(195 days)
The Powder free Nitrile Examination Gloves (Blue, White, Cobalt Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Powder Free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Violet Blue, White, and Cobalt Blue.
The proposed device is not provided as sterilized
This document is a 510(k) Pre-Market Notification for Powder free Nitrile Examination Gloves. The acceptance criteria and the study proving the device meets these criteria are detailed in the "Performance and Physical Specifications" table (Table 2) on page 5, and the "Performance Comparison" table (Table 3) on pages 6-7, supported by non-clinical bench tests.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (ASTM D6319-15) | Reported Device Performance (Powder free Nitrile Examination Gloves - Proposed Device) |
|---|---|
| Pinhole AQL | 1.5 |
| Before Aging | |
| Tensile Strength | 14 MPa, min |
| Ultimate Elongation | 500 % min |
| After Aging | |
| Tensile Strength | 14 MPa, min |
| Ultimate Elongation | 400 % min |
| Fulfill ASTM D6319 | Comply with ASTM D6319 |
| Freedom from Holes | Be free from holes when tested in accordance with ASTM D5151 |
| Powder Content | Less than 2 mg per glove when tested in accordance with ASTM D6124 |
| Biocompatibility | |
| Irritation and Sensitization | Under the conditions of the study, not an irritant and not a sensitizer |
| Cytotoxicity | Under conditions of the study, not cytotoxic |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size used for the test set for each specific test (e.g., tensile strength, pinholes). However, the testing was conducted according to recognized ASTM and ISO standards, which typically specify sampling plans. The data provenance is from non-clinical bench tests performed to verify the device's compliance with design specifications and relevant standards. The country of origin of the data is implied to be related to the manufacturer in Vietnam or the testing facilities they utilized. The studies are prospective as they were specifically conducted for this 510(k) submission.
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 is not applicable for this type of device and study. The "ground truth" for performance of examination gloves is established by quantitative measurements according to standardized test methods (ASTM and ISO standards), not by expert opinion.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As described above, performance is determined by objective measurements using standardized test methods.
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 an examination glove, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an examination glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance of the examination gloves is based on established industry standards and test methods (ASTM D6319-15, ASTM D5151-06, ASTM D6124-17, ISO 10993-10:2010, ISO 10993-5:2009). These standards define the acceptable physical properties, barrier integrity, and biocompatibility of medical examination gloves.
8. The sample size for the training set
Not applicable. This device is an examination glove, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this 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.