(83 days)
EXAMINATION GLOVE (POWDERED) IS A DISPOSABLE DEVICE MADE OF NATURAL LATEX INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINERS HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER AND IS POWDERED WITH A DONNING POWDER ABSORBABLE USP CORN STARCH.
Class I Patient Examination Gloves (powdered) 80L that meets all 'the requirements of ASTM D3578.
Here's the breakdown of the acceptance criteria and study information for the Latex Examination Gloves (Powdered) from Brightway Gloves Pvt. Ltd., as extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | SIZE | Acceptance Criteria (ASTM D3578) | Reported Performance (BGPL 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 | |
| Tensile Strength (Before Ageing) | N/A | 14 mpa min | 20 - 22 mpa | Yes |
| Elongation at break % (Before Ageing) | N/A | 700% min | 800 - 850% | Yes |
| Tensile Strength (After Ageing) | N/A | 14 mpa min | 18 – 20 mpa | Yes |
| Elongation at break % (After Ageing) | N/A | 500% min | 750-800% | Yes |
| Freedom from Holes (AQL) | N/A | 4 | 1.5 (Reported as 'followed by BGPL', lower AQL is better) | Yes |
| Dimension (AQL) | N/A | 4 | 4 | Yes |
| Physical Property (AQL) | N/A | 4 | 4 | Yes |
| Powder Content | N/A | Not explicitly stated in table, but noted in "Conclusion" | 120 +/- 20 mg per glove | Yes (implied by conclusion) |
| Protein Content | N/A | Not explicitly stated in table, but noted in "Conclusion" | 80 +/- 20 ppm | Yes (implied by conclusion) |
| Moisture Content | N/A | Not explicitly stated in table, but noted in "Conclusion" | 0.8% max | Yes (implied by conclusion) |
| Biocompatibility | N/A | Not explicitly stated in table, but noted in "Conclusion" | Biologically Compatible | Yes (implied by conclusion) |
| Pin hole Requirement | N/A | FDA Pin hole Requirement | Not explicitly quantified, but stated "Meet FDA Pin hole Requirement" | Yes |
Note: For characteristics like Powder Content, Protein Content, Moisture Content, and Biocompatibility, no specific ASTM D3578 numerical requirement was explicitly listed in the tables provided for direct comparison. However, the "Conclusion of Performance Test Data" explicitly states that the gloves "Meet or exceed the ASTM D3578" and "Meet FDA Pin hole Requirement" and "Meet labelling claim," implying that the stated performance values for these attributes align with the relevant standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set for each parameter. It lists the measured values for various glove sizes and properties. The data provenance is from India (manufacturer is M/s. BRIGHTWAY GLOVES PVT.LTD. in Tamil Nadu, India). The study appears to be retrospective in the sense that it presents the results of tests already conducted (e.g., "The performance test data... given below").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a medical device (patient examination gloves) that is evaluated against established technical standards (ASTM D3578) and regulatory requirements (FDA pinhole requirement). The ground truth is objective measurement data against these standards, not expert interpretation of subjective information.
4. Adjudication Method for the Test Set
N/A. As mentioned above, the determination is based on objective measurements against predefined standards, not subjective assessments 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
N/A. This is a physical medical device (gloves), not an AI-powered diagnostic or interpretive system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for this device is based on established industry standards and regulatory requirements, specifically:
- ASTM D3578 (Standard Specification for Rubber Examination Gloves)
- FDA Pinhole Requirement
These provide objective benchmarks for physical, chemical, and performance properties.
8. The sample size for the training set
N/A. This is a physical medical device. The concept of a "training set" is relevant for AI algorithms, not for the manufacturing and testing of examination gloves. The product undergoes quality control and testing against specifications, not machine learning model training.
9. How the ground truth for the training set was established
N/A. As above, the concept of a "training set" and its ground truth establishment is not applicable to 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.