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510(k) Data Aggregation
(64 days)
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(52 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between and patient examiners that require a sterile procedure.
A latex examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiners that require a sterile procedure.
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This document is a 510(k) Summary for Latex Examination Gloves, Pre-powdered. It outlines the device's technical characteristics and performance data to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the provided information, structured to address your request about acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM D 3578-95, a standard for Latex Examination Gloves. The reported device performance indicates compliance with these standards.
| Characteristic | Acceptance Criteria (ASTM D 3578-95) | Reported Device Performance |
|---|---|---|
| Dimensions | ||
| Length (XS, S, M, L, XL) | ≥ 240 mm | 240 mm for all sizes (XS, S, M, L, XL) |
| Width (XS) | 111 mm | > 111 mm |
| Thickness (Cuff) | ≥ 0.10 mm | 0.10 mm (min) |
| Thickness (Palm) | ≥ 0.10 mm | 0.10 mm (min) |
| Thickness (Finger Tip) | ≥ 0.10 mm | 0.10 mm (min) |
| Physical Properties (Before Ageing) | ||
| Tensile Strength | 21 Mpa (min) | 21 Mpa (min) |
| Ultimate Elongation | 700 % (min) | 700 % (min) |
| Physical Properties (After Ageing at 100°C 22 hrs) | ||
| Tensile Strength | 16 Mpa (min) | 16 Mpa (min) |
| Ultimate Elongation | 600 % (min) | 600 % (min) |
| Performance Requirements (AQLs) | ||
| Visible Defects (Stains, Lumps, Holes etc.) | AQL 2.5 (Inspection Level S-4) | Meets AQL 2.5 |
| Watertight (Holes) | AQL 1.5 (Inspection Level S-4) | Meets AQL 1.5 (Meets FDA pinhole requirement) |
| Dimensions (Width, Length & Thickness) | AQL 4 (Inspection Level S-2) | Meets AQL 4 |
| Physical Properties (Before and after ageing) | AQL 4 (Inspection Level S-2) | Meets AQL 4 |
| Sterility (Fails sterility) | Not Acceptable | Meets the sterility assurance level |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample sizes for each test (e.g., number of gloves tested for dimensions, watertightness, etc.). However, it refers to "Inspection Level S-4" and "S-2" for various performance requirements, which are standard sampling plans defined in relevant quality control regulations (likely ISO 2859 or military standards for sampling by attributes). These levels imply specific sample sizes will be drawn based on the batch size, but the exact number isn't provided here.
Data Provenance: The manufacturing company is PT. Maja Agung Latexindo, located in Sumatera Utara, Indonesia. The tests were performed to meet the ASTM D 3578-95 standard, an international standard. The data itself is likely generated internally by the manufacturer during quality control processes. It is retrospective data, as it describes the performance of already manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of medical device (latex examination gloves) does not typically involve human experts to establish "ground truth" for performance tests in the same way an AI diagnostic algorithm might. The "ground truth" for these tests is defined by objective, measurable parameters (e.g., physical dimensions, tensile strength, absence of holes) as specified in the ASTM D 3578-95 standard. The tests are conducted using standardized methods and equipment. Therefore, there's no mention of experts establishing ground truth in terms of clinical interpretation.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" for these tests is objective and quantitative, defined by the ASTM standard. There would be no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for comparing the diagnostic performance of human readers, often with and without AI assistance, especially in image interpretation. This document pertains to the physical and mechanical properties of medical gloves, not a diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "device" in this context is the physical latex glove. Its performance is evaluated directly through various laboratory tests (dimensional measurements, tensile strength tests, water leak tests, sterility tests) without human intervention in the interpretive phase (except for performing the tests and recording results). There is no "algorithm" involved in the performance testing of these gloves as there would be for an AI-powered device.
7. The Type of Ground Truth Used
The ground truth used is based on objective, quantitative measurements and adherence to established performance standards (ASTM D 3578-95). For example:
- Dimensions: Measured values compared against specified ranges.
- Physical Properties: Measured tensile strength and elongation compared against minimum requirements.
- Watertightness: Absence of holes determined by a water leak test, conforming to FDA pinhole requirements.
- Sterility: Absence of microbial growth, conforming to sterility assurance levels.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product (latex gloves), not an artificial intelligence model or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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(81 days)
A surgeon's glove is a disposable device intended for medical purpose that is worn on surgeon's hands during surgical operations to prevent contamination between patient surgeon's
Latex Surgeon's Gloves Pre-Powdered Sterile
The provided document is a 510(k) summary for "Latex Surgeon's Gloves Pre-Powdered Sterile" from PT. MAJA AGUNG LATEXINDO. It details the device's characteristics, performance criteria, and a statement that the performance data meets these criteria.
Here's an analysis to extract the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Before ageing) | Acceptance Criteria (After ageing at 70°C 168 hrs) | Reported Device Performance (Implied) |
|---|---|---|---|
| Dimensions: | Meets ASTM D 3577 Standard | ||
| Length mm (min.) Sizes | 265 | N/A | Reported as meeting criteria |
| Palm Width mm (for sizes) | $83 \pm 6$ to $108 \pm 6$ | N/A | Reported as meeting criteria |
| Thickness 1. Cuff mm (min) | 0.10 | N/A | Reported as meeting criteria |
| Thickness 2. Palm mm(min) | 0.10 | N/A | Reported as meeting criteria |
| Thickness 3. Finger Tip mm | 0.10 | N/A | Reported as meeting criteria |
| Physical Properties: | Meets ASTM D 3577 Standard | ||
| Tensile Strength | 24 Mpa (min) | 18 Mpa (min) | Reported as meeting criteria |
| Ultimate Elongation | 750 % (min.) | 560 % (min.) | Reported as meeting criteria |
| Stress at 500 % Elongation | 5.5 (max) | N/A | Reported as meeting criteria |
| Performance Requirements: | |||
| Watertight (Holes) | AQL 1.5 | N/A | Meets FDA pin hole requirement |
| Dimensions | AQL 4.0 | N/A | Reported as meeting criteria |
| Physical Properties | AQL 4.0 | N/A | Reported as meeting criteria |
| Sterility | Not Acceptable for Fails Sterility | N/A | Meets the sterility assurance level |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the sample size used for the test set. It refers to "Inspection Level S-4" and "S-2" and "AQL" values for performance characteristics, which imply sampling plans were used according to standards like ASTM or ISO, but the exact number of units tested is not provided.
- Data Provenance: The data appears to be from the manufacturer, PT. MAJA AGUNG LATEXINDO, based in Indonesia. The nature of the data (retrospective or prospective) is not specified, but it represents testing conducted to demonstrate compliance with standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The established ground truth for performance characteristics is based on objective measurements and adherence to ASTM D 3577 and FDA requirements, rather than expert consensus on subjective findings.
4. Adjudication method for the test set
This information is not provided in the document. Given the objective nature of the tests (dimensions, tensile strength, elongation, watertightness, sterility), an adjudication method in the context of expert review would likely not be applicable. The results would be a direct measurement against the specified criteria.
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
- No MRMC study was done. This device is a physical product (latex surgeon's gloves), not an AI-assisted diagnostic or therapeutic tool. Therefore, a study comparing human reader performance with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As the device is a physical product, there is no algorithm or AI component to perform in a standalone manner.
7. The type of ground truth used
The ground truth used for this device is based on objective measurement against established industry standards and regulatory requirements.
- ASTM D 3577 Standard: For dimensions and physical properties.
- FDA pin hole requirement: For watertightness.
- Sterility Assurance Level: For sterility.
These are well-defined, quantitative standards.
8. The sample size for the training set
- Not applicable. This device is a physical product; there is no machine learning model or algorithm that requires a "training set" in the conventional sense. The product design and manufacturing processes are likely informed by industry experience and engineering principles rather than a data-driven training set.
9. How the ground truth for the training set was established
- Not applicable. As explained above, there is no training set for this type of device. The "ground truth" for ensuring the quality of the manufacturing process would be established through quality control procedures, adherence to Good Manufacturing Practices (GMP), and material specifications, all designed to meet the performance standards.
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(128 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners.
Latex Examination Gloves Powder Free with Protein Claim
The provided text describes information related to a 510(k) submission for "Latex Examination Gloves Powder Free with Protein Claim" by PT. MAJA AGUNG LATEXINDO. While it details the device and its intended use, it does not explicitly contain a section titled "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format of a clinical study with detailed statistical results.
However, based on the provided text, the acceptance criteria for these gloves are primarily performance requirements and physical characteristics that are expected to meet certain standards, particularly ASTM D 3578-95 and FDA's pinhole requirement. The "study" proving these are met seems to be through non-clinical testing as specified in the document.
Here's an attempt to structure the available information into the requested format, inferring where explicit details are missing:
Acceptance Criteria and Device Performance Study (Inferred from 510(k) Submission)
The acceptance criteria for the Latex Examination Gloves Powder Free with Protein Claim are primarily based on established industry standards and regulatory requirements. The device's performance is demonstrated through non-clinical testing against these specified criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions (as per ASTM) | Length: min. 240 mm (all sizes) | Length: 240 mm (reported for S, M, L) |
| Palm Width Thickness: Small: 85±10 mm; Medium: 95±10 mm; Large: 111±10 mm | Palm Width Thickness: Small: 85±10 mm; Medium: 95±10 mm; Large: 111±10 mm | |
| Cuff Thickness: min. 0.10 mm | Cuff Thickness: 0.10 mm | |
| Palm Thickness: min. 0.10 mm | Palm Thickness: 0.10 mm | |
| Finger Tip Thickness: min. 0.10 mm | Finger Tip Thickness: 0.10 mm | |
| Physical Properties (as per ASTM) | Tensile Strength (Before Ageing): 21 MPa | Tensile Strength (Before Ageing): 21 Mpa |
| Tensile Strength (After Ageing at 70°C 168 hrs): 16 MPa | Tensile Strength (After Ageing at 70°C 168 hrs): 16 Mpa | |
| Ultimate Elongation (Before Ageing): min. 700 % | Ultimate Elongation (Before Ageing): 700 % (min.) | |
| Ultimate Elongation (After Ageing at 70°C 168 hrs): min. 600 % | Ultimate Elongation (After Ageing at 70°C 168 hrs): 600 % (min.) | |
| Performance Requirements | Watertight: Related Defects: Holes; Inspection Level: S-4; AQL: 2.5 | Meets FDA pin hole requirement |
| Dimensions: Related Defects: Width, Length & Thickness; Inspection Level: S-2; AQL: 4 | Meets specified dimensions | |
| Physical Properties: Related Defects: Before and after ageing; Inspection Level: S-2; AQL: 4 | Meets specified physical properties | |
| Chemical/Biological | Weight of residual powder (medium size gloves): 0.50 ± 0.20 mg | 0.50 ± 0.20 mg |
| Total water extractable protein: 50 microgram/gram (maximum) | 50 microgram/gram (maximum) | |
| Bio-Compatibility: | (Attached as Annexure XII) | |
| Standards Compliance | Meet ASTM D 3578-95 AQL requirements | Test Results as per ASTM D 3578-95 (Attached as Annexure V) |
| Meet FDA pin hole requirement | Meets FDA pin hole requirement | |
| Meets labeling claim | Meets labeling claim |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for the testing of each criterion. However, it references ASTM D 3578-95 and inspection levels (S-4, S-2) with AQL values (2.5, 4) for performance requirements. These standards typically define the sampling plans and sample sizes for quality control and lot acceptance.
- Provenance: Non-clinical test data generated, likely by the manufacturer (PT. MAJA AGUNG LATEXINDO), in Indonesia. The data is retrospective in the context of this 510(k) submission, as it was generated prior to submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable in this context. The "ground truth" for the performance of the gloves is established by objective, standardized tests as per ASTM specifications and FDA requirements, not by expert consensus on subjective observations. The testing would have been conducted by trained laboratory personnel.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of interpretations (e.g., medical image reading). The results are 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 device is a medical glove, not an AI-assisted diagnostic or decision-support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The device itself is the glove, and its performance is assessed directly through physical and chemical testing.
7. The type of ground truth used
The "ground truth" is defined by objective, quantitative measurements and adherence to established industry standards (e.g., ASTM D 3578-95) and regulatory requirements (e.g., FDA pinhole requirement, protein content limits). This includes:
- Physical measurements (dimensions, tensile strength, elongation)
- Chemical analysis (residual powder, extractable protein)
- Integrity testing (watertightness/pinhole testing)
- Biological testing (biocompatibility, referenced as Annexure XII)
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 training set in the AI sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "ground truth" for the device's performance is established by the accepted international and national standards it claims to meet.
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