(45 days)
Nitrile examination glove (Powder free) is a Powder free devices made of Nitrile Latex intent 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 text describes the acceptance criteria and performance data for a Nitrile Examination Glove (Powder free) manufactured by Sri.Anusham Rubber Industries Pvt. Ltd. This is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study design for an AI/Software as a Medical Device (SaMD). Therefore, many of the requested details, such as those related to AI/MRMC studies, ground truth establishment, and sample sizes for training/test sets, are not applicable or available in this document.
However, I can extract the acceptance criteria and reported device performance from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D3578 Requirement) | Reported Device Performance (SARI Value) |
|---|---|---|
| Length (EX-S) | 220 mm minimum | 235-240 mm |
| Length (S) | 220 mm minimum | 235-240 mm |
| Length (M) | 230 mm minimum | 235-240 mm |
| Length (L) | 230 mm 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 (all sizes) | 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 |
| Dimension (AQL) | 4 | 4 |
| Physical Property (AQL) | 4 | 4 |
| Powder Content | 2 mg/glove max | Nil Powder (later reported as 1 +/- 1 mg per glove) |
| Protein Content | Value not fixed | "Value not fixed" (later reported as 30 +/- 10 ppm) |
| Moisture Content | Value not fixed | 0.8% max |
| Biocompatibility | Biologically Compatible | Biologically Compatible |
Summary of Device Performance against Acceptance Criteria:
The "Conclusion of Performance Test Data" section explicitly states that the Nitrile Examination gloves manufactured by Sri. Anusham Rubber Industries Pvt. Ltd.:
- "Meet or exceed the ASTM D3578"
- "Meet FDA Pin hole Requirement."
- "Meet labelling claim as shown by the data"
Based on the tables above, the reported device performance values generally meet or exceed the specified ASTM D3578 requirements. For example, length, thickness, tensile strength, and elongation are all within or above the minimum requirements. Width values are also largely within the +/- 6mm tolerance. The AQL for "Freedom from Holes" (1.5) is better (lower AQL indicates better quality) than the ASTM requirement (4). Powder content is reported as "Nil Powder" initially, and then "1 +/- 1 mg per glove", both of which are within the "2 mg/glove max" requirement. Protein content and moisture content, for which ASTM requirements were "Value not fixed," have reported values. Biocompatibility is also stated to be compatible with FDA requirements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample size used for testing each characteristic. The "Level followed By SARI" for "Freedom from Holes," "Dimension," and "Physical Property" refers to inspection levels (S4, S2), which are part of a sampling plan (e.g., as per ISO 2859-1 or military standard 105E). These levels determine the severity of sampling, but not the absolute number of units tested.
- Data Provenance: The manufacturing company is M/s. SRI.ANUSHAM RUBBER INDUSTRIES PVT.LTD. in Tamil Nadu, India. The performance data is stated to be for gloves "manufactured by SRI ANUSHAM RUBBER INDUSTRIES PVT.LTD." This indicates the data is from tests performed on their products, likely at their facility or a contracted lab in India. The study is a prospective test of their manufactured products against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to the provided document. The "ground truth" here is defined by objective physical and chemical measurements governed by the ASTM D3578 standard, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. As the "ground truth" is based on objective measurements against a standard, there is no expert adjudication process described.
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 section is not applicable. The device is a physical medical glove and does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical medical glove and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for performance evaluation is based on objective measurements against an established international standard (ASTM D3578-95) for "Standard Specification for Rubber Examination Gloves." This standard defines acceptable physical properties, dimensions, and other characteristics.
8. The sample size for the training set
This section is not applicable. The document describes a physical product and its testing against a standard, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable. See point 8.
§ 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.