(42 days)
Nitrile Examination Gloves Powder free is a powder free 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 Nitrile Examination Gloves ( Powder free) 80LZA that meets all the requirements of ASTM D3578- 95.
The provided documents describe a 510(k) submission for Nitrile Examination Gloves (Powder-free) manufactured by Shiva Medicare Limited, seeking to demonstrate substantial equivalence to a predicate device. This submission is for a Class I medical device, which typically does not involve complex AI algorithms or extensive clinical studies in the same way higher-risk devices might.
Based on the provided information, the acceptance criteria and study proving the device meets these criteria are focused on physical characteristics and performance of the examination gloves, aligning with ASTM D3578-95 standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D3578-95 Requirement) | Reported Device Performance (Shiva Medicare Ltd.) |
|---|---|---|
| Length (EX-S, S) | 220 mm minimum | 235-240 mm |
| Length (M, L) | 230mm minimum | 235-240 mm |
| Width (EX-S) | 70 +/- 6 mm | 70 mm |
| Width (S) | 80 +/- 6 mm | 82 mm |
| Width (M) | 95 +/- 6 mm | 93 mm |
| Width (L) | 111 +/- 6 mm | 107 mm |
| Thickness | 0.08 mm minimum | 0.10 mm |
| Tensile Strength (Before Ageing) | 14 mpa min | 18-20 mpa |
| Elongation at Break % (Before Ageing) | 700% min | 750-800% |
| Tensile Strength (After Ageing) | 14 mpa min | 16-18 mpa |
| Elongation at Break % (After Ageing) | 500% min | 650-700% |
| Freedom from Holes (AQL) | 4 | 1.5 (SML) |
| Dimension (AQL) | 4 | 4 (SML) |
| Physical Property (AQL) | 4 | 4 (SML) |
| Powder Content | Not explicitly stated in ASTM D3578 section, but implied by "Powder-free" description. | 1 +/- 1 mg per glove |
| Protein Content | Not explicitly stated in ASTM D3578 section. | 30 +/- 10 ppm |
| Moisture Content | Not explicitly stated in ASTM D3578 section. | 0.8% max |
| Biocompatibility | Not explicitly stated in ASTM D3578 section. | Biologically Compatible |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size: The document does not explicitly state the specific number of gloves tested for each characteristic. It refers to "Measured Parameters" and "Performance Data" but does not detail the statistical sampling plan (e.g., how many gloves from how many batches were tested). The AQL (Acceptable Quality Level) values (S4, S2) mentioned imply a standardized sampling plan used for quality control, but the exact sample sizes are not provided within this document.
- Data Provenance: The data is generated by the manufacturer, Shiva Medicare Limited, in India ("A 15, 16, 17(PART) MADRAS EXPORT PROCESSINGZONE KADAPERI, TAMBARAM, CHENNAI 600 045. INDIA."). The nature of the tests (physical and chemical properties) indicates that the data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective, measurable physical and chemical properties as defined by international standards (ASTM D3578-95). There is no "expert consensus" required for dimensions, tensile strength, or elongation at break; these are determined by laboratory measurements.
4. Adjudication Method for the Test Set:
This is not applicable. As stated above, the device performance is measured against objective, predetermined standards (ASTM D3578-95). There is no "adjudication" process in the sense of multiple human experts reviewing and deciding on a finding. The measurements either meet the specification or they don't.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This is a physical product (examination gloves), not an AI-powered diagnostic device or an imaging product that would involve human readers interpreting cases. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This device is an examination glove, a physical product, not an algorithm or software. Therefore, standalone performance evaluation of an algorithm is not applicable.
7. The Type of Ground Truth Used:
The ground truth used is objective, measurable physical and chemical properties as defined by the ASTM D3578-95 international standard for rubber examination gloves. This standard sets the quantitative requirements for these properties.
8. The Sample Size for the Training Set:
Not applicable. This dossier describes a traditional medical device (gloves), not an AI/ML-based device. There is no "training set" in the context of machine learning. The "training" in manufacturing refers to process control and quality system implementation.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no AI/ML component, there is no "training set" or "ground truth for the training set" as defined in the context of AI. The product is manufactured and tested according to established quality control procedures against predefined standards.
§ 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.