(56 days)
Powder free Latex Examination Gloves with Bubblegum Aroma is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.
Powder free Latex Examination Gloves with Bubblegum Aroma
The provided text describes the 510(k) summary for "Powder free Latex Examination Gloves with Bubblegum Aroma." This document is a premarket notification for a medical device, which means it aims to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based diagnostic or assistive device. Instead, it details the characteristics and performance of the examination gloves themselves, comparing them to established industry standards like ASTM D 3578-01ae2.
Therefore, many of the requested categories for AI/algorithm performance studies are not applicable to this document. I will answer based on the information provided for the physical device (gloves).
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance (Powder-Free Latex Examination Gloves with Bubblegum Aroma) |
|---|---|---|
| Dimensions | (Implied by standard) | |
| Length (min.) | Not explicitly stated | Small: 220 mm, Medium: 230 mm, Large: 230 mm, X-Large: 230 mm |
| Palm Width | Not explicitly stated | Small: 80±10 mm, Medium: 95±10 mm, Large: 110±10 mm, X-Large: 120±10 mm |
| Thickness Cuff (min) | Not explicitly stated | 0.08 mm (across all sizes) |
| Thickness Palm (min) | Not explicitly stated | 0.08 mm (across all sizes) |
| Thickness Finger Tip (min) | Not explicitly stated | 0.08 mm (across all sizes) |
| Physical Properties | ASTM D 3578-01ae2 | |
| Tensile Strength (Before ageing) | 18 MPa (min) | : 18 MPa (min) (implicitly meets or exceeds) |
| Ultimate Elongation (Before ageing) | 650% (min) | : 650% (min) (implicitly meets or exceeds) |
| Tensile Strength (After ageing at 70°C 168 hrs.) | 14 MPa (min) | 14 MPa (min) (implicitly meets or exceeds) |
| Ultimate Elongation (After ageing at 70°C 168 hrs.) | 500% (min) | 500% (min) (implicitly meets or exceeds) |
| Pin Hole Requirements | FDA pin hole requirement | Meets FDA pin hole requirement |
| Protein Content | 50 mcg/gm or less per glove | 50 mcg/gm or less protein per glove |
| Labeling Claims | Not explicitly stated | Meets labeling claim |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For physical products like gloves, testing is typically done on batches during manufacturing and as part of compliance to standards, but the specific sample sizes for these tests are not detailed here. The manufacturing company is located in Indonesia.
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)
This is not applicable as the document describes physical product testing against engineering standards rather than diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes physical product testing against engineering standards rather than diagnostic interpretation.
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 is not applicable as the document describes physical product testing, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the document describes physical product testing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is the compliance with established industry standards and regulatory requirements, specifically:
- ASTM D 3578-01ae2 Standard for Latex Examination Gloves.
- FDA pin hole requirement.
- Protein content limits (50 mcg/gm or less).
- Labeling claims.
8. The sample size for the training set
This is not applicable as the document describes physical product testing, not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable as the document describes physical product testing, not a machine learning model. The "ground truth" for the device's performance is established by adhering to the standards mentioned in point 7.
§ 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.