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510(k) Data Aggregation
(76 days)
The Disposable Nitrile Powder-Free Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Disposable Nitrile Powder-Free Examination Gloves. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
Based on the provided text, the device in question is "Disposable Nitrile Powder-Free Examination Gloves," which are Class I medical devices used to prevent contamination between patients and examiners. The document describes non-clinical performance testing rather than a study involving human subjects or AI, as would be typical for software or imaging devices.
Therefore, many of the requested categories for AI-based device studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this premarket notification for examination gloves.
Here's the relevant information based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards for examination gloves.
Table of Acceptance Criteria and Reported Device Performance for Disposable Nitrile Powder-Free Examination Gloves:
| Test | Methodology / Standard | Purpose | Acceptance Criteria | Reported Performance/Results |
|---|---|---|---|---|
| Biocompatibility | ||||
| Irritation & Skin Sensitization | ISO 10993-10:2010 | Assess possible contact hazards from chemicals, which may produce skin and mucosal irritation, eye irritation or skin sensitization. | Skin Sensitization Test: Provided grades less than 1, otherwise sensitization.Skin Irritation Test: Primary irritation index: 0-0.4 (Negligible), 0.5-1.9 (Slight), 2-4.9 (Moderate), 5-8 (Severe). | Skin Sensitization Test: All grades are 0. All animals survived with no abnormal signs observed.Skin Irritation Test: Primary irritation index is 0. Response categorized as negligible. |
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Assess the in vitro cytotoxicity of medical devices. | Viability reduced to <70% of the blank indicates cytotoxic potential. | Viab.% of 100% test article extract is 21.0%. The proposed device has potential toxicity to L-929 in the MTT method. (Note: Despite this, it was cleared, likely due to subsequent systemic toxicity testing and the nature of glove contact.) |
| Systemic Toxicity | ISO 10993-11:2017 | Evaluate the potential for medical device materials to cause adverse systemic reactions. | Within 72 h, if the toxicosis response of testing group is not greater than that of control group, the testing sample is acceptable. | No evidence of systemic toxicity from the extract. |
| Physical/Performance Properties | ||||
| Residual Powder on Medical Gloves | ASTM D6124-06 (Reapproved 2017) | Determine the amount of residual powder found on medical gloves (for powder-free distinction). | Powder residue limit of 2.0 mg. | 0.09-0.11 mg/glove. (Meets criterion as it is well below 2.0mg) |
| Detection of Holes in Medical Gloves | ASTM D5151-06 (Reapproved 2015) | Cover the detection of holes in medical gloves. | Sample number: 125 gloves. AQL (Acceptable Quality Limit) = 2.5. Criterion ≤7 gloves for water leakage. | No glove water leakage found. |
| Specifications for Nitrile Exam Gloves | ASTM D6319-10 (Reapproved 2015) | Covers certain requirements for nitrile rubber gloves used in medical examinations and procedures. | Dimensions:- S: width 80±10mm, length ≥220 mm- M: width 95±10mm, length ≥230 mm- L: width 110±10mm, length ≥230 mm- XL: width 120±10mm, length ≥230 mmThickness: Finger ≥0.05 mm, Palm ≥0.05 mmPhysical properties:- Before aging: Tensile strength ≥14MPa, Ultimate Elongation ≥500%- After Accelerated Aging: Tensile strength ≥14MPa, Ultimate Elongation ≥400% | Dimensions (across multiple lots):- S: width 82-86 mm, length 245-255 mm- M: width 91-96 mm, length 245-256 mm- L: width 101-110 mm, length 252-261 mm- XL: width 111-120 mm, length 250-262 mm (All reported dimensions meet or exceed the min/range, considering tolerance analyses further down the document).Thickness (across multiple lots): Finger 0.11-0.12 mm, Palm 0.07-0.08 mm (All meet or exceed the minimum).Physical properties (across multiple lots):- Before aging: Tensile strength 15.2-24.4 MPa, Ultimate Elongation 525.655% - 798.544% (All meet or exceed required minimums).- After Accelerated Aging: Tensile strength 14.0-18.7 MPa, Ultimate Elongation 578.552% - 745.388% (All meet or exceed required minimums). |
Study Details (Non-Clinical Performance Testing):
This document describes non-clinical performance testing of a physical device (examination gloves), not a study of an AI algorithm or human reader performance. Therefore, most of the requested fields are not applicable.
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Sample size used for the test set and the data provenance:
- Freedom from Holes: 125 gloves. No specific country of origin is mentioned for the test samples; it's implied they are samples of the manufactured gloves. The testing is prospective as it's part of the product characterization for market submission.
- Other tests (Biocompatibility, Physical properties): Sample sizes are not explicitly stated for individual tests but are implied to be sufficient for compliance with the respective standards (e.g., ISO, ASTM). The data provenance is testing conducted by the manufacturer (Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.) or its contracted labs.
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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. Ground truth for device performance is established by standardized test methodologies and their objective measurements, not by expert consensus or interpretations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a human interpretation study.
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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 device is not an AI-assisted diagnostic tool.
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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, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is defined by adherence to established international and national standards (ASTM, ISO) for material properties, dimensions, and biological safety. This is based on objective measurements and laboratory testing results.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning model. The manufacturing process is implicitly "trained" over time to produce consistent results that meet standards.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.
In summary, this FDA 510(k) submission for examination gloves demonstrates substantial equivalence to a predicate device, primarily through non-clinical laboratory testing that shows compliance with relevant performance and safety standards. The regulatory pathway is not driven by AI model validation or human reader performance studies.
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(156 days)
The Disposable Nitrile Examination Gloves 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. The proposed device is blue. The design of proposed device is addressing the standards as ASTM D6124,ASTM D5151, and ASTM D6319. The proposed device is non-sterile.
This document is a 510(k) Premarket Notification for "Disposable Nitrile Examination Gloves" (K203436) by Shandong Zhushi Pharmaceutical Group Co., Ltd. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (K171422).
The 510(k) submission primarily relies on non-clinical performance testing to demonstrate safety and effectiveness.
Here's an analysis based on your request, focusing on acceptance criteria and study proving device meets criteria:
1. A table of acceptance criteria and the reported device performance
| No. | Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|---|
| 1 | ISO 10993-10:2010 (Skin Sensitization Test) | Assess possible contact hazards from chemicals, specifically skin sensitization. | Grades less than 1. | All grades are 0. All animals were survived and no abnormal signs were observed during the study. (Pass) |
| 2 | ISO 10993-10:2010 (Skin Irritation Test) | Assess possible contact hazards from chemicals, specifically skin irritation. | Primary irritation index is 0-0.4 for "Negligible" response category. | The primary irritation index is 0. The response of the proposed device was categorized as negligible under the test condition. (Pass) |
| 3 | ISO 10993-5:2009 (In Vitro Cytotoxicity) | Assess the in vitro cytotoxicity of medical devices. | Viability is not reduced to <70% of the blank. | Viab.% of 100% test article extract is 70.9%. It means the proposed device has no potential toxicity to L-929 in the MTT method. (Pass) |
| 4 | ASTM D6124-06 (Reapproved 2017), Standard Test Method for Residual Powder on Medical Gloves | Determine the amount of residual powder found on medical gloves. | Powder residue limit of 2.0 mg. | 0.02 mg (Pass, well below the limit) |
| 5 | ASTM D5151-06 (Reapproved 2015), Standard Test Method for Detection of Holes in Medical Gloves. | Covers the detection of holes in medical gloves. | Samples number: 125 gloves; AQL: 2.5 (ISO 2859); Criterion ≤7 gloves for water leakage. | No glove water leakage found. (Pass) |
| 6 | ASTM D6319-10 (Reapproved 2015), Standard Specification For Nitrile Examination Gloves For Medical Application. | Covers certain requirements for nitrile rubber gloves used in medical examinations and diagnostic/therapeutic procedures. | Dimensions: - XS: width 70±10mm, length ≥220 mm - S: width 80±10mm, length ≥220 mm - M: width 95±10mm, length ≥230 mm - L: width 110±10mm, length ≥220 mm - XL: width 75±6mm, length ≥220 mm - Thickness (Finger & Palm): ≥0.05 mm Physical Properties (Before Aging): - Tensile strength ≥14MPa - Ultimate Elongation ≥500% Physical Properties (After Accelerated Aging): - Tensile strength ≥14MPa - Ultimate Elongation ≥400% | Dimensions: - XS: Avg width 71.38 mm, Avg Length 221.25 mm. Avg Finger thickness 0.05 mm, Avg Palm thickness 0.07 mm. - S: Avg width 82.63 mm, Avg Length 221.12 mm. Avg Finger thickness 0.055 mm, Avg Palm thickness 0.066 mm. - M: Avg width 93.4 mm, Avg Length 232.13 mm. Avg Finger thickness 0.053 mm, Avg Palm thickness 0.079 mm. - L: Avg width 102.75mm, Avg Length 231.4 mm. Avg Finger thickness 0.054 mm, Avg Palm thickness 0.076 mm. - XL: Avg width 115.4mm, Avg Length 231.7 mm. Avg Finger thickness ≥0.054 mm, Avg Palm thickness ≥0.08 mm. Physical Properties (Before Aging): - Avg Tensile strength 25.4 MPa - Avg Ultimate Elongation ≥608% Physical Properties (After Accelerated Aging): - Avg Tensile strength 25MPa - Avg Ultimate Elongation 505% (All dimensions and physical properties meet or exceed the specified criteria. Sterility is N.A. (not applicable as it's non-sterile), and Freedom from Holes and Powder-free Residue refer to tests #5 and #4 respectively, which passed). |
2. Sample sizes used for the test set and the data provenance
- ISO 10993-10 (Skin Sensitization & Irritation): The document doesn't explicitly state the exact sample size (number of animals) used for the biological evaluation tests beyond stating "All animals were survived" and "the primary irritation index is 0". Typically, these standards specify minimum animal counts.
- ISO 10993-5 (In Vitro Cytotoxicity): "Viab.% of 100% test article extract is 70.9%". This refers to cell culture tests (L-929 cells). The exact number of replicates or passages is not specified.
- ASTM D5151 (Freedom from Holes): Sample size: 125 gloves.
- ASTM D6124 (Residual Powder) & ASTM D6319 (Dimensions, Physical Properties): The sample sizes for these physical and chemical tests are not explicitly stated in the document, but they are typically governed by the respective ASTM standards (e.g., a certain number of gloves per batch/size for dimensional checks or tensile strength tests).
- Data Provenance: The document does not explicitly state the country of origin for the test data generation. However, the submitter is "Shandong Zhushi Pharmaceutical Group Co., Ltd" from "Shandong, China" and the designated submission correspondent is in "Shanghai, China." Given this information, it is highly likely that the testing was conducted in China. The data would be considered prospective as it was generated specifically for this 510(k) submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as this is a submission for a Class I medical device (Disposable Nitrile Examination Gloves), which primarily relies on engineering and material performance standards. It is not an AI/imaging device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods are relevant for studies involving human interpretation of data, typically in diagnostic imaging or clinical trials, not for physical performance testing of gloves.
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 section is not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of these gloves is established through direct physical, chemical, and biological testing against established scientific standards (ISO and ASTM). For example:
- Physical Properties (Tensile Strength, Elongation, Dimensions): The ground truth is the measured physical characteristic of the glove compared against the specified numerical limits in ASTM D6319.
- Freedom from Holes: The ground truth is the absence or presence of water leakage as per ASTM D5151.
- Residual Powder: The ground truth is the measured powder amount compared against the limit in ASTM D6124.
- Biocompatibility (Irritation, Sensitization, Cytotoxicity): The ground truth is the biological response observed in the in-vitro or in-vivo (animal) models according to ISO 10993 standards, compared against defined non-toxic or non-irritant criteria.
8. The sample size for the training set
This section is not applicable. There is no "training set" for this device as it is not a machine learning or AI-based product.
9. How the ground truth for the training set was established
This section is not applicable. As there is no training set.
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(74 days)
The Disposable Nitrile Gloves are intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
The provided document is a 510(k) Premarket Notification summary for Disposable Nitrile Gloves (K210276). It is not for an AI/ML medical device, but rather for a physical medical device (gloves). Therefore, the information requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) is not applicable to this document.
The document discusses the substantial equivalence of the Disposable Nitrile Gloves to a predicate device (K171422) based on performance testing and adherence to recognized standards.
Here's an attempt to interpret the provided content in the context of your request, while acknowledging that it doesn't fit the typical AI/ML device evaluation structure:
1. A table of acceptance criteria and the reported device performance:
The document outlines comparisons between the subject device (K210276) and the predicate device (K171422), effectively serving as the acceptance criteria for substantial equivalence. The reported device performance is demonstrated by its compliance with the listed standards.
| Acceptance Criteria (Common to Subject & Predicate) | Reported Device Performance (K210276) |
|---|---|
| General Characteristics | |
| Product Code: LZA | LZA |
| Regulation No: 21CFR880.6250 | 21CFR880.6250 |
| Class: I | I |
| Intended Use: Medical purposes; worn on examiner's hands to prevent contamination between patient and examiner. | Same |
| Powdered/Powered free: Powdered free | Powdered free |
| Design Feature: Ambidextrous | Ambidextrous |
| Labeling Information: Single-use indication, powder free, device color, device name, glove size and quantity | Single-use indication, powder free, device color, device name, glove size and quantity, Nitrile Glove Powder Free Blue, Non-Sterile |
| Dimensions (Compliance with ASTM D6319-19) | |
| Length, mm: 230 min (for predicate) | 230 mm (S, M, L, XL) with ±10 tolerance |
| Width, mm: 75, 85, 95, 105, 115 (for predicate) with ±5 tolerance | 85 (S), 95 (M), 110 (L), 115 (XL) with ±10 tolerance |
| Thickness, mm: Finger 0.05 min | 0.05 min |
| Thickness, mm: Palm 0.05 min | 0.05 min |
| Physical Properties | |
| Before Aging: Tensile Strength 14MPa, min | 14MPa, min |
| Before Aging: Ultimate Elongation 500% min | 500% min |
| After Aging: Tensile Strength 14MPa, min | 14MPa, min |
| After Aging: Ultimate Elongation 400%min | 400%min |
| Freedom from Holes: Comply with ASTM D6319, be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Comply with ASTM D6319, be free from holes when tested in accordance with ASTM D5151 AQL=2.5 |
| Powder Content: Meet requirements of ASTM D6124 | 0.01 mg per glove |
| Safety/Biocompatibility (Compliance with ISO 10993) | |
| Material: Nitrile | Nitrile |
| Irritation: Not an irritant (comply with ISO10993-10) | Not an irritant (under the conditions of the study) |
| Sensitization: Not a sensitizer (comply with ISO10993-10) | Not a sensitizer (under conditions of the study) |
| Cytotoxicity: Device extract is not cytotoxic (comply with ISO10993-5) | Device extract is not cytotoxic (under conditions of the study) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each test conducted (e.g., number of gloves tested for tensile strength, holes, etc.). It only states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The standards themselves (e.g., ASTM D6319, ASTM D5151) would define the required sample sizes for their respective tests, but these details are not present in this summary.
- Data Provenance: The tests were non-clinical performance tests, usually performed in a lab setting by the manufacturer or a contracted lab. The manufacturer is Fujian Ercon Medical Management Co., Ltd. in China. The provenance is internal testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is not a study requiring expert readers or ground truth establishment in the context of interpreting medical images or data. The "ground truth" for these tests is defined by the technical specifications and standards (e.g., a hole is present or absent according to ASTM D5151 criteria).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is not an interpretive/diagnostic study, no adjudication method for human readers is relevant. The tests are laboratory measurements.
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 medical device (gloves), not an AI/ML diagnostic aid. There were no human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is objective measurements and compliance with industry standards (e.g., ASTM D6319-19 for glove specifications, ASTM D5151-19 for holes, ISO 10993 for biocompatibility). It is based on pre-defined engineering specifications and test protocols.
8. The sample size for the training set:
- Not Applicable. This is not an AI/ML device; there is no 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.
In summary, the provided document details the regulatory submission for a physical medical device, not an AI/ML diagnostic tool. Therefore, many of the questions related to AI/ML study design are not applicable. The device's acceptance is based on non-clinical performance testing confirming its compliance with recognized standards and substantial equivalence to a legally marketed predicate device.
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