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510(k) Data Aggregation
(146 days)
Powder free Surgeon's glove is a sterile powder free medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Class I Powder free Surgical Glove 79KGO that meets all 'the requirements of ASTM D3577.
This document is a 510(k) summary for a Sterile Latex Surgeon's Glove (Powder Free). It focuses on demonstrating substantial equivalence to a predicate device by meeting ASTM D3577 and FDA requirements.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3577 / FDA Requirement) | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Dimensions | |||
| Length (5 ½ - 9) | 245 mm minimum (for 5 ½), 265 mm minimum (for 6-9) | 270-272 mm (all sizes) | Yes |
| Width (5 ½) | 70 +/- 6 mm | 68 mm | Yes |
| Width (6) | 76 +/- 6 mm | 73 mm | Yes |
| Width (6 ½) | 83 +/- 6 mm | 79 mm | Yes |
| Width (7) | 99 +/- 6 mm | 87 mm | Yes |
| Width (7 ½) | 95 +/- 6 mm | 92 mm | Yes |
| Width (8) | 105 +/- 6 mm | 103 mm | Yes |
| Width (8 ½) | 108 +/- 6 mm | 106 mm | Yes |
| Width (9) | 114 +/- 6 mm | 112 mm | Yes |
| Thickness | 0.1 mm minimum (cuff, palm, fingertip) | 0.12, 0.16, 0.19 mm (cuff, palm, fingertip) | Yes |
| Physical Properties (Before Ageing) | |||
| Tensile Strength | 24 mpa | 27 mpa | Yes |
| Elongation at break % | 750% | 850% | Yes |
| Modulus at 500% elongation | 5.5 mpa (max) | 3 mpa | Yes |
| Physical Properties (After Ageing) | |||
| Tensile Strength | 18 mpa min | 20 mpa | Yes |
| Elongation at break % | 560% min | 750% | Yes |
| Performance Requirements | |||
| Sterility | As per USP* | As per IP* | Yes (equivalent standard) |
| Freedom from Holes | 1.5 AQL (S4) | 1.5 AQL (S4) | Yes |
| Dimension | 4 AQL (S2) | 4 AQL (S2) | Yes |
| Physical Property | 4 AQL (S2) | 4 AQL (S2) | Yes |
| Additional Properties | |||
| Powder Content | 2 mg/glove max | Nil Powder (1 +/- 1 mg/glove) | Yes |
| Protein Content | 200 ppm max | 80 +/- 20 ppm | Yes |
| Moisture Content | N/A (implied by "value fixed", "0.8% max") | 0.8% max | Yes |
| Biocompatibility | Biologically Compatible | Biologically Compatible | Yes |
Note: IP (Indian Pharmacopeia) is considered equivalent to USP (United States Pharmacopeia) for sterility in this context.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for length, width, tensile strength, etc.). However, it refers to general AQL (Acceptance Quality Limit) levels (S2 and S4) for performance requirements like freedom from holes, dimensions, and physical properties. These AQL levels imply a sampling plan, but the exact number of units sampled is not provided.
The data provenance is for gloves manufactured by Brightway Gloves Pvt. Ltd. in Tamil Nadu, India. This is retrospective data, as it describes the performance of already manufactured gloves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document does not involve a test set requiring expert ground truth establishment in the traditional sense (e.g., image interpretation). Instead, the "ground truth" for compliance testing is established by recognized standards: ASTM D3577 (Standard Specification for Rubber Surgical Gloves) and FDA requirements/USP/IP standards. Therefore, no specific number of human experts for ground truth is applicable here. The experts involved are those who developed and maintain these national and international standards.
4. Adjudication Method for the Test Set
Not applicable. The evaluation is based on direct measurement and comparison against defined standard specifications, not on subjective expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a performance specification and substantial equivalence study for a medical device (surgical gloves), not an AI algorithm requiring MRMC studies.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This study is about the physical and chemical properties of a medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth used is established industry and regulatory standards:
- ASTM D3577 requirements for latex surgeon's gloves.
- FDA requirements for attributes like pinholes and protein content.
- USP (United States Pharmacopeia) or IP (Indian Pharmacopeia) for sterility.
8. Sample Size for the Training Set
Not applicable. This device is manufactured using a process, and its performance is evaluated against specifications, not "trained" in the way an AI model is trained.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device. The manufacturing process is designed to meet the established standards and is subject to quality control to ensure consistency.
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(138 days)
Surgeon's glove (powdered) is a sterile medical device made of natural latex intended to be worn by operating room personnel to protect a surgical wound from contamination and is powdered with absorbable dusting powder USP corn starch as the donning lubricant.
Class I Powdered Surgical Glove 79KGO that meets all the requirements of ASTM D3577.
This is an analysis of a 510(k) summary for a medical device, specifically powdered surgeon's gloves. The document primarily focuses on demonstrating substantial equivalence to a predicate device through meeting established performance standards.
Here's the breakdown of acceptance criteria and device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3577 & other standards) | Reported Device Performance (Brightway Gloves Pvt. Ltd.) | Meets Criteria? |
|---|---|---|---|
| Dimensions | |||
| Length (5 ½) | 245 mm minimum | 270-272 mm | Yes |
| Length (6 to 9) | 265 mm minimum | 270-272 mm | Yes |
| Width (5 ½) | 70 +/- 6 mm | 68 mm | Yes (Within range) |
| Width (6) | 76 +/- 6 mm | 73 mm | Yes (Within range) |
| Width (6 ½) | 83 +/- 6 mm | 79 mm | Yes (Within range) |
| Width (7) | 99 +/- 6 mm | 87 mm | Yes (Within range) |
| Width (7 ½) | 95 +/- 6 mm | 92 mm | Yes (Within range) |
| Width (8) | 105 +/- 6 mm | 103 mm | Yes (Within range) |
| Width (8 ½) | 108 +/- 6 mm | 106 mm | Yes (Within range) |
| Width (9) | 114 +/- 6 mm | 112 mm | Yes (Within range) |
| Thickness (Cuff, Palm, Fingertip) | 0.1 mm minimum | 0.12 mm (cuff), 0.16 mm (palm), 0.19 mm (fingertip) | Yes |
| Physical Properties | |||
| Tensile Strength (Before Ageing) | 24 mpa | 27 mpa | Yes |
| Elongation at break % (Before Ageing) | 750% | 850% | Yes |
| Modulus at 500 % elongation (Before Ageing) | 5.5 mpa (max) | 3 mpa | Yes |
| Tensile Strength (After Ageing) | 18 mpa min | 20 mpa | Yes |
| Elongation at break % (After Ageing) | 560% min | 750% | Yes |
| Performance Requirements | |||
| Sterility | As per USP | As per IP (Indian Pharmacopeia) | Yes (Assumed equivalent in practice) |
| Freedom from Holes (AQL) | 1.5 | 1.5 (S4 inspection level) | Yes |
| Dimension (AQL) | 4 | 4 (S2 inspection level) | Yes |
| Physical Property (AQL) | 4 | 4 (S2 inspection level) | Yes |
| Other Properties | |||
| Powder Content | 150 mg/glove max (on Medium size) | 120 +/- 20 mg on size 8 (Implicitly meets for medium if met for size 8) | Yes |
| Protein Content | 200 ppm (max) (FDA Requirement) | 80 +/- 20 ppm | Yes |
| Moisture Content | No value fixed (FDA) | 0.8% max | N/A (Device provides stricter internal limit) |
| Biocompatibility | Biologically Compatible (FDA) | Biologically Compatible | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of gloves) used for each specific test. It indicates "BGPL Value" for measured parameters, suggesting the company conducted these tests. The provenance of the data is from Brightway Gloves Pvt. Ltd., located in Tamil Nadu, India. The tests appear to be a retrospective comparison against established standards (ASTM D3577 and FDA requirements) rather than a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The "ground truth" for this device is based on compliance with standardized measurements and performance specifications (ASTM D3577, USP, FDA requirements). These standards are developed by expert committees, but the submission does not detail the involvement of specific experts in establishing the ground truth for this particular test set.
4. Adjudication Method for the Test Set
This is not applicable as the compliance is based on objective, standardized measurements against published technical specifications rather than subjective expert assessment requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices where human interpretation of images or data is involved. Surgeon's gloves are a physical product, and their performance is evaluated through material science and physical property tests, not through human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is a physical product (surgeon's glove), not an algorithm or AI system. Its performance is inherent to the product itself, not mediated by an AI.
7. Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory requirements, specifically:
- ASTM D3577: Standard Specification for Rubber Surgical Gloves.
- USP (United States Pharmacopeia) / IP (Indian Pharmacopeia): For sterility testing.
- FDA Requirements: For protein content, moisture content (though no fixed value), and inherent biocompatibility.
These are specifications for physical and chemical properties, not clinical outcomes or expert consensus on a diagnostic interpretation.
8. Sample Size for the Training Set
This is not applicable. As a physical medical device (surgeon's gloves) being assessed for compliance with established performance standards, there is no "training set" in the context of machine learning or AI models. The gloves are manufactured and then tested to ensure they meet specifications.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8. There is no concept of a "training set" or "ground truth for a training set" for this type of device submission.
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(83 days)
EXAMINATION GLOVES POWDER FREE IS A POWDER FREE LATEX DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND ob eximali contrail contrainer time between batten and EXAMINER.
Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578
The device is a Latex Examination Glove (Powder free) manufactured by Brightway Gloves Pvt. Ltd., intended for medical purposes to prevent contamination between patients and examiners. The acceptance criteria and performance data are detailed below, comparing the device's characteristics against ASTM D3578 requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Size | Acceptance Criteria (ASTM D3578 Requirement) | Reported Device Performance (Brightway Gloves Value) | Meets Criteria? |
|---|---|---|---|---|
| Length | EX-S | 220 mm minimum | 235-240 mm | Yes |
| S | 220 mm minimum | 235-240 mm | Yes | |
| M | 230 mm minimum | 235-240 mm | Yes | |
| L | 230 mm minimum | 235-240 mm | Yes | |
| Width | EX S | 70 +/- 6 mm | 70 mm | Yes |
| S | 80 +/- 6 mm | 82 mm | Yes | |
| M | 95 +/- 6 mm | 93 mm | Yes | |
| L | 111 +/- 6 mm | 107 mm | Yes | |
| Thickness | EX S | 0.08 mm minimum | 0.10 mm | Yes |
| S | 0.08 mm minimum | 0.10 mm | Yes | |
| M | 0.08 mm minimum | 0.10 mm | Yes | |
| L | 0.08 mm minimum | 0.10 mm | Yes | |
| Physical Properties (Before Ageing) | ||||
| Tensile Strength | 14 mpa min | 20 - 22 mpa | Yes | |
| Elongation at break % | 700% min | 750 - 800% (or 750-850% in performance data) | Yes | |
| Physical Properties (After Ageing) | ||||
| Tensile Strength | 14 mpa min | 18 - 20 mpa | Yes | |
| Elongation at break % | 500% min | 700 - 800% | Yes | |
| Performance Requirement | ||||
| Freedom from Holes | Holes | AQL 4 | AQL 1.5 | Yes (lower AQL is better) |
| Dimension | Width, Length, Thickness | AQL 4 | AQL 4 | Yes |
| Physical Property | Tensile Strength, Elongation at Break | AQL 4 | AQL 4 | Yes |
| Powder Content | Not explicitly stated in ASTM D3578, but implied by "powder free" | 1 +/- 1 mg per glove | N/A (meets "powder free" claim) | |
| Protein Content | Not explicitly stated in ASTM D3578 | 80 +/- 20 ppm | N/A | |
| Moisture Content | Not explicitly stated in ASTM D3578 | 0.8% max | N/A | |
| Biocompatibility | Not explicitly stated in ASTM D3578 | Biologically Compatible | N/A (meets general expectation) |
2. Sample size used for the test set and the data provenance
The document states that the performance test data is for "Latex Examination Glove powder free manufactured by M/S Brightway Gloves Pvt.Ltd." However, the sample size used for these tests is not explicitly stated in the provided document. The data provenance is
retrospective by the manufacturer, Brightway Gloves Pvt. Ltd., located in Tamil Nadu, India.
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 the physical and performance properties of the gloves is established by the ASTM D3578 standard specifications. No human expert "ground truthing" is mentioned or implied for these types of measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a measurement of physical and performance characteristics against a standard, not a subjective assessment requiring adjudication among experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a Latex Examination Glove, not an AI or diagnostic medical device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a Latex Examination Glove, not an AI or algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is based on the ASTM D3578 standard specifications for Latex Examination Gloves. These are established industry standards for the physical and performance characteristics of such gloves.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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(83 days)
EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE MADE OF NATURAL LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER AND IS POWDERED WITH A DONNING POWDER ABSORBABLE USP CORN STARCH.
Class I Patient Examination Gloves (powdered) 80L that meets all 'the requirements of ASTM D3578.
Here's the breakdown of the acceptance criteria and study information for the Latex Examination Gloves (Powdered) from Brightway Gloves Pvt. Ltd., as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | SIZE | Acceptance Criteria (ASTM D3578) | Reported Performance (BGPL Value) | Meets Criteria? |
|---|---|---|---|---|
| Length | EX-S | 220 mm minimum | 235-240 mm | Yes |
| S | 220 mm minimum | 235-240 mm | Yes | |
| M | 230 mm minimum | 235-240 mm | Yes | |
| L | 230 mm minimum | 235-240 mm | Yes | |
| Width | EX S | 70 +/- 6 mm | 70 mm | Yes |
| S | 80 +/- 6 mm | 82 mm | Yes | |
| M | 95 +/- 6 mm | 93 mm | Yes | |
| L | 111 +/- 6 mm | 107 mm | Yes | |
| Thickness | EX S | 0.08 mm minimum | 0.10 mm | Yes |
| S | 0.08 mm minimum | 0.10 mm | Yes | |
| M | 0.08 mm minimum | 0.10 mm | Yes | |
| L | 0.08 mm minimum | 0.10 mm | Yes | |
| Tensile Strength (Before Ageing) | N/A | 14 mpa min | 20 - 22 mpa | Yes |
| Elongation at break % (Before Ageing) | N/A | 700% min | 800 - 850% | Yes |
| Tensile Strength (After Ageing) | N/A | 14 mpa min | 18 – 20 mpa | Yes |
| Elongation at break % (After Ageing) | N/A | 500% min | 750-800% | Yes |
| Freedom from Holes (AQL) | N/A | 4 | 1.5 (Reported as 'followed by BGPL', lower AQL is better) | Yes |
| Dimension (AQL) | N/A | 4 | 4 | Yes |
| Physical Property (AQL) | N/A | 4 | 4 | Yes |
| Powder Content | N/A | Not explicitly stated in table, but noted in "Conclusion" | 120 +/- 20 mg per glove | Yes (implied by conclusion) |
| Protein Content | N/A | Not explicitly stated in table, but noted in "Conclusion" | 80 +/- 20 ppm | Yes (implied by conclusion) |
| Moisture Content | N/A | Not explicitly stated in table, but noted in "Conclusion" | 0.8% max | Yes (implied by conclusion) |
| Biocompatibility | N/A | Not explicitly stated in table, but noted in "Conclusion" | Biologically Compatible | Yes (implied by conclusion) |
| Pin hole Requirement | N/A | FDA Pin hole Requirement | Not explicitly quantified, but stated "Meet FDA Pin hole Requirement" | Yes |
Note: For characteristics like Powder Content, Protein Content, Moisture Content, and Biocompatibility, no specific ASTM D3578 numerical requirement was explicitly listed in the tables provided for direct comparison. However, the "Conclusion of Performance Test Data" explicitly states that the gloves "Meet or exceed the ASTM D3578" and "Meet FDA Pin hole Requirement" and "Meet labelling claim," implying that the stated performance values for these attributes align with the relevant standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set for each parameter. It lists the measured values for various glove sizes and properties. The data provenance is from India (manufacturer is M/s. BRIGHTWAY GLOVES PVT.LTD. in Tamil Nadu, India). The study appears to be retrospective in the sense that it presents the results of tests already conducted (e.g., "The performance test data... given below").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a medical device (patient examination gloves) that is evaluated against established technical standards (ASTM D3578) and regulatory requirements (FDA pinhole requirement). The ground truth is objective measurement data against these standards, not expert interpretation of subjective information.
4. Adjudication Method for the Test Set
N/A. As mentioned above, the determination is based on objective measurements against predefined standards, not subjective assessments requiring adjudication among experts.
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 is a physical medical device (gloves), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for this device is based on established industry standards and regulatory requirements, specifically:
- ASTM D3578 (Standard Specification for Rubber Examination Gloves)
- FDA Pinhole Requirement
These provide objective benchmarks for physical, chemical, and performance properties.
8. The sample size for the training set
N/A. This is a physical medical device. The concept of a "training set" is relevant for AI algorithms, not for the manufacturing and testing of examination gloves. The product undergoes quality control and testing against specifications, not machine learning model training.
9. How the ground truth for the training set was established
N/A. As above, the concept of a "training set" and its ground truth establishment is not applicable to this type of device.
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