(120 days)
A Powder Free Patient examination gloves 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.
White Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, white colour, powder free and non sterile.
This White Nitrile Medical Examination Gloves Powder Free 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
This document describes the regulatory submission for EMG White Nitrile Medical Examination Gloves Powder Free and does not pertain to an AI/ML device. Therefore, the questions related to AI/ML specific criteria (sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance) are not applicable.
The acceptance criteria and device performance are based on established standards for medical examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristics | Acceptance Criteria | Reported Device Performance (EMG White Nitrile Medical Examination Gloves Powder Free, K141510) |
|---|---|---|
| Product Code | LZA | LZA |
| Intended Use | A powder free 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. The device is for over-the-counter use. | Meets the stated intended use |
| Material use | Not made from Natural Rubber Latex | Nitrile latex compound |
| Colour | White | White |
| Sterility | Non sterile | Non sterile |
| Dimensions (ASTM D6319-10) | Meets ASTM D6319-10 | |
| Overall Length (mm): Min 230mm | 230min (for all sizes S, M, L, XL) | |
| Width (± 5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mm | Size S = 85, Size M = 95, Size L = 105, Size XL = 115 | |
| Thickness at Palm (mm): Min 0.05min | 0.05min (for all sizes S, M, L, XL) | |
| Thickness at Finger Tip (mm): Min 0.05min | 0.05min (for all sizes S, M, L, XL) | |
| Physical properties (ASTM D6319-10) | Meets ASTM D6319-10 | |
| Before Ageing | ||
| Tensile Strength (MPa): Min 14min | 14min | |
| Ultimate Elongation (%): Min 500min | 500min | |
| After Aging at 70°C for 168 hrs @ 100°C for 22 hrs | ||
| Tensile Strength (MPa): Min 14min | 14min | |
| Ultimate Elongation (%): Min 400min | 400min | |
| Freedom from pinholes | AQL 2.5, Inspection Level G-1 | Meets ASTM D5151-06 (which specifies AQL 2.5 for general purpose examination gloves) |
| Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 (specifies residual powder amount) |
| Biological Evaluation on Medical Device - Primary Skin Irritation Test | Test Article was non irritant | Under the conditions of this study, the test article was a non-irritant |
| Biological Evaluation on Medical Device - Dermal Sensitization Assay | Test Article was non sensitizer | Under the conditions of this study, the test article was a non-sensitizer |
2. Sample size used for the test set and the data provenance:
This information is not explicitly detailed in the provided document. The compliance is stated against ASTM standards (e.g., ASTM D6319-10 for physical properties and dimensions, ASTM D5151-06 for pinholes, ASTM D6124-06 for residual powder) which dictate the sampling plans and testing methodologies. The studies for biological evaluation (Primary Skin Irritation Test and Dermal Sensitization Assay) would also follow specific protocols to determine "non-irritant" and "non-sensitizer" classifications, likely involving in-vivo (animal) or in-vitro tests, but the sample size and data provenance are not provided in this summary.
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):
Not applicable. Ground truth for device performance (e.g., tensile strength, pinholes) is established through physical and chemical testing following standardized protocols (ASTM standards), not through expert consensus in the medical imaging sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this is not a diagnostic device requiring human interpretation of results.
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 is not an AI/ML diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is derived from objective measurements based on widely accepted international standards for medical examination gloves (ASTM D6319-10, ASTM D5151-06, ASTM D6124-06) and biological evaluation tests.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML 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.