(85 days)
A latex 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
A sterile latex powderfree 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.
Latex Powder free Sterile Examination Gloves
The provided text describes the acceptance criteria and a study for "Latex Powder free Sterile Examination Gloves."
Here's the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Performance Requirement) | Reported Device Performance |
|---|---|---|
| Sterility | Fails sterility (Related Defects) | Meets the sterility assurance level. |
| Freedom from holes | Holes (Related Defects) | Meets FDA pinhole requirement. |
| Dimensions & Thickness | Width, Length (Related Defects) | Meets ASTM D 3578-01 Standard. (Implied) |
| Physical Properties (after ageing) | Before and After (Related Defects) | Meets ASTM D 3578-01 Standard. (Implied) |
| Tensile Strength: 14 Mpa (before & after ageing) | ||
| Ultimate Elongation: 650% (min, before ageing), 600% (min, after ageing) | ||
| Powder Free Residue | Exceeds Maximum Limit | Meets labeling claim. (Implied, if labeling claims "powder free") |
| Exceeds Recommended Maximum Limit (Powder Amount, separate) | ||
| Protein Content | Exceeds Recommended Maximum Limit | Not explicitly stated, but implied to meet claims. |
| Powder Amount | Exceeds Recommended Maximum Limit | Meets labeling claim. (Implied) |
Note: The document states "Performance data is the same as mentioned immediately above," referring to the table of "Technological characteristic of the gloves" and "Performance requirement." The "Non-clinical data" section then certifies that these requirements are met.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each test set. However, it does provide Inspection Levels and AQL values for some characteristics, which would imply specific sample sizes based on sampling plans. For instance:
- Freedom from holes: Inspection Level 1, AQL 2.5
- Dimensions & Thickness: Inspection Level S-2, AQL 4
- Physical Properties (after ageing): Inspection Level S-2, AQL 4
- Powder Free Residue: N=5
- Protein Content: N=3
- Powder Amount: N=2
The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer PT. Maja Agung Latexindo in North Sumatra, Indonesia. The study appears to be retrospective as it presents data for a device seeking 510(k) clearance based on established 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 acceptance criteria are based on ASTM standards (ASTM D 3578-01), FDA pinhole requirements, and generally accepted sterility assurance levels. The compliance is certified by the manufacturer. There is no mention of external experts establishing ground truth for individual test cases.
4. Adjudication Method for the Test Set
This information is not provided. The compliance is self-certified by the manufacturer against established 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
This is not applicable. The device is a physical product (latex gloves), not an AI diagnostic tool. No MRMC study or AI assistance is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical product (latex gloves), not an AI diagnostic tool.
7. The Type of Ground Truth Used
The ground truth is based on established industry standards and regulatory requirements, specifically:
- ASTM D 3578-01 Standard (for dimensions, physical properties)
- FDA pinhole requirement
- Sterility assurance level
- Labeling claims (for powder free, powder amount)
These standards define the objective measures for performance.
8. The Sample Size for the Training Set
This is not applicable as the document describes the testing of a physical product, not the development of a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned for this product.
§ 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.