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510(k) Data Aggregation
(72 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Powder free vinyl patient examination gloves, non sterile that meets all of the requirements of ASTM --standard-D-5250-06
This document describes the Xuzhou Full Sun Medical Products Ltd.'s Disposable Powder Free Vinyl Synthetic Examination Glove. This device is a non-sterile, disposable examination glove made of Poly Vinyl Chloride, available in sizes XS, S, M, L, XL. It is intended for medical purposes to prevent contamination between patients and examiners. The device's performance was compared to a predicate device (K963751) and determined to be substantially equivalent based on various tests.
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria (Standard Met) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM D5250-06 | Meets ASTM D5250-06 |
| Physical Property | ASTM D5250-06 | Meets ASTM D5250-06 |
| Free of Pinhole | ASTM D5151-06 & 21 CFR 800.20 | Meets ASTM D5151-06 & 21 CFR 800.20 |
| Residue Powder | ASTM D6124-06 | Meets ASTM D6124-06 |
| Primary Skin Irritation | ISO 10993-10 | Passes |
| Dermal Sensitization | ISO 10993-10 | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (Dimension, Physical Property, Pinhole, Residue Powder, Skin Irritation, Dermal Sensitization). It only mentions that "Tests were conducted following the recommended procedures outlined in the respective consensus."
The data provenance is from China, as the manufacturer is "Xuzhou Full Sun Medical Products Ltd. Bihe Industry Area, Yitang Town Pizhou County, Jiangsu 221316 China". The data appears to be prospective as it refers to tests conducted on "Our Device" to demonstrate its performance against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is not applicable to this submission. The tests are for physical and biological properties of a medical glove, not for diagnostic accuracy that would require expert-established ground truth. The "ground truth" here is the adherence to established industry standards (ASTM, ISO, CFR) which are objective measurements.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments. For objective tests on a physical device like an examination glove, adjudication is not applicable as the results are based on standardized laboratory procedures and measurements.
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 relevant for AI algorithms or diagnostic devices where human readers interpret medical data. The device in question is a physical medical glove.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
A standalone study, generally referring to the performance of an algorithm without human intervention, is not applicable to this device. The device is an examination glove, not an AI algorithm or a diagnostic tool that involves such a performance assessment.
7. The Type of Ground Truth Used
The "ground truth" used in this context is the adherence to established industry standards and regulations. These include:
- ASTM D5250-06 (Standard Specification for Vinyl Examination Gloves)
- ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
- 21 CFR 800.20 (Puncture Resistance for Medical Gloves)
- ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
These standards define the acceptable range or threshold for each performance characteristic.
8. The Sample Size for the Training Set
Not applicable. The device is a physical medical glove and does not involve an "algorithm" or "training set" in the context of AI or machine learning. The term "training set" is typically used for developing AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As the device is not an AI algorithm, there is no "training set" or a ground truth established for one. The performance evaluation is based on direct measurement against predefined regulatory and industry standards.
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(112 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
The provided text describes the regulatory clearance for a medical device: "Xuzhou Full Sun Medical Products Ltd. Disposable Powder Free Vinyl Synthetic Exam Gloves, White Color." This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies. Therefore, much of the information typically requested for AI/algorithm-based devices (like the specifics of a study proving device meets acceptance criteria, sample sizes for training/test sets, expert involvement, and MRMC studies) is not applicable or detailed in this submission.
Here's a breakdown of the available information based on your request:
Acceptance Criteria and Device Performance
The acceptance criteria are primarily based on established ASTM standards for patient examination gloves. The device performance is reported as meeting these requirements.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Physical and Dimensions | ASTM D5250-06 | Meets all requirements of ASTM D5250-06 |
| Watertightness | FDA 1000 ml Watertight Test (based on ASTM D-5151-06) with AQL 2.5, Inspection level I | Meets requirements |
| Powder Residue | ASTM D6124-06 (for "powder-free" claim) | Contains no more than 2 mg powder per glove |
| Biocompatibility | Primary Skin Irritation | No primary skin irritant reactions |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions | |
| Lead Content | (Implicit, due to mention) | May contain 1.00 ppm of lead |
Study Details
This document is a 510(k) summary for a Class 1 medical device (patient examination glove). The "study" described is a series of non-clinical tests to demonstrate conformance to established standards and substantial equivalence to a predicate device, rather than a clinical trial validating an AI algorithm.
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Sample size used for the test set and the data provenance:
- Watertightness Test: Sampling of AQL 2.5, Inspection level I. (No specific number of gloves given, but AQL and inspection level define the sampling plan.)
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (No specific number of gloves given.)
- Biocompatibility Testing: Not specified, but standard toxicological testing would involve animal models.
- Data Provenance: Not explicitly stated, but assumed to be from internal testing by Xuzhou Full Sun Medical Products Ltd. in China, as per the manufacturer's location. The tests are "non-clinical."
- Retrospective/Prospective: Not applicable for these non-clinical tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These tests involve objective measurements against physical and chemical standards, not subjective expert interpretation of complex data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests are based on objective, quantifiable measurements against ASTM standards.
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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 physical device (glove), not an AI algorithm for diagnostic imaging or similar applications.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device is defined by the objective pass/fail criteria established by the ASTM standards (e.g., tensile strength, elongation, watertightness, powder residue limit) and biocompatibility test results.
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The sample size for the training set: Not applicable. This is a physical device, not an AI algorithm.
-
How the ground truth for the training set was established: Not applicable.
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(233 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powdered Vinyl Patient Examination Glove, 801.VZ, and meets all requirements of ASTM Standard D5250-06
Here's an analysis of the provided text regarding the acceptance criteria and study for the Disposable Powdered Vinyl Exam Glove, Yellow Color:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D5250-06, FDA 1000 ml Watertight Test, Biocompatibility testing) | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: Meets requirements as per ASTM D5250-06. (Inspection level S-2, AQL 4.0) | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0." |
| Watertight Test (Pinhole): Meets requirements as per FDA 1000 ml Watertight Test based on ASTM D-5151-06. (Sampling AQL 2.5, Inspection level I) | "The FDA 1000 ml Watertight Test based on ASTM D-5151-06 was also conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements." |
| Primary Skin Irritation: No primary skin irritant reactions. | "Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant..." |
| Skin Sensitization (Allergic Contact Dermatitis): No sensitization reactions. | "...or sensitization reactions." |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensions Testing:
- Sample Size: Not explicitly stated as a numerical value for each test. Instead, it refers to an "Inspection level S-2, AQL 4.0" which dictates the sampling plan based on the lot size.
- Data Provenance: Not explicitly stated for these tests, but the manufacturer is in China. The testing was likely conducted by the manufacturer or a contracted lab. It is retrospective, as the data is presented for a device already manufactured.
- Watertight Test (Pinhole):
- Sample Size: Not explicitly stated as a numerical value for each test. It refers to "samplings of AQL 2.5, Inspection level I" which dictates the sampling plan based on the lot size.
- Data Provenance: Not explicitly stated, but likely the same as above (retrospective, probably China-based testing facility).
- Primary Skin Irritation and Skin Sensitization:
- Sample Size: Not specified for these biological tests.
- Data Provenance: Not specified, but likely proprietary testing conducted by or for the manufacturer. It is retrospective.
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 and its testing. The "ground truth" for a medical glove is established through objective physical and chemical testing against established standards (ASTM standards, FDA watertight tests) and biocompatibility studies. It does not involve human expert interpretation or diagnosis for establishing a "ground truth" like in imaging or diagnostic AI.
4. Adjudication Method for the Test Set
This is not applicable. The nature of the testing (physical properties, watertight integrity, biocompatibility) does not require an adjudication method as would be used for subjective assessments or expert consensus in, for example, medical imaging studies. The results are objective measurements or categorical observations (e.g., irritation present/absent).
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. The device is a patient examination glove, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the impact of AI on human reader performance, which doesn't apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This device is a physical medical product (a glove), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Objective Measurement against ASTM Standards: For physical properties and dimensions (e.g., tensile strength, elongation, dimensions).
- Objective Test Results: For watertight integrity (pinhole test).
- Biocompatibility Testing Results: For primary skin irritation and sensitization, following established test protocols for biological evaluation of medical devices.
8. The Sample Size for the Training Set
This is not applicable. This device does not involve a "training set" as it is not an AI or machine learning model.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. Since there is no training set, there is no ground truth to be established for it.
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(117 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
This is a 510(k) summary for a medical device that is a disposable powder-free vinyl synthetic examination glove. The document describes the device, its intended use, and how it demonstrates substantial equivalence to a predicate device. It is not a study of an AI-powered diagnostic device, thus many of the requested categories are not applicable.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Performance / Result |
|---|---|
| Physical and Dimensions Testing | Meets requirements for Physical and Dimensions Testing based on ASTM D5250-06. (Inspection level S-2, AQL 4.0) |
| Watertight Test (Pinhole) | Meets requirements based on ASTM D-5151-06. (Samplings of AQL 2.5, Inspection level I). Also stated as "meets pinhole FDA requirements". |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (Allergic Contact Dermatitis) | No sensitization reactions. |
| Residual Powder (for "powder-free" claim) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) based on ASTM D6124-06 for Starch at finished inspection. |
| Biocompatibility | Meets biocompatibility requirements (demonstrated by Primary Skin Irritation and Skin Sensitization testing). |
| ASTM D5250-06 Compliance | Conforms fully to ASTM D-5250-06 standard. |
| Applicable 21CFR References | Conforms fully to applicable 21CFR references. |
| Labeling Claims | Meets labeling claims (as shown by data in Section 7 - which presumably refers to the "powder-free" claim and the absence of a hypoallergenic claim, as well as the 1.00 ppm lead content disclosure). Note: No special labeling claims were made, and no hypoallergenic claim was made. |
| Lead Content Disclosure | The pigment contained in the manufacture of these gloves may contain 1.00 ppm of lead (This is a disclosure, not a performance metric to meet an acceptance criterion, but it is part of the overall compliance). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Sizes:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of units sampled is not explicitly stated but is determined by the AQL and inspection level.
- Watertight Test: Samplings of AQL 2.5, Inspection level I. The exact number of units sampled is not explicitly stated.
- Primary Skin Irritation and Skin Sensitization: The document does not specify the number of subjects or samples used for these biological tests.
- Residual Powder Test: Conducted at "finished inspection," but the sample size is not specified by AQL or number of units.
- Data Provenance: The report describes non-clinical laboratory testing performed by the manufacturer. The location of the manufacturer is Xuzhou, Jiangsu Province, China. The data would therefore be considered prospective testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document describes the testing of a physical medical device (gloves), not an AI diagnostic algorithm. Therefore, the concept of "ground truth" established by experts in the context of diagnostic accuracy is not applicable here. The "ground truth" for these tests are the objective measurements against established ASTM standards and FDA requirements.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation of medical images or data requiring adjudication. The tests performed are objective, quantitative measurements against predefined 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 document pertains to physical product testing of medical gloves, not an AI-powered diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is based on established industry standards (ASTM) and FDA regulatory requirements. These are objective measurements and biological test results, not expert consensus, pathology, or outcomes data in the diagnostic sense. For example, a glove either passes the watertight test according to the AQL, or it doesn't.
8. The Sample Size for the Training Set
Not applicable. This is not an AI-powered device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI-powered device.
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(51 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06
The provided text describes a 510(k) submission for "Disposable Vinyl Examination Glove, Powdered" and does not contain information about a study proving a device meets acceptance criteria using AI or machine learning. The submission is for a medical glove, which is a physical product, not a software or AI-based device.
Therefore, the requested information fields related to AI/ML device studies (such as sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
However, I can extract the acceptance criteria and performance related to the physical glove as described in the 510(k) summary.
Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd.'s Disposable Vinyl Examination Glove, Powdered
The device is a physical product (medical glove), and its acceptance criteria and performance are based on established ASTM standards and FDA requirements for such devices. The document does not describe AI/ML performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Performance Metric | Reported Device Performance |
|---|---|---|
| ASTM D5250-06 | Physical and Dimensions Testing | Meets all requirements, Inspection level S-2, AQL 4.0 |
| FDA 1000 ml Watertight Test (based on ASTM D-5151-06) | Pinhole Rate | Meets requirements, AQL 2.5, Inspection level I |
| Biocompatibility (Primary Skin Irritation) | Skin Irritation | No primary skin irritant reactions |
| Biocompatibility (Skin Sensitization) | Skin Sensitization | No sensitization reactions (allergic contact dermatitis) |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact sample size (number of gloves tested) is not specified but is implied by the AQL (Acceptance Quality Limit) and inspection level, which are standard statistical sampling plans.
- FDA 1000 ml Watertight Test: AQL 2.5, Inspection level I. The exact sample size is not specified but is implied by the AQL and inspection level.
- Biocompatibility Testing: The number of subjects or samples used for primary skin irritation and sensitization testing is not specified in this summary.
- Data Provenance: The tests were performed by the manufacturer, Xuzhou Full Sun Medical Products Ltd. (China). The data is presented retrospectively as part of the 510(k) submission for marketing clearance.
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 a medical glove involves physical properties and biological reactions, which are determined by standardized laboratory tests and assessments, not expert consensus on interpretations like with AI/imaging.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of interpretations. Test results are objective measurements against predefined 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 physical product (glove), not an AI-assisted diagnostic device.
6. 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.
7. The type of ground truth used
- Physical and Dimensions: The truth is defined by the specifications and tolerances outlined in ASTM D5250-06.
- Pinhole Detection: The truth is defined by the absence of leaks as per the FDA 1000 ml Watertight Test based on ASTM D-5151-06.
- Biocompatibility: The truth is defined by the absence of observable adverse reactions (irritation, sensitization) in standard biological tests.
8. The sample size for the training set
Not applicable. This is a manufactured product, referring to "training set" doesn't apply in the context of AI/ML. Manufacturing processes are "trained" through quality control and process adjustments, but not in the AI sense.
9. How the ground truth for the training set was established
Not applicable. Again, this refers to AI/ML context, which is not relevant here. Manufacturing quality is maintained through adherence to Good Manufacturing Practices (GMP) and ongoing quality control, referencing the same ASTM standards.
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(49 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
The provided text is for a 510(k) summary for Disposable Powder Free Vinyl Exam Gloves. This type of device does not typically undergo studies with the kind of acceptance criteria, test sets, expert ground truth, MRMC studies, or standalone performance assessments that are relevant to AI/ML medical devices or complex diagnostic tools.
The "studies" described in this document are primarily non-clinical tests to ensure the physical properties and safety of the gloves meet established standards for medical devices.
Therefore, many of the requested categories (2-6, 8-9) are not applicable to this submission as they pertain to clinical or diagnostic performance, which is not evaluated for examination gloves in this manner.
Here's an interpretation based on the available information:
Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd. Disposable Vinyl Examination Glove, Powder Free
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Criterion | Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|---|
| Physical and Dimensions Testing | ASTM D5250-06 | Meets requirements (Section 7) |
| Watertight Test (Pinhole integrity) | FDA 1000 ml based on ASTM D-5151-06 (AQL 2.5, Inspection level I) | Meets requirements (Section 7) |
| Primary Skin Irritation | Acceptable biocompatibility | No primary skin irritant reactions (Section 7) |
| Skin Sensitization (Allergic Contact Dermatitis) | Acceptable biocompatibility | No sensitization reactions (Section 7) |
| Residual Powder | ASTM D6124-06 (no more than 2 mg powder per glove) | Meets "powder-free" claims (Section 7) |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact number of samples is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) for the given batch size. Provenance is not specified, but the testing was done for the manufacturer (Xuzhou Full Sun Medical Products Ltd.) in China. This is retrospective testing of manufactured batches.
- Watertight Test: AQL 2.5, Inspection level I. The exact number of samples is not explicitly stated. Provenance is not specified, but the testing was done for the manufacturer. This is retrospective testing.
- Primary Skin Irritation and Skin Sensitization: Sample sizes for these biocompatibility tests are not disclosed but would follow standard biological test protocols. Provenance or specific subjects are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. For physical and biocompatibility testing of medical gloves, ground truth is established by standardized test methods and laboratory analysis, not by human expert consensus or interpretation in the way it is for diagnostic imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. This concept is not applicable to the non-clinical testing of examination gloves. Test results are objective measurements against a standard.
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
N/A. This device is an examination glove; it does not involve AI, human readers, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is an examination glove; it is not an algorithm and does not have standalone performance in the context of AI.
7. The type of ground truth used
For physical and dimensions testing, watertight testing, and residual powder testing, the "ground truth" is defined by the numerical specifications and limits set by the applicable ASTM and FDA standards (e.g., ASTM D5250-06, ASTM D-5151-06, ASTM D6124-06). For primary skin irritation and skin sensitization, the "ground truth" is established by biocompatibility test guidelines that determine the absence of adverse biological reactions.
8. The sample size for the training set
N/A. This device does not involve a "training set" in the context of machine learning or complex model development. The manufacturing process of gloves is subject to quality control, but not a "training set" in this sense.
9. How the ground truth for the training set was established
N/A. See point 8.
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(98 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06.
Here's the breakdown of the acceptance criteria and study information based on the provided text, focused on the aspects typically used to describe medical device performance studies:
Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd. Disposable Powder Free Vinyl Exam Glove Yellow Color
This 510(k) summary primarily addresses the substantial equivalence of a disposable medical glove to a predicate device, focusing on material and physical integrity rather than a complex AI or diagnostic performance study. As such, the typical metrics for diagnostic device performance (e.g., sensitivity, specificity, AUC) are not applicable. Instead, the acceptance criteria relate to compliance with established ASTM standards and FDA requirements for patient examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Performance Metric | Reported Device Performance |
|---|---|---|
| Physical and Dimensions Testing (ASTM D5250-06) | Meets requirements for physical properties and dimensions. | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection level S-2, AQL 4.0." |
| Watertight Test (ASTM D-5151-06) | Watertight integrity (Pinhole detection). | "The FDA 1000 ml Watertight Test based on ASTM D-5151-06 was also conducted with samplings of AQL 2.5, Inspection level I, meeting these requirements." |
| Primary Skin Irritation | Absence of primary skin irritant reactions. | "Primary Skin irritation... testing was conducted with results showing no primary skin irritant... reactions." |
| Skin Sensitization (allergic contact dermatitis) | Absence of sensitization reactions. | "Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no... sensitization reactions." |
| Residual Powder Test (ASTM D6124-06 for starch) | Powder content for "powder-free" claim (≤ 2 mg/glove). | "A residual Powder test that based on ASTM D6124-06 for Starch at finished inspection is conducted to insure that our gloves meet our 'powder-free' claims (contain no more than 2 mg powder per gloves)." |
| Biocompatibility | Satisfies biocompatibility requirements. | "meets... biocompatibility requirements" (implied by skin irritation/sensitization tests and general compliance). |
| Labeling Claims | Consistency with regulatory guidelines. | "meets... labeling claims" |
2. Sample Size Used for the Test Set and Data Provenance
The document provides specific sample sizes and inspection levels for certain tests:
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. (Exact numerical sample size not specified, but refers to a standard sampling plan).
- Watertight Test: AQL 2.5, Inspection level I. (Exact numerical sample size not specified, but refers to a standard sampling plan).
- Skin irritation and Sensitization testing: Sample size not specified.
- Residual Powder Test: Sample size not specified.
The data provenance is the manufacturer, Xuzhou Full Sun Medical Products Ltd., in Jiangsu Province, China. The studies are prospective in the sense that they are performed on the manufactured product to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This device is a Class I medical device (patient examination glove), and the compliance is assessed through standardized physical, chemical, and biological tests, not through expert interpretation of medical images or diagnostic data. Therefore, "ground truth" as typically defined for AI or diagnostic devices is not established by a panel of experts. The standards themselves define the "ground truth" for acceptable performance.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements or established biological assays, not subjective assessments 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
Not applicable. This is not a diagnostic device or an AI-powered system that involves human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The tests performed are standalone in the sense that they assess the device's inherent properties.
7. The Type of Ground Truth Used
The "ground truth" is defined by adherence to accepted industry standards and regulatory requirements. This includes:
- ASTM Standard D5250-06: For physical and dimensional properties of vinyl examination gloves.
- ASTM Standard D-5151-06: For pinhole detection in medical gloves (watertight test).
- ASTM Standard D6124-06: For residual powder content.
- Biocompatibility principles: Demonstrated through skin irritation and sensitization tests.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML model, this question is not relevant.
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