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510(k) Data Aggregation
(88 days)
Medical 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.
The proposed device, Medical Nitrile Examination Gloves, is a powder free patient examination glove, it is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The device is provided in blue, purple, white and black colors. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in four sizes, which are S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
The medical device being discussed is "Medical Nitrile Examination Gloves" (K232576). The provided document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving clinical efficacy via extensive studies with human subjects.
Therefore, the requested information regarding multi-reader multi-case studies, human reader improvement with AI assistance, and the number of experts for ground truth establishment are not applicable as this is a physical medical device (gloves) and not an AI/software device.
Here's the breakdown 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
The non-clinical tests conducted to demonstrate substantial equivalence are summarized in the following table. The "Results (Pass/Fail)" column directly indicates whether the device met the stated acceptance criteria.
| Test Methodology | Purpose | Acceptance Criteria | Specifics | Reported Device Performance (Pass/Fail) |
|---|---|---|---|---|
| ASTM D6319-19, ASTM D3767-03 (2020) | Physical Dimensions | Width | S: 80±10mm | |
| M: 95±10mm | ||||
| L: 110±10mm | ||||
| XL: 120±10mm | Pass | |||
| Length | S: 220mm min | |||
| M: 230mm min | ||||
| L: 230mm min | ||||
| XL: 230mm min | Pass | |||
| Thickness | Palm: 0.05mm min | |||
| Finger: 0.05mm min | Pass | |||
| ASTM D6319-19, ASTM D412-16 | Physical Properties | Before Aging | Tensile Strength: 14MPa min | |
| Ultimate Elongation: 500% min | Pass | |||
| After Aging | Tensile Strength: 14MPa min | |||
| Ultimate Elongation: 400% min | Pass | |||
| ASTM D5151-19 | Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 | - | Pass |
| ASTM D6124-06 | Powder Free Residue | Less than 2mg per glove | - | Pass |
| ISO 10993-10:2010 | Irritation | Non-Irritating | - | Pass |
| ISO 10993-10:2010 | Sensitization | Non-Sensitizing | - | Pass |
| ISO 10993-11:2009 | Acute Systemic Toxicity | Non-toxicity | - | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes (number of gloves or test samples) used for each specific non-clinical test (e.g., how many gloves were tested for dimensions, tensile strength, or holes). However, the tests were conducted according to recognized international and national standards (ASTM and ISO), which typically specify appropriate sampling plans and methodologies.
The data provenance is from non-clinical tests conducted by the manufacturer, Jiangsu Complete Sincerity Medical New Materials Co., Ltd., in China. The tests are retrospective in the sense that they were performed on samples of the manufactured device to demonstrate compliance with standards for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. For a physical device like examination gloves, "ground truth" is established by direct measurement and standardized testing against predefined physical and chemical properties as specified in the ASTM and ISO standards. There is no subjective interpretation by medical experts required for these types of tests.
4. Adjudication Method for the Test Set
This question is not applicable. As explained above, the assessment is based on objective, standardized tests with pass/fail criteria. There is no need for human adjudication of results in the traditional sense of medical image interpretation or clinical outcomes.
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 an AI/software device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used
The ground truth used for this device's evaluation is based on:
- Standardized measurement values: For dimensions (width, length, thickness), tensile strength, and elongation percentage as defined by ASTM D6319-19, ASTM D3767-03, and ASTM D412-16.
- Absence of defects/undesirable characteristics: For freedom from holes (ASTM D5151-19) and powder-free residue (ASTM D6124-06).
- Biological responses/toxicity: Absence of irritation, sensitization, and acute systemic toxicity as defined by ISO 10993-10:2010 and ISO 10993-11:2009.
These are objective, quantifiable, and internationally recognized criteria for medical gloves.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/machine learning model. There is no "training set" in the context of this 510(k) submission.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this physical device.
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(83 days)
The Medical Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: S,M,L,XL. The subject device is non-sterile.
The provided text describes the 510(k) summary for the "Medical Nitrile Examination Gloves" (K220066). This document is for a Class I medical device (non-powdered patient examination glove), which is a low-risk device. For such devices, clinical testing is typically not required, and the focus of the submission is on non-clinical performance and substantial equivalence to a predicate device.
Therefore, the requested information regarding AI device performance, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance does not apply to this specific submission. This document details the testing of physical properties and biocompatibility of examination gloves, not an AI or imaging device.
However, I can extract the acceptance criteria and performance data for the glove product based on the provided non-clinical testing summary.
Here's the relevant information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical, for Medical Nitrile Examination Gloves)
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 - Physical Dimensions Test | |||
| Length (mm) | S: ≥220; M/L/XL: ≥230 | S: ≥220; Pass | |
| M/L/XL: ≥230; Pass | |||
| Width (mm) | S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | S: 83-88 /Pass | |
| M: 93-96/ Pass | |||
| L: 104-109/ Pass | |||
| XL: 110-116/ Pass | |||
| Thickness (mm) | Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.102-0.117/Pass | |
| Palm: 0.068-0.073/Pass | |||
| ASTM D5151 - Watertightness Test | For Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 failures out of 125 samples tested) |
| ASTM D6124 - Powder Content | Meet the requirements of ASTM D6124 |
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(107 days)
Medical 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.
The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in six sizes, which are XS, S, M, L, XL, XXL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
The provided text describes the 510(k) summary for "Medical Nitrile Examination Gloves" (K212014) and its comparison to a predicate device (K172015). This document focuses on the glove's physical and biological properties rather than a software or AI-driven medical device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in this context pertains to the performance of the physical glove based on industry standards and biocompatibility, not an algorithmic performance study typical of AI/ML medical devices.
The request asks for specific details relevant to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance). These are not applicable to the evaluation of a physical medical glove.
However, I can extract and present the information provided in the document in a format that aligns with the spirit of the request, interpreting "acceptance criteria" and "study" in the context of a physical device's non-clinical testing.
Device: Medical Nitrile Examination Gloves (K212014)
Device Type: Physical medical device (not an AI/ML algorithm)
Given that the device is a physical glove and not an AI/ML system, many of the requested points are not applicable. I will address the relevant points based on the provided document and explicitly state when a point is not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents non-clinical test results demonstrating compliance with various ASTM and ISO standards for medical gloves.
| Test Method | Purpose | Acceptance Criteria (from standard) | Reported Device Performance (Results) |
|---|---|---|---|
| Freedom from Holes - ASTM D5151-19 | Detection of holes that allow water leakage | Do not show droplet, stream or other type of water leakage (AQL 2.5 was adopted, as stated elsewhere in the document, which means a certain percentage of defects is acceptable per lot) | No leakage |
| Physical Dimension - ASTM D6319-19 | Evaluate the glove physical dimension | Length: >220 mm (XS and S sizes); >230 mm (M, L, XL and XXL sizes) | |
| Width (±10mm): XS = 70mm, S = 80mm, M = 95mm, L = 110mm, XL = 120mm, XXL = 130mm | |||
| Thickness at Finger: All Sizes ≥ 0.05 mm | |||
| Thickness at Palm: All Sizes ≥ 0.05 mm | Length: Larger than 220mm for XS and S size; Larger than 230mm for M, L, XL and XXL sizes | ||
| Width: XS: within 75±5mm, S: within 85±5mm, M: within 95±5mm, L: within 115±5mm, XL: within 125±5mm, XXL: within 135±5mm (Note: The reported results for width are slightly different than the criteria listed for predicate, but stated they meet ASTM D6319-19 requirements, which has a wider acceptable range for width compared to the predicate's stated criteria). | |||
| Thickness: Larger than 0.05mm | |||
| Physical Requirement - ASTM D412-16 | Evaluate the physical requirement (Tensile Strength, Ultimate Elongation) | Before Aging (Min): Tensile strength: 14Mpa, Ultimate elongation: 500% | |
| After Aging (Min): Tensile strength: 14Mpa, Ultimate elongation: 400% | Before aging: Larger than 14Mpa and 500% | ||
| After aging: Larger than 14Mpa and 400% | |||
| Powder Residue - ASTM D6124-06 | Evaluate the residue powder | Less than 2.0mg per glove | Less than 2.0mg |
| Skin Sensitization - ISO 10993-10 | Evaluated for the potential to cause delayed dermal contact sensitization | Non-sensitizing | No skin sensitization |
| Skin Irritation - ISO 10993-10 | Evaluated for the potential to cause skin irritation | Non-irritating | No skin irritation |
| Acute Toxicity - ISO 10993-11 | Evaluated for acute systemic toxicity | Non-acute systemic toxic | No acute toxicity |
Points Not Applicable to a Physical Device (Medical Nitrile Examination Gloves):
The following points are primarily relevant to software or AI/ML-driven medical devices and are not applicable to the evaluation of a physical product like examination gloves:
- Sample sized used for the test set and the data provenance: Not applicable. Tests are conducted on physical glove samples as per standard quality control procedures for manufacturing, not "data" test sets. The document indicates the manufacturer is in China (Jiangxi Ronglai Medical Technology Co., Ltd. - NO.666 Baixu Street, Baixu town, Jinxian County, Nanchang City, Jiangxi Province, China).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for glove performance is established by meeting specified physical and chemical properties defined by international standards (ASTM, ISO), not by expert human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against quantitative and qualitative standards.
- 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 for AI-assisted image interpretation, not physical devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. For this physical device, "ground truth" is defined by the technical specifications and testing methodologies outlined in the referenced ASTM and ISO standards.
- The sample size for the training set: Not applicable. This is for AI algorithms.
- How the ground truth for the training set was established: Not applicable. This is for AI algorithms.
Summary of the Study for Medical Nitrile Examination Gloves:
The "study" in this context refers to a series of non-clinical tests performed on the Medical Nitrile Examination Gloves to ensure they meet the established performance and safety criteria for medical examination gloves. These tests adhere to recognized international standards (ASTM D6319-19, ASTM D5151-19, ASTM D3767-03, ASTM D412-16, ASTM D6124-06, ISO 10993-10, ISO 10993-11). The results demonstrated that the device complies with these standards for properties such as freedom from holes, physical dimensions (length, width, thickness), physical requirements (tensile strength, ultimate elongation before and after aging), powder residue, and biocompatibility (skin irritation, skin sensitization, acute systemic toxicity). The conclusion drawn is that the device is as safe and effective as the legally marketed predicate device (K172015). No clinical study was performed or deemed necessary for this type of device.
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(134 days)
The Medical Nitrile Examination Gloves (Powder free, 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 is Powder Free Nitrile Examination Gloves and has different size specification and color. The proposed device is provided in non-sterile. The proposed device is made of Nitrile. The proposed device has different size specification to the predicate device, but all proposed devices are meet the specifications of ASTM D6319.
This document is a 510(k) Summary for Medical Nitrile Examination Gloves. The acceptance criteria and the study proving the device meets these criteria are detailed as follows:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by relevant ASTM and ISO standards, and the device performance is reported as complying with these standards.
| Acceptance Criteria (Standard & Requirement) | Reported Device Performance (Compliance/Result) |
|---|---|
| Physical Properties (Referencing ASTM D6319) | |
| Tensile Strength (Before Aging) - 14 MPa, min | 14 MPa, min (Applicant's device) |
| Ultimate Elongation (Before Aging) - 500% min | 500% min (Applicant's device) |
| Tensile Strength (After Aging) - 14 MPa, min | 14 MPa, min (Applicant's device) |
| Ultimate Elongation (After Aging) - 400% min | 400% min (Applicant's device) |
| Dimensions (Referencing ASTM D6319) | |
| Cuff Thickness, Palm Thickness, Finger Thickness - ≥ 0.05 mm | All proposed devices meet the specifications of ASTM D6319 (Table 1, indicates XS, S, U, M, L, XL, XXL all ≥ 0.05mm for Cuff, Palm, Finger Thickness) |
| Width - Specific values with ±10 mm tolerance (e.g., XS: 70±10, S: 80±10) | All proposed devices meet the specifications of ASTM D6319 (Table 1, indicates XS: 70±10, S: 80±10, U: 85±10, M: 95±10, L: 110±10, X-L: 120±10, XX-L: 130±10) |
| Length - Specific values (e.g., XS/S: ≥ 220 mm, U/M/L/XL/XXL: ≥ 230 mm) | All proposed devices meet the specifications of ASTM D6319 (Table 1, indicates XS/S: ≥ 220 mm, U/M/L/XL/XXL: ≥ 230 mm) |
| Freedom from Holes (Referencing ASTM D5151) | Be free from holes when tested in accordance with ASTM D5151 (Pinhole AQL 2.5) |
| Powder Content (Referencing ASTM D6124) | Less than 2 mg per glove when tested in accordance with ASTM D6124 |
| Biocompatibility (Referencing ISO 10993) | |
| Irritation (ISO 10993-10) - Not an irritant | Under the conditions of the study (ISO 10993-10), not an irritant |
| Sensitization (ISO 10993-10) - Not a sensitizer | Under conditions of the study (ISO 10993-10), not a sensitizer |
| Acute Systemic Toxicity (ISO 10993-11) - No mortality or systemic toxicity | Under the condition of the study (ISO 10993-11), there is no mortality or evidence of systemic toxicity |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for physical properties, number of animals for biocompatibility tests). However, it implies that the tests were conducted according to the methodologies prescribed by the referenced standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-11), which would include sample size requirements.
The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature of the data. However, the manufacturer is Jiangxi Hongda Medical Equipment Group Ltd. from China, and the testing results seem to be specific to their manufactured gloves. These appear to be prospective studies conducted specifically for this 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable to this type of device submission. The "ground truth" for medical gloves is established through objective physical, chemical, and biological testing against recognized international standards (ASTM and ISO), not through expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations are based on objective laboratory testing against predefined criteria in standards, not subjective assessments requiring expert 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
This information is not applicable. This is a submission for medical gloves, a physical device, and does not involve AI software or human readers for diagnostic interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a submission for medical gloves, a physical device, and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device is based on objective measurements and laboratory testing results compared against the specifications defined in recognized international standards:
- ASTM D6319-19 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151-19 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124-17 (Standard Test Method for Residual Powder on Medical Gloves)
- ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- ISO 10993-11:2017 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical product (medical gloves), not an AI algorithm, and therefore does not have a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this device.
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