(18 days)
Latex examination glove (Powder free) is a Powder free device 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 Latex ( Powder free) 80LYY that meets all 'the requirements of ASTM D3578- 95.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Shiva Medicare Limited Latex Examination Gloves (Powder free):
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3578) | Reported Device Performance (SML Value) | Meets Criteria? |
|---|---|---|---|
| Length | |||
| EX-S | 220 mm minimum | 235-240 mm | Yes |
| S | 220 mm minimum | 235-240 mm | Yes |
| M | 230 mm minimum | 235-240 mm | Yes |
| L | 230 mm minimum | 235-240 mm | Yes |
| Width | |||
| EX-S | 70 +/- 6 mm | 70 mm | Yes |
| S | 80 +/- 6 mm | 82 mm | Yes |
| M | 95 +/- 6 mm | 93 mm | Yes |
| L | 111 +/- 6 mm | 107 mm | Yes |
| Thickness | 0.08 mm minimum | 0.10 mm | Yes |
| Tensile Strength | |||
| Before Ageing | 14 mpa min | 20 - 22 mpa | Yes |
| After Ageing | 14 mpa min | 18 - 20 mpa | Yes |
| Elongation at Break % | |||
| Before Ageing | 700% min | 750 - 850% | Yes |
| After Ageing | 500% min | 700-800% | Yes |
| Freedom from Holes | AQL 4 | AQL 1.5 | Yes (Better) |
| Dimension | AQL 4 | AQL 4 | Yes |
| Physical Property | AQL 4 | AQL 4 | Yes |
| Powder Content | Not explicitly stated (implied "Powder-free") | 1 +/- 1 mg per glove | Yes |
| Protein Content | "value not fixed" | 80 +/- 20 ppm | N/A (meets SML reported value) |
| Moisture Content | Not explicitly stated | 0.8% max | Yes |
| Biocompatibility | Biologically Compatible | Biologically Compatible | Yes |
Summary of Device Performance: The Shiva Medicare Limited Latex Examination Gloves (Powder free) meet or exceed all the specified acceptance criteria from ASTM D3578-95 and FDA pinhole requirements, as reported in the Conclusion of Performance Test Data.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "Performance test data of the powder free examination glove manufactured by Shiva Medicare Limited" but does not detail the number of units tested for each characteristic. It mentions AQL (Acceptance Quality Limit) levels (S4, S2) which implies a sampling plan, but the specific sample sizes used per test are not provided.
- Data Provenance: The data is generated by Shiva Medicare Limited, located in India (Madras Export Processing Zone, Chennai). The data is prospective as it's presented as the performance of the manufactured device tested against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This study is a performance test of a medical device against established industry standards (ASTM D3578-95) and regulatory requirements (FDA pinhole requirement). Ground truth here is defined by these pre-existing technical specifications, not by expert consensus on individual "cases" or "images."
- There were no "experts" establishing a case-by-case ground truth in the traditional sense of a diagnostic study. The "ground truth" is the published standard.
4. Adjudication method for the test set
- Not Applicable. As explained above, this is a product performance test against predefined technical standards. There is no adjudication of findings between multiple reviewers as would be seen in clinical image interpretation studies. The measurements are objective physical properties.
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
- No. This is a performance study for a physical medical device (gloves), not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a performance study for a physical medical device (gloves), not an algorithm. This concept does not apply.
7. The type of ground truth used
- The ground truth used is a combination of:
- Expert Consensus/Standard: The established international standard ASTM D3578-95 for Latex Examination Gloves. ASTM standards are developed through a consensus process involving experts in the field.
- Regulatory Requirement: "FDA Pinhole Requirement."
8. The sample size for the training set
- Not Applicable. This is a performance study for a physical medical device (gloves), not a machine learning model. Therefore, there is no "training set" in this context. The product is manufactured and then tested to ensure it meets specifications.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for a machine learning model, this question does not apply.
§ 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.