These are typically quality control tests performed on batches of gloves according to the relevant ASTM or ISO standards.
   • Data provenance is not explicitly stated, but given the manufacturer is based in China, it is highly likely the testing was conducted there. The testing is prospective in the sense that it evaluates the manufactured product against predefined standards.

2. 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)

   • This criterion is not applicable. The "ground truth" for glove performance involves objective measurements and adherence to specified physical and chemical properties defined by standards (ASTM, ISO, CFR). It does not rely on expert interpretation in the same way clinical diagnostic devices do. Biocompatibility tests are conducted by specialized laboratories.

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

   • Not applicable. Performance is determined by objective measurements against numerical or qualitative pass/fail criteria defined in the standards, not by expert 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 device is a physical examination glove, not an AI-powered diagnostic tool. MRMC studies are not relevant.

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

   • Not applicable. This is a physical product, not an algorithm or software.

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

   • The "ground truth" for this device's performance is based on objective measurements against established engineering and material science standards (ASTM D6139-05, ASTM D5250-06, ASTM D6124-06, 21 CFR 800.20, ISO10993-10). This includes dimensional accuracy, physical strength, integrity (freedom from pinholes), chemical residue, and biological reaction (irritation, sensitization).

7. The sample size for the training set

   • Not applicable. This concept pertains to machine learning models, which are not relevant for this device.

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

   • Not applicable, as there is no training set in the context of this device.

Summary of the Study:

The "study" demonstrating the device meets acceptance criteria is primarily a series of non-clinical bench and lab tests against well-established international and national standards. The manufacturer conducted these tests and reported that their Nitrile Powder Free Patient Examination Gloves "Meets" or "Passes" all specified criteria from ASTM D 6139-05, 21 CFR 800.20, ASTM D 5250-06, ASTM D6124-06, and ISO10993-10. These tests cover the critical performance aspects for patient examination gloves, including their physical integrity, durability, and biocompatibility, ensuring they are safe and effective for their intended medical purpose of preventing contamination. No clinical data was required or submitted, as is typical for this type of device.

Ask a specific question about this device

Powder Free Blue Patient Nitrile Examination Gloves 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.

Powder Free Blue Patient Nitrile Examination Gloves that meets all of the requirements of ASTM D 6139-05

Acceptance Criteria and Device Performance Study

This document describes the acceptance criteria for the "Powder Free Blue Patient Nitrile Examination Gloves" and the study that demonstrates the device meets these criteria.

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 size used for the test set for each characteristic. However, the testing was conducted on the "Powder Free Blue Patient Nitrile Examination Gloves" manufactured by Tangshan Luxiong Plastic Products Co.,Ltd. The data provenance is not specified as retrospective or prospective, but it can be inferred that the testing was conducted specifically for this device as part of its premarket notification process. The country of origin of the device is China.

3. Number of Experts and their Qualifications for Ground Truth

The concept of "experts" and "ground truth" as typically applied to AI/ML device studies (e.g., radiologist consensus) is not directly applicable here. The device is a medical glove, and its performance is evaluated against established physical, chemical, and biological standards. Therefore, the "ground truth" is defined by these standards, and the "experts" would be the certified laboratories and personnel conducting the specified tests according to the standard operating procedures of each test. Their qualifications would be their certification and experience in performing these specific tests (e.g., in material science testing, biological safety testing).

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are not applicable to the testing of medical gloves against performance standards. The results of the tests (e.g., whether a dimension meets the specification, whether a sample passes the pinhole test) are objective measurements or categorical outcomes that do not require human interpretation or consensus in the same way as an image diagnosis. The "adjudication" is inherent in the methodology of the standard test itself, where specific pass/fail criteria are defined.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or AI-assisted medical devices where human readers interpret medical images or data. The "Powder Free Blue Patient Nitrile Examination Gloves" is a physical barrier device, and its effectiveness is determined by its physical and biological properties.

6. Standalone Performance (Algorithm Only)

A standalone performance study (algorithm only) was not done. This device is not an algorithm or AI system. Its performance is entirely physical and biological, as assessed through laboratory testing.

7. Type of Ground Truth Used

The type of ground truth used is based on established industry standards and regulatory requirements. Specifically:

• ASTM D 6139-05: For Dimension and Physical Properties.
• 21 CFR 800.20: For Freedom from pinholes.
• ASTM D 5250-00c4 and D6124-01: For Powder Residual.
• ISO10993-10: For Biocompatibility (Primary Skin Irritation and Dermal sensitization).

These standards define the methodologies, acceptance criteria, and expected performance for patient examination gloves.

8. Sample Size for the Training Set

A "training set" is not applicable to this device. This is not an AI/ML device that requires machine learning model training. The device's manufacturing process is controlled to meet the specified standards, and batches are tested to ensure compliance.

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

As there is no training set for an AI/ML model, the concept of establishing ground truth for a training set is not relevant here. The "ground truth" for the device's performance is inherently defined by the objective, predetermined pass/fail criteria within the ASTM and ISO standards mentioned above. These standards are developed through expert consensus within their respective organizations (ASTM, ISO) and are widely accepted in the industry and by regulatory bodies.

Ask a specific question about this device

The medical gloves are worn on the hands of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Nitrile Powder Free Patient Examination Gloves

This document is a 510(k) clearance letter from the FDA for Nitrile Powder Free Patient Examination Gloves. It does not contain any information about acceptance criteria or a study proving device performance in the context of medical devices that typically involve AI or complex algorithms.

The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. This determination is based on the device meeting general controls provisions and Good Manufacturing Practice (GMP) regulations, not on specific performance metrics from a clinical study as would be described for an AI-powered diagnostic device.

Therefore, I cannot provide the requested information from the provided document.

Ask a specific question about this device