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510(k) Data Aggregation
(51 days)
Powder free Synthetic Nitrile Neoprene Examination Gloves is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Powder free Synthetic Nitrile Neoprene Examination Gloves
The provided text describes the acceptance criteria and performance data for "Powder free Synthetic Nitrile Neoprene Examination Gloves." It details the technological characteristics and performance benchmarks the gloves are designed to meet.
Here's an analysis of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions (minimum) | ||
| Length mm | 240 (all sizes: Small, Medium, Large, X-Large) | Same as acceptance criteria |
| Palm Width mm (Small) | $80 \pm 10$ | Same as acceptance criteria |
| Palm Width mm (Medium) | $95 \pm 10$ | Same as acceptance criteria |
| Palm Width mm (Large) | $111 \pm 10$ | Same as acceptance criteria |
| Palm Width mm (X-Large) | $\ge 110$ | Same as acceptance criteria |
| Thickness mm (min.) | ||
| - Cuff | 0.10 (all sizes) | Same as acceptance criteria |
| - Palm | 0.10 (all sizes) | Same as acceptance criteria |
| - Finger Tip | 0.10 (all sizes) | Same as acceptance criteria |
| Physical Properties | ||
| Tensile Strength | ||
| - Before aging | : 21 Mpa (min) | Same as acceptance criteria |
| - After aging | : 14 Mpa (min) (at 70°C 168 hrs.) | Same as acceptance criteria |
| Ultimate Elongation | ||
| - Before aging | : 700 % (min.) | Same as acceptance criteria |
| - After aging | : 500 % (min.) (at 70°C 168 hrs.) | Same as acceptance criteria |
| Other Standards | ASTM D 6319-00 compliance, FDA pinhole requirement | Meets or exceeds ASTM D 6319-00, Meets FDA pinhole requirement, Meets labeling claim |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for testing each specific criterion (e.g., how many gloves were tested for dimensions, tensile strength, or pinholes).
The data provenance is from PT. Shamrock Manufacturing Corporation in North Sumatra - Indonesia. The data presented is part of a 510(K) submission, which typically involves demonstrating that the device meets established standards through testing, implying prospective testing for the submitted device, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. For physical and dimensional tests of examination gloves, ground truth is typically established by laboratory measurements calibrated to international standards, not by expert consensus in the conventional sense.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For the types of tests described (dimensional, physical properties, pinhole), adjudication is typically based on objective measurement against predefined numerical standards (e.g., ASTM D 6319-00 compliance, FDA pinhole requirement), rather than an expert consensus or arbitration process.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable and was not done. The device is an examination glove, which is a physical product, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance data of the examination gloves is based on:
- Established Industry Standards: Primarily ASTM D 6319-00, which defines the requirements for synthetic nitrile/neoprene examination gloves.
- Regulatory Requirements: Specifically, the FDA pinhole requirement for examination gloves.
- Direct Physical Measurements: For dimensions, tensile strength, and ultimate elongation.
These are objective, measurable criteria, not subjective expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product, not a machine learning model, so there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
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(42 days)
Powderfree Nitrile Neoprene Examination Glove is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Powder free Nitrile Neoprene Examination Gloves is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
The Shamrock Manufacturing Corporation's Powder Free Nitrile Neoprene Examination Gloves have acceptance criteria based on established ASTM and FDA standards for medical gloves. The study proving the device meets these criteria is the certification that the gloves meet or exceed ASTM D6319-00a Standard and FDA pinhole requirements.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (ASTM D6319-00a & FDA) | Reported Device Performance (Shamrock Manufacturing Corp.) |
|---|---|---|
| Dimensions | ||
| Length mm (min.) - Small | (Implied by standard) | 220 |
| Length mm (min.) - Medium | (Implied by standard) | 230 |
| Length mm (min.) - Large | (Implied by standard) | 230 |
| Length mm (min.) - X-Large | (Implied by standard) | 230 |
| Palm Width mm - Small | (Implied by standard) | $80 \pm 10$ |
| Palm Width mm - Medium | (Implied by standard) | $95 \pm 10$ |
| Palm Width mm - Large | (Implied by standard) | $111 \pm 10$ |
| Palm Width mm - X-Large | (Implied by standard) | $120 \pm 10$ |
| Cuff Thickness mm (min) | (Implied by standard) | 0.05 |
| Palm Thickness mm (min) | (Implied by standard) | 0.05 |
| Finger Tip Thickness mm (min) | (Implied by standard) | 0.05 |
| Physical Properties | ||
| Tensile Strength (Before Ageing) | 14 MPa (min) (ASTM D6319-00a) | 14 MPa (min) |
| Ultimate Elongation (Before Ageing) | 500 % (min) (ASTM D6319-00a) | 500 % (min) |
| Tensile Strength (After Ageing at 70°C 168 hrs.) | 14 MPa (min) (ASTM D6319-00a) | 14 MPa (min) |
| Ultimate Elongation (After Ageing at 70°C 168 hrs.) | 400 % (min) (ASTM D6319-00a) | 400 % (min) |
| Pinhole Requirement | Meets FDA pinhole requirement | Meets FDA pinhole requirement |
| Labeling Claim | Meets labeling claim | Meets labeling claim |
Note: The document explicitly states "Performance data is the same as mentioned immediately above," referring to the physical properties table. For dimensions, the listed values are presumably the required criteria from ASTM D6319-00a, which the device is stated to meet.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for testing the gloves. It only reports that the company certifies the gloves "meet or exceed ASTM D6319-00a Standard" and "Meets FDA pinhole requirement" and "Meets labeling claim."
The data provenance is from Indonesia, as Shamrock Manufacturing Company is located in J1. Raya Medan - Namorambe PS IV Kabupaten Deli Serdang - Indonesia. The document does not specify if the testing was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set. The ground truth is based on the ASTM D6319-00a standard and FDA pinhole requirements, which are established industry and regulatory standards.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Compliance is assessed against the pre-defined standards (ASTM D6319-00a and FDA pinhole requirements).
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 question is not applicable as the device is a physical product (medical gloves) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI-related comparative effectiveness was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical product (medical gloves) and not an algorithm.
7. The Type of Ground Truth Used
The type of ground truth used is pre-established industry standards and regulatory requirements:
- ASTM D6319-00a Standard: This specifies physical requirements (such as dimensions, tensile strength, and elongation) for nitrile examination gloves.
- FDA Pinhole Requirement: This is a regulatory standard for the barrier integrity of examination gloves.
- Labeling Claim: This refers to ensuring the physical product matches its described characteristics and intended use.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical medical device, not a machine learning model.
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