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510(k) Data Aggregation
(54 days)
The NITRILE EXAMINATION GLOVES is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is white, cobalt blue, black, blue. It can be available in six specifications: S, M, L, XL. The subject device is non-sterile.
This document is a 510(k) Premarket Notification for Nitrile Examination Gloves, a Class I medical device. The information provided is specifically for proving the substantial equivalence of these gloves to a legally marketed predicate device.
Therefore, the request for acceptance criteria and study details related to AI/ML-based medical devices using concepts like "human readers improve with AI vs without AI assistance," "standalone algorithm performance," "number of experts," "adjudication method," and "training set size and ground truth" are not applicable to this document.
This document describes the performance of the physical glove itself, not a software algorithm.
Here's a breakdown of the requested information based on the provided document, highlighting why most of the AI/ML-related questions are irrelevant:
1. A table of acceptance criteria and the reported device performance
The document provides this information clearly in "Table 2 - Summary of non-clinical performance testing" on pages 6-9.
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm):- S: ≥ 220- M/L/XL: ≥ 230Width (mm):- S: 80 ± 10- M: 95 ± 10- L: 110 ± 10- XL: 120 ± 10 | Length (mm):- S: ≥ 220- M/L/XL: ≥ 230.Width (mm):- White: S: 85-88/Pass, M: 96-98/Pass, L: 106-108/Pass, XL: 114-117/Pass- Cobalt Blue: S: 83-86/Pass, M: 95-99/Pass, L: 105-109/Pass, XL: 113-117/Pass- Black: S: 85-87/Pass, M: 95-98/Pass, L: 104-107/Pass, XL: 114-117/Pass- Blue: S: 84-86/Pass, M: 96-102/Pass, L: 104-107/Pass, XL: 114-116/PassThickness (mm):- Finger: White: 0.07-0.11/Pass, Cobalt Blue: 0.10-0.14/Pass, Black: 0.14-0.16/Pass, Blue: 0.09-0.11/Pass- Palm: White: 0.05-0.07/Pass, Cobalt Blue: 0.08-0.10/Pass, Black: 0.11-0.13/Pass, Blue: 0.07-0.08/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | White: 0.20-0.24mg/Pass; Cobalt Blue: 0.21-0.24mg/Pass; Black: 0.17-0.22mg/Pass; Blue: 0.16-0.19mg/Pass |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Tensile Strength: White: 19-24MPa, Cobalt Blue: 19-26MPa, Black: 17-22MPa, Blue: 20-24MPaUltimate Elongation: White: 500-528%, Cobalt Blue: 517-633%, Black: 527-642%, Blue: 501-598% |
| ASTM D412 | Physical properties (After Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | Tensile Strength: White: 14-22MPa, Cobalt Blue: 18-24MPa, Black: 14-20MPa, Blue: 15-23MPaUltimate Elongation: White: 400-488%, Cobalt Blue: 489-578%, Black: 500-598%, Blue: 471-561% |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is not cytotoxic / Pass |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity in vivo | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer./ Pass |
Regarding the AI/ML-specific questions (2-9):
These questions are designed for evaluating AI/ML-based medical devices or diagnostic software. This 510(k) submission is for a physical device (nitrile examination gloves) and does not involve AI/ML technology, image analysis, computer vision, or diagnostic algorithms. Therefore, the concepts of "test set," "training set," "experts creating ground truth," "adjudication," or "human-in-the-loop performance" are not applicable.
The "study" referenced in this document refers to non-clinical performance testing of the physical glove's properties and biocompatibility, as outlined in the tables above.
Here's why each specific AI/ML question is not applicable:
- Sample sizes used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an AI/ML model. The "samples" are physical gloves subjected to laboratory tests. The provenance is likely from the manufacturing facility (Vietnam, as per submitter info).
- 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 physical properties (e.g., tensile strength, dimensions) is established by standardized testing methods (e.g., ASTM, ISO) and laboratory equipment, not by human experts interpreting data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This applies to human consensus on complex interpretations, not objective physical measurements.
- 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 diagnostic tools.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "ground truth" for glove performance is defined by the acceptance criteria of the relevant ASTM and ISO standards for physical properties and biocompatibility (e.g., a specific tensile strength value, AQL for holes, non-cytotoxicity as per ISO 10993-5).
- The sample size for the training set: Not applicable. There is no "training set" as this is not a learning algorithm.
- How the ground truth for the training set was established: Not applicable.
In conclusion, this 510(k) submission successfully demonstrates that the Nitrile Examination Gloves meet the required performance standards for their intended use through standard physical and biocompatibility testing, proving substantial equivalence to the predicate device. The framework of questions provided is not suitable for this type of medical device submission.
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