(83 days)
EXAMINATION GLOVES POWDER FREE IS A POWDER FREE LATEX DISPOSABLE DEVICE MADE OF NATURAL RUBBER LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND ob eximali contrail contrainer time between batten and EXAMINER.
Class I Patient Examination Gloves Latex (Powder free) 80L Y Y that meets all the requirements of ASTM D3578
The device is a Latex Examination Glove (Powder free) manufactured by Brightway Gloves Pvt. Ltd., intended for medical purposes to prevent contamination between patients and examiners. The acceptance criteria and performance data are detailed below, comparing the device's characteristics against ASTM D3578 requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Size | Acceptance Criteria (ASTM D3578 Requirement) | Reported Device Performance (Brightway Gloves 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 | EX S | 0.08 mm minimum | 0.10 mm | Yes |
| S | 0.08 mm minimum | 0.10 mm | Yes | |
| M | 0.08 mm minimum | 0.10 mm | Yes | |
| L | 0.08 mm minimum | 0.10 mm | Yes | |
| Physical Properties (Before Ageing) | ||||
| Tensile Strength | 14 mpa min | 20 - 22 mpa | Yes | |
| Elongation at break % | 700% min | 750 - 800% (or 750-850% in performance data) | Yes | |
| Physical Properties (After Ageing) | ||||
| Tensile Strength | 14 mpa min | 18 - 20 mpa | Yes | |
| Elongation at break % | 500% min | 700 - 800% | Yes | |
| Performance Requirement | ||||
| Freedom from Holes | Holes | AQL 4 | AQL 1.5 | Yes (lower AQL is better) |
| Dimension | Width, Length, Thickness | AQL 4 | AQL 4 | Yes |
| Physical Property | Tensile Strength, Elongation at Break | AQL 4 | AQL 4 | Yes |
| Powder Content | Not explicitly stated in ASTM D3578, but implied by "powder free" | 1 +/- 1 mg per glove | N/A (meets "powder free" claim) | |
| Protein Content | Not explicitly stated in ASTM D3578 | 80 +/- 20 ppm | N/A | |
| Moisture Content | Not explicitly stated in ASTM D3578 | 0.8% max | N/A | |
| Biocompatibility | Not explicitly stated in ASTM D3578 | Biologically Compatible | N/A (meets general expectation) |
2. Sample size used for the test set and the data provenance
The document states that the performance test data is for "Latex Examination Glove powder free manufactured by M/S Brightway Gloves Pvt.Ltd." However, the sample size used for these tests is not explicitly stated in the provided document. The data provenance is
retrospective by the manufacturer, Brightway Gloves Pvt. Ltd., located in Tamil Nadu, India.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the physical and performance properties of the gloves is established by the ASTM D3578 standard specifications. No human expert "ground truthing" is mentioned or implied for these types of measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a measurement of physical and performance characteristics against a standard, not a subjective assessment requiring adjudication among experts.
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 device is a Latex Examination Glove, not an AI or diagnostic medical device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a Latex Examination Glove, not an AI or algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth is based on the ASTM D3578 standard specifications for Latex Examination Gloves. These are established industry standards for the physical and performance characteristics of such gloves.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.