(107 days)
Medical Nitrile 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.
The proposed device is a powder free medical glove. The device is blue in color. The device meets the requirements of ASTM D6319-19: Standard specification for Nitrile Examination Gloves for Medical Application. The proposed gloves are available in six sizes, which are XS, S, M, L, XL, XXL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
The provided text describes the 510(k) summary for "Medical Nitrile Examination Gloves" (K212014) and its comparison to a predicate device (K172015). This document focuses on the glove's physical and biological properties rather than a software or AI-driven medical device. Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in this context pertains to the performance of the physical glove based on industry standards and biocompatibility, not an algorithmic performance study typical of AI/ML medical devices.
The request asks for specific details relevant to AI/ML device studies (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance). These are not applicable to the evaluation of a physical medical glove.
However, I can extract and present the information provided in the document in a format that aligns with the spirit of the request, interpreting "acceptance criteria" and "study" in the context of a physical device's non-clinical testing.
Device: Medical Nitrile Examination Gloves (K212014)
Device Type: Physical medical device (not an AI/ML algorithm)
Given that the device is a physical glove and not an AI/ML system, many of the requested points are not applicable. I will address the relevant points based on the provided document and explicitly state when a point is not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents non-clinical test results demonstrating compliance with various ASTM and ISO standards for medical gloves.
| Test Method | Purpose | Acceptance Criteria (from standard) | Reported Device Performance (Results) |
|---|---|---|---|
| Freedom from Holes - ASTM D5151-19 | Detection of holes that allow water leakage | Do not show droplet, stream or other type of water leakage (AQL 2.5 was adopted, as stated elsewhere in the document, which means a certain percentage of defects is acceptable per lot) | No leakage |
| Physical Dimension - ASTM D6319-19 | Evaluate the glove physical dimension | Length: >220 mm (XS and S sizes); >230 mm (M, L, XL and XXL sizes) | |
| Width (±10mm): XS = 70mm, S = 80mm, M = 95mm, L = 110mm, XL = 120mm, XXL = 130mm | |||
| Thickness at Finger: All Sizes ≥ 0.05 mm | |||
| Thickness at Palm: All Sizes ≥ 0.05 mm | Length: Larger than 220mm for XS and S size; Larger than 230mm for M, L, XL and XXL sizes | ||
| Width: XS: within 75±5mm, S: within 85±5mm, M: within 95±5mm, L: within 115±5mm, XL: within 125±5mm, XXL: within 135±5mm (Note: The reported results for width are slightly different than the criteria listed for predicate, but stated they meet ASTM D6319-19 requirements, which has a wider acceptable range for width compared to the predicate's stated criteria). | |||
| Thickness: Larger than 0.05mm | |||
| Physical Requirement - ASTM D412-16 | Evaluate the physical requirement (Tensile Strength, Ultimate Elongation) | Before Aging (Min): Tensile strength: 14Mpa, Ultimate elongation: 500% | |
| After Aging (Min): Tensile strength: 14Mpa, Ultimate elongation: 400% | Before aging: Larger than 14Mpa and 500% | ||
| After aging: Larger than 14Mpa and 400% | |||
| Powder Residue - ASTM D6124-06 | Evaluate the residue powder | Less than 2.0mg per glove | Less than 2.0mg |
| Skin Sensitization - ISO 10993-10 | Evaluated for the potential to cause delayed dermal contact sensitization | Non-sensitizing | No skin sensitization |
| Skin Irritation - ISO 10993-10 | Evaluated for the potential to cause skin irritation | Non-irritating | No skin irritation |
| Acute Toxicity - ISO 10993-11 | Evaluated for acute systemic toxicity | Non-acute systemic toxic | No acute toxicity |
Points Not Applicable to a Physical Device (Medical Nitrile Examination Gloves):
The following points are primarily relevant to software or AI/ML-driven medical devices and are not applicable to the evaluation of a physical product like examination gloves:
- Sample sized used for the test set and the data provenance: Not applicable. Tests are conducted on physical glove samples as per standard quality control procedures for manufacturing, not "data" test sets. The document indicates the manufacturer is in China (Jiangxi Ronglai Medical Technology Co., Ltd. - NO.666 Baixu Street, Baixu town, Jinxian County, Nanchang City, Jiangxi Province, China).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for glove performance is established by meeting specified physical and chemical properties defined by international standards (ASTM, ISO), not by expert human interpretation.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against quantitative and qualitative standards.
- 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 for AI-assisted image interpretation, not physical devices.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI algorithms.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI. For this physical device, "ground truth" is defined by the technical specifications and testing methodologies outlined in the referenced ASTM and ISO standards.
- The sample size for the training set: Not applicable. This is for AI algorithms.
- How the ground truth for the training set was established: Not applicable. This is for AI algorithms.
Summary of the Study for Medical Nitrile Examination Gloves:
The "study" in this context refers to a series of non-clinical tests performed on the Medical Nitrile Examination Gloves to ensure they meet the established performance and safety criteria for medical examination gloves. These tests adhere to recognized international standards (ASTM D6319-19, ASTM D5151-19, ASTM D3767-03, ASTM D412-16, ASTM D6124-06, ISO 10993-10, ISO 10993-11). The results demonstrated that the device complies with these standards for properties such as freedom from holes, physical dimensions (length, width, thickness), physical requirements (tensile strength, ultimate elongation before and after aging), powder residue, and biocompatibility (skin irritation, skin sensitization, acute systemic toxicity). The conclusion drawn is that the device is as safe and effective as the legally marketed predicate device (K172015). No clinical study was performed or deemed necessary 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.