(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.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.