(73 days)
Fowder Free Latex Examination Glove is a device intended for medical use , worn by the Examiner on his hands / fingers to prevent contamination between Patient and Examiner.
Class 1- Patient Examination Gloves(Powder Free) ROL YY that meets all the requrements ASTM D 3578-95.
The provided text outlines the acceptance criteria and performance data for "Powder Free Latex Examination Gloves" manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED. The study presented is a technical performance study demonstrating equivalence to a predicate device and adherence to ASTM and FDA standards for medical examination gloves.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3578 / FDA Requirement) | Reported Device Performance (SARI Value) |
|---|---|---|
| Dimensions | ||
| Length (Ex-S to Ex-L) | 220 mm min (Ex-S, S); 230 mm min (M, L, Ex-L) | 240-245mm (Ex-S, S, M); 245-250mm (L, Ex-L) |
| Width (Ex-S to Ex-L) | 70 +/- 6 mm; 80 +/- 6 mm; 95 +/- 6 mm; 111 +/- 6 mm; 114 +/- 6 mm | 71mm (Ex-S); 82mm (S); 95mm (M); 106mm (L); 110mm (Ex-L) |
| Thickness (Ex-S to Ex-L) | 0.08 mm minimum | 0.11mm (Ex-S); 0.12mm (S, M); 0.10mm (L); 0.11mm (Ex-L) |
| Physical Properties (Before Ageing) | ||
| Tensile Strength | 14 mpa min. | 21-24 mpa |
| Elongation at Break % | 700% min. | 800-850% |
| Physical Properties (After Ageing) | ||
| Tensile Strength | 14 mpa min. | 19-22 mpa |
| Elongation at Break % | 500% min. | 700-800% |
| Performance Requirements (AQL) | ||
| Freedom from Holes | 4 (ASTM D3578) | 1.5 (SARI) |
| Dimensions | 4 (ASTM D3578) | 4 (SARI) |
| Physical Property | 4 (ASTM D3578) | 4 (SARI) |
| Other Properties | ||
| Powder Content | 2 mg/glove max (ASTM Requirement) | 1 +/- 1 mg per glove (also listed as 80 +/- 20, likely a typo or mislabeling in the document with the 1 +/- 1 mg per glove being the most direct statement of performance against 2mg/glove max) |
| Protein Content | Value not fixed (FDA Requirement) | 80 +/- 20 ppm |
| Moisture Content | Value not fixed (FDA Requirement) | 0.4% maximum |
| Biocompatibility | Biologically Compatible (FDA Requirement) | Biologically Compatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the performance tests. However, it indicates adherence to Acceptance Quality Limits (AQL) standards for inspection (S4 for holes, S2 for dimensions and physical properties), which implies a statistically determined sample size would have been used according to industrial quality control practices.
The data provenance is retrospective, as it's presented as part of a 510(k) submission, showcasing the device's characteristics against established standards. The data originates from India (SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED, Tamil Nadu, India).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts) is not applicable to this study. The "ground truth" for medical examination gloves is established by predefined international standards and regulations (e.g., ASTM D3578, FDA requirements) rather than expert consensus on individual cases. The testing involves objective measurements against these established criteria.
4. Adjudication Method for the Test Set
This is not applicable. As mentioned above, the "truth" is based on objective measurements against established standards, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, where AI assistance might improve reader performance. This document concerns the physical and chemical properties of a medical glove, which does not involve human interpretation in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in spirit, a standalone performance evaluation was done. The device (the glove) is evaluated on its own merits against specified criteria without human intervention affecting its inherent performance. The measurements taken for length, width, thickness, tensile strength, elongation, powder content, etc., are all objective assessments of the device itself.
7. The Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory requirements, specifically:
- ASTM D3578-95: Standard Specification for Latex Examination Gloves.
- FDA Requirements: For general examination gloves, including pinhole requirements and biocompatibility.
8. The Sample Size for the Training Set
This concept is not applicable to the presented documentation. This is not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of traditional AI/ML. The manufacturing process of the gloves would involve quality control and process monitoring, but this doesn't constitute a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" in the AI/ML context, this question is not applicable. The "ground truth" for the manufacturing process would be the target specifications defined by ASTM D3578 and FDA regulations, guided by manufacturing best practices and quality control.
§ 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.