Search Results
Found 186 results
510(k) Data Aggregation
(87 days)
Powder-Free Latex examination gloves
The powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger or finger to prevent contamination between patient and examiner.
The proposed device is Powder-Free Latex Examination Gloves. The gloves are single use and are provided non-sterile. The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The proposed device is provided with natural color. The device is available in two lengths, each with six sizes, extra-small (XS), small (S), medium (M), large (L) and extra-large (XL), and extra extra-large (XXL). The device is non-sterile.
The provided document is a 510(k) premarket notification for Powder-Free Latex Examination Gloves. This type of device is classified as a Class I medical device (21 CFR 880.6250 - Non-Powdered Patient Examination Glove).
The information requested regarding acceptance criteria and a study proving the device meets those criteria typically applies to more complex devices, especially those involving AI/ML components or requiring clinical performance studies to establish safety and effectiveness.
For this specific device (examination gloves), the "study" that proves it meets acceptance criteria is primarily non-clinical testing against established ASTM and ISO standards for physical properties, integrity, and biocompatibility. Clinical studies are explicitly stated as not included in this submission.
Therefore, many of the requested points are not applicable in the context of this 510(k) submission for examination gloves. I will address the applicable points and explicitly state where information is not present or not relevant to this type of device.
Acceptance Criteria and Device Performance for Powder-Free Latex Examination Gloves (K222612)
For this device, the "acceptance criteria" are defined by compliance with recognized consensus standards (ASTM and ISO). The "study" proving acceptance is the non-clinical testing performed against these standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria (from Standards) | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM D3578-19: Tensile properties (unaged) | Adequate tensile strength | Greater than 18 MPa | Pass |
| Adequate elasticity at 500% elongation | Stress less than 5.5 MPa | Pass | |
| Adequate ultimate elongation | Greater than 650% | Pass | |
| ASTM D3578-19: Tensile properties (after aging) | Adequate tensile strength after aging | Greater than 14 MPa | Pass |
| Adequate ultimate elongation after aging | Greater than 500% | Pass | |
| ASTM D5151-19: Detection of Holes in Medical Gloves | Demonstrate glove integrity | AQL 2.5 | Pass |
| ASTM D6124-06(2017): Residual Powder on Medical Gloves | Demonstrate low powder | Less than 2.0 mg/glove | Pass |
| ASTM D5712-15: Analysis of Aqueous Extractable Protein in Natural Rubber | Demonstrate low level of extractable protein | Not more than 200 µg/dm² | Pass |
| ISO 10993-10:2010: Tests For Irritation And Skin Sensitization | Demonstrate low potential for skin irritation | Not an irritant (under test conditions) | Pass |
| Demonstrate low potential for skin sensitizer | Not a sensitizer (under test conditions) | Pass | |
| ISO 10993-11:2017: Tests for Systemic Toxicity | Demonstrate low acute systemic toxicity | No acute systemic toxicity (under test conditions) | Pass |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes (e.g., number of gloves) used for each specific non-clinical test. These sample sizes would be specified within the methodologies of the referenced ASTM and ISO standards.
- Data Provenance: The testing was conducted by or on behalf of Guangdong Kingfa Sci.&Tech. Co., Ltd., based in China. The data is from non-clinical laboratory testing, not human subjects, and is inherently retrospective as it was conducted prior to this submission.
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. For this type of device, "ground truth" is established by the physical and chemical properties measured against the objective metrics defined in the ASTM and ISO standards, using calibrated equipment and standard laboratory procedures. It does not involve human expert interpretation or consensus comparable to image-based medical device studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for human-interpretable data where multiple readers might have differing opinions (e.g., medical image interpretation). This submission relies on objective laboratory test results.
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. MRMC studies are used for evaluating human performance, typically involving AI assistance in diagnostic tasks. This device is an examination glove, not an AI-enabled diagnostic tool. No clinical study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not have an "algorithm" or standalone AI component. Its performance is measured directly through physical and chemical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device is based on objective measurements against established engineering and biocompatibility standards. For example, tensile strength measured in MPa, hole detection based on water leak AQL, residual powder in mg/glove, protein content in µg/dm², and ISO 10993 series for biological responses (irritation, sensitization, systemic toxicity) are the "ground truth" metrics.
8. The sample size for the training set:
- Not applicable. This is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable due to the absence of a training set.
Ask a specific question about this device
(142 days)
Non Sterile Powder Free Latex Examination Glove
Non Sterile Powder Free Latex Examination Gloves is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Non Sterile Powder Free Latex Examination Gloves
The provided document is a 510(k) clearance letter from the FDA for "Non Sterile Powder Free Latex Examination Gloves." It certifies that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI/software performance as requested in your prompt.
The questions you've asked are typically relevant to the evaluation of AI/ML-driven medical devices (e.g., for diagnostic imaging), where performance metrics like sensitivity, specificity, or AUC are critical, and detailed study methodologies are required to demonstrate clinical validity.
This document pertains to a Class I medical device (non-powdered patient examination glove) which is a physical product, not a software or AI-based device. Therefore, the type of information you are seeking (AI performance, MRMC studies, ground truth establishment for algorithms, etc.) is not applicable and not present in this document.
Ask a specific question about this device
(95 days)
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination
Gloves
Powder Free Nitrile Examination Gloves, 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 Examination Gloves, Black 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 Examination Gloves, White 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 Powder Free Nitrile Examination Gloves, Violet 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.
The Powder Free Latex 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.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for examination gloves. It does not contain information about an AI/ML powered medical device, a clinical study with acceptance criteria and device performance. Therefore, I cannot extract the requested information.
The document is for "Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves," which are Class I devices (non-powered patient examination gloves) and do not involve AI. The FDA letter confirms the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for this type of device.
To provide the requested information, the input text would need to describe a medical device that uses AI/ML and include details about its performance studies.
Ask a specific question about this device
(455 days)
Powder Free Latex Examination Glove, Non-Sterile
A patient examination glove is a disposable device made of natural rubber latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The powder free latex examination glove is manufactured from natural rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand. The physical properties of glove i.e. tensile strength meet ASTM standard D3578. Device is intended for single use and nonsterile. The powder free latex examination glove, non-sterile is supplied in the following sizes: XS, S, M, L and XL. This qlove is natural in color is added) and powder free.
The provided text is a 510(k) premarket notification for a medical device: "Natural Rubber Latex Examination Glove, Non-Sterile, Powder Free." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than clinical efficacy studies often associated with AI/ML devices. Therefore, the questions related to AI/ML device testing (e.g., ground truth establishment by experts, MRMC studies, training set details) are not applicable to this submission.
However, I can extract the acceptance criteria and performance data for the physical characteristics of the examination gloves, which are the relevant "performance" metrics for this device.
Here's the information based on the provided text, focusing on the non-clinical testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|---|
| Physical Properties (Before Aging) | ASTM D412 (Tension) | |||
| Tensile Strength | ASTM D412 | Min 18.0 MPa | XS: 24.40 MPa, S: 24.56 MPa, M: 27.18 MPa, L: 26.51 MPa, XL: 26.11 MPa | Pass |
| Ultimate Elongation | ASTM D412 | Min 650% | XS: 792 %, S: 808 %, M: 817 %, L: 811 %, XL: 783 % | Pass |
| Stress at 500% Elongation | ASTM D412 | Max. 5.5 MPa | XS: 4.77 MPa, S: 5.11 MPa, M: 4.55 MPa, L: 4.85 MPa, XL: 5.22 MPa | Pass |
| Physical Properties (After Aging) | ASTM D412 (Tension) | |||
| Tensile Strength | ASTM D412 | Min 14.0 MPa | XS: 25.59 MPa, S: 22.37 MPa, M: 27.16 MPa, L: 25.95 MPa, XL: 26.67 MPa | Pass |
| Ultimate Elongation | ASTM D412 | Min 500% | XS: 802 %, S: 723 %, M: 809 %, L: 829 %, XL: 785 % | Pass |
| Dimension | ASTM D3767 (Rubber Measurement of Dimensions) | |||
| Length | ASTM D3767 | Min 240 mm (for all sizes) | XS: 243 mm, S: 243 mm, M: 243 mm, L: 243 mm, XL: 243 mm | Pass |
| Width | ASTM D3767 | XS: Max 80 mm, S: Min 80 ± 10 mm, M: Min 95 ± 10 mm, L: Min 110 ± 10 mm, XL: Min 110 mm | XS: 78 mm, S: 84 mm, M: 95 mm, L: 106 mm, XL: 116 mm | Pass |
| Thickness (Finger) | ASTM D3767 | Min 0.11 mm | XS: 0.14 mm, S: 0.14 mm, M: 0.15 mm, L: 0.15 mm, XL: 0.16 mm | Pass |
| Thickness (Palm) | ASTM D3767 | Min 0.09 mm | XS: 0.12 mm, S: 0.12 mm, M: 0.12 mm, L: 0.12 mm, XL: 0.13 mm | Pass |
| Watertight | ASTM D5151 (Detection of Holes in Medical Gloves) | Inspection Level 1, AQL 1.0 (Acceptance no. 5 for 200 pcs, Acceptance no. 10 for 500 pcs) | XS: Found 0 leaks (Sample 200), S: Found 1 leak (Sample 500), M: Found 3 leaks (Sample 500), L: Found 3 leaks (Sample 500), XL: Found 3 leaks (Sample 200) | Pass |
| Residual Powder | ASTM D6124 (Residual Powder on Medical Gloves) | Powder residue limit of 2.0 mg per glove | XS: 0.2 mg, S: 0.5 mg, M: 0.1 mg, L: 0.1 mg, XL: 0.2 mg | Pass |
| Extractable Protein Content | ASTM D5712-99 (Protein in Natural Rubber) | 200 µg/dm² Max | Less than 50 µg/dm² | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Physical Properties: Data is provided for each size (XS, S, M, L, XL). The specific sample size for each test (e.g., number of gloves tested for tensile strength) is not explicitly stated, but the results represent the performance across these sizes.
- Dimension: Data is provided for each size (XS, S, M, L, XL).
- Watertight:
- XS & XL: Sample size 200 pcs each.
- S, M, L: Sample size 500 pcs each.
- Data Provenance: The document does not specify the country of origin where the testing was conducted or if it was retrospective/prospective. It's non-clinical lab testing.
- Residual Powder: Sample size: 5 pcs.
- Extractable Protein Content: Sample size: 3 pcs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an examination glove, and its performance is evaluated through standardized physical, chemical, and biocompatibility tests, not clinical expert review of images or medical data. The "ground truth" is defined by the parameters of the ASTM standards and the test results.
4. Adjudication Method for the Test Set
Not applicable. The tests performed are objective, quantitative measurements against predefined standards, not subjective assessments requiring multiple reviewers or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This is not an AI/ML device or a diagnostic device that would typically undergo MRMC studies.
6. If a Standalone (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
The ground truth is established by international and national standards (e.g., ASTM D3578, ASTM D412, ASTM D3767, ASTM D5151, ASTM D6124, ASTM D5712-99, ISO 10993 series) for physical properties, biocompatibility, and manufacturing quality of medical gloves. These standards define the measurable acceptance criteria.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Summary of Study Type:
The document describes non-clinical performance testing against established industry standards (ASTM, ISO) to demonstrate that the Natural Rubber Latex Examination Glove meets all relevant safety and performance requirements and is substantially equivalent to a legally marketed predicate device (K202377). It's a bench testing/laboratory study based on adherence to quantitative standards rather than a clinical trial or AI/ML model validation study.
Ask a specific question about this device
(365 days)
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
CAUTION: Safe use of this glove by on or latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions.
Non-Sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth for a medical device that would involve AI, human readers, or specific performance metrics like sensitivity or specificity.
The document is a 510(k) clearance letter from the FDA for Non-sterile, Powder-Free Latex Examination Gloves. This type of device does not typically involve complex performance studies with AI, human interpretation, or ground truth establishment in the way described in your request. The clearance is based on substantial equivalence to legally marketed predicate devices, and the "Indications for Use" section simply describes the intended use of the gloves for preventing contamination.
Therefore, I cannot provide the requested information as it is not present in the given text.
Ask a specific question about this device
(78 days)
Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination
Gloves
Ask a specific question about this device
(259 days)
Non-sterile, Powder-Free Latex Examination Glove
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove contains 50 micrograms or less of total water extractable protein per gram.
CAUTION: Safe use of this glove by or on latex sensitized individuals has not been established. CAUTION: This product contains natural rubber latex which may cause allergic reactions
Non-sterile, Powder-Free Latex Examination Glove
This document is a 510(k) premarket notification decision letter from the FDA for a Non-sterile, Powder-Free Latex Examination Glove. It is not for a medical device that utilizes AI or algorithmic performance, therefore, the requested information regarding acceptance criteria, study details, ground truth establishment, and expert involvement is not applicable to this document.
The document discusses substantial equivalence to predicate devices for a physical product (gloves) and outlines regulatory requirements for such products, not performance metrics for an AI/algorithm-based device.
Ask a specific question about this device
(85 days)
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein
Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Biodegradable Powder Free Latex Examination Gloves" and discusses regulatory compliance, not performance studies of a specific AI device. Therefore, I cannot generate the requested table and study details.
Ask a specific question about this device
(251 days)
POWDER FREE LATEX EXAMINATION GLOVE
A patient examination glove 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 Latex Examination Gloves meets all the current specifications listed under the ASTM Specification D3578-05, Standard Specification for Rubber Examination Gloves. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
This document is a 510(k) premarket notification for a medical device: "Powder Free Latex Examination Glove." It's not a study proving an AI/computer-aided device meets acceptance criteria, but rather a regulatory submission demonstrating substantial equivalence to a predicate device based on non-clinical performance data for a physical product (a glove).
Therefore, I cannot extract the information required to populate a table for acceptance criteria of an AI device, nor provide details about a study that proves an AI device meets acceptance criteria. The document does not describe:
- AI device performance metrics: The criteria and results are for physical glove characteristics (e.g., tensile strength, freedom of holes, dimensions).
- Sample size for test set or data provenance for an AI algorithm.
- Number of experts and their qualifications for establishing ground truth related to AI.
- Adjudication method for AI ground truth.
- MRMC study or effect size of AI assistance on human readers.
- Standalone AI performance.
- Type of ground truth (e.g., pathology, outcomes data) for medical images.
- Training set size or ground truth establishment for an AI model.
The document states:
- "8.0 Assessment of Clinical Performance Data: Not applicable - Clinical data is not needed." This further indicates the absence of a study similar to what would be done for an AI/CADe device.
- "7.0 Non-Clinical Performance Data: The performance test data of the non-clinical tests is reported in the table above." This refers to the physical and chemical properties of the glove.
In summary, this document is entirely unrelated to the type of AI/CADe device evaluation you're asking about. It's a regulatory submission for a simple Class I physical medical device (examination gloves).
Ask a specific question about this device
(163 days)
POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATED
A patient examination glove 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 Latex Examination Glove, Polymer Coated
The provided text is a 510(k) clearance letter from the FDA for a Powder Free Latex Examination Glove, Polymer Coated. This document does not contain information about acceptance criteria or a study proving that an AI/ML-enabled device meets those criteria.
The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is specific to the evaluation of AI/ML performance in a medical device context. This document, however, pertains to a physical medical device (examination gloves) and its substantial equivalence to a predicate device based on its intended use and general controls.
Therefore, I cannot provide the requested information based on the input text.
Ask a specific question about this device
Page 1 of 19