(50 days)
Examination glove (Nitrile) is a disposable device made of Nitrile Latex intended for medical purpose that is worn on the examiners hand or finger to prevent contamination between patient and examiner.
Class I Patient Examination Gloves ( Nitrile) 80LZA that meets all 'the requirements of ASTM D3578- 95.
This document describes the performance and acceptance criteria for Shiva Medicare Limited's Powdered Nitrile Examination Gloves.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria (ASTM D3578 Requirement) | Reported Device Performance (Shiva Medicare Ltd. Value) |
|---|---|---|
| Length (minimum) | ||
| EX-S | 220 mm min | 235-240 mm |
| S | 220 mm min | 235-240 mm |
| M | 230 mm min | 235-240 mm |
| L | 230 mm min | 235-240 mm |
| Width | ||
| EX S | 70 +/- 6 mm | 70 MM |
| S | 80 +/- 6 mm | 82 mm |
| M | 95 +/- 6 mm | 93 mm |
| L | 111 +/- 6mm | 107 mm |
| Thickness (minimum) | ||
| EX S | 0.08 mm min | 0.10mm |
| S | 0.08 mm min | 0.10mm |
| M | 0.08 mm min | 0.10mm |
| L | 0.08 mm min | 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 (AQL) | ||
| Freedom from Holes | 4 (ASTM D3578) | 1.5 (SML) |
| Dimension | 4 (ASTM D3578) | 4 (SML) |
| Physical Property | 4 (ASTM D3578) | 4 (SML) |
| Powder Content | Not explicitly stated in ASTM D3578 table | 120 +/- 20 mg / glove |
| Protein Content | Not explicitly stated in ASTM D3578 table | 30 +/- 10 ppm |
| Moisture Content | Not explicitly stated in ASTM D3578 table | 0.8% max |
| Biocompatibility | Biologically compatible | Biologically Compatible |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., length, width, tensile strength). It refers to the "performance test data" but doesn't detail the sampling plan.
The data provenance is:
- Country of Origin: India (Shiva Medicare Limited is located in Chennai, India).
- Retrospective or Prospective: Not explicitly stated, but the tests were conducted on gloves manufactured by Shiva Medicare Limited to demonstrate compliance with ASTM D3578-95, suggesting these were contemporary tests on their product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This is a technical performance study of a physical device (gloves), not a diagnostic device requiring expert interpretation of images or clinical data. The "ground truth" is defined by the objective measurement standards outlined in ASTM D3578-95.
4. Adjudication Method for the Test Set:
Not applicable, as this is a physical device performance study. The evaluation is based on direct measurement and adherence to the specified ASTM standard.
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:
Not applicable. This is not an AI-powered diagnostic device, but a medical glove.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI-powered device. The device itself (the glove) is what's being evaluated, and its performance is measured directly against technical specifications.
7. The Type of Ground Truth Used:
The ground truth used is objective measurement against established industrial standards, specifically ASTM D3578-95 for examination gloves. These standards define the acceptable ranges for physical properties like dimensions, tensile strength, elongation, and freedom from holes. For Powder, Protein, and Moisture content, specific SML values are provided with no direct ASTM D3578 comparative requirement stated in the table, implying these are internal specifications or generally accepted values. Biocompatibility is stated as "Biologically Compatible" without further detail on the specific tests or standards used, though it implies compliance with relevant biocompatibility testing.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device and does not involve AI or machine learning models that require training data.
9. How the Ground Truth for the Training Set Was Established:
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.