(45 days)
Nitrile Examination Glove is a disposable device made of Nitrile Latex intended for medi purpose, that is worn on the examiners hand or linger to prevent contamination between patie and Examiner.
Class I Patient Examination (Floves ( Nitrile) 801 7.A that meets all 'the requirements of ASTM D3578- 95.
Here's a breakdown of the acceptance criteria and study information for the Nitrile Examination Glove, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D3578 Requirement) | Reported Device Performance (Anusham Latex/SARI Value) |
|---|---|---|
| Length | ||
| EX-S | 220 mm minimum | 235-240 mm |
| S | 220 mm minimum | 235-240 mm |
| M | 230 mm minimum | 235-240 mm |
| L | 230 mm minimum | 235-240 mm |
| Width | ||
| EX S | 70 +/- 6 mm | 70MM |
| S | 80 +/- 6 mm | 82 mm |
| M | 95 +/- 6 mm | 93 mm |
| L | 111 +/- 6 mm | 107 mm |
| Thickness | ||
| EX S | 0.08 mm minimum | 0.10mm |
| S | 0.08 mm minimum | 0.10mm |
| M | 0.08 mm minimum | 0.10mm |
| L | 0.08 mm minimum | 0.10mm |
| Physical Properties (Before Ageing) | ||
| Tensile Strength | 14 mpa min | 18 - 20 mpa |
| Elongation at break % | 700% min | 750 - 800% |
| Physical Properties (After Ageing) | ||
| Tensile Strength | 14 mpa min | 16 - 18 mpa |
| Elongation at break % | 500% min | 650 - 700% |
| Performance Requirement: Freedom from Holes | AQL 4 (Level S4) | AQL 1.5 (Level S4) |
| Performance Requirement: Dimension | AQL 4 (Level S2) | AQL 4 (Level S2) |
| Performance Requirement: Physical Property | AQL 4 (Level S2) | AQL 4 (Level S2) |
| Powder Content | Not explicitly stated (implied by "AQL followed by SARI") | 120 +/- 20 mg per glove |
| Protein Content | Not explicitly stated (implied by "AQL followed by SARI") | 30 +/- 10 ppm |
| Moisture Content | Not explicitly stated (implied by "AQL followed by SARI") | 0.8% max |
| Biocompatibility | Not explicitly stated (implied by "AQL followed by SARI") | Biologically Compatible |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the exact sample size used for the performance testing. It refers to "Measured Parameters of Examination gloves (Nitrile) manufactured by Anusham Latex" and "Performance test data of the Nitrile examination glove manufactured by Sri. Anusham Rubber Industries Pvt Ltd".
- Data Provenance: The data is reported by M/s. SRLANUSHAM RUBBER INDUSTRIES PVT.LTD, located in TAMILNADU, INDIA. The data appears to be retrospective as it is presented as completed performance tests.
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 performance data is based on physical and chemical testing against ASTM standards, not expert human assessment.
4. Adjudication method for the test set:
This is not applicable as the evaluations are based on objective physical/chemical measurements against predefined standards (ASTM D3578) rather than subjective expert interpretation requiring adjudication.
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 information is not applicable. This document describes the performance characteristics of a physical medical device (examination gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. This document describes the performance of a physical product.
7. The type of ground truth used:
The ground truth used for evaluating the device's performance is established industry standards and regulatory requirements, specifically:
- ASTM D3578-95: "Standard Specification for Rubber Examination Gloves." This standard defines the physical property requirements for examination gloves.
- FDA Pin Hole Requirement: A regulatory standard for barrier integrity.
- Labelling claim: The device's performance against its own stated specifications.
8. The sample size for the training set:
This information is not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
§ 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.