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510(k) Data Aggregation
(93 days)
Disposable Medical Nitrile Examination Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile). The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I) for single use only. The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided document is a 510(k) Premarket Notification for Disposable Medical Nitrile Examination Gloves (Non-Sterile). This type of document is for a medical device that does not use AI/ML, and therefore, the requested information regarding AI/ML device performance and related study details is not applicable.
However, I can extract the acceptance criteria and performance data for this device based on the non-clinical testing summary provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance/Result |
|---|---|---|---|
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width:80mm ±10mm (for small size)95mm ±10mm (for medium size)110 mm ±10mm (for large size)Length:220 mm (Minimum) (for small size)230 mm (Minimum)(for medium, large size)Thickness:Finger -0.05 mm (Minimum) (for small, medium, large size)Palm -0.05 mm (Minimum)(for small, medium, large size) | Width:small size: 82 to 89mmmedium size: 91 to 96mmlarge size: 115 to 116mmLength:small size: 230mm (minimum)medium size: 240mm (minimum)large size: 238mm (minimum)Thickness:Finger:small size: 0.12mm (minimum)medium size: 0.13mm (minimum)large size: 0.12mm (minimum)Palm:small size: 0.08 mm (minimum)medium size: 0.08mm (minimum)large size: 0.09 mm (minimum)Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test | To determine the tensile strength and ultimate elongation before and after acceleration aging | Before Acceleration Aging:Tensile Strength (MPa): 14 (Minimum)Ultimate Elongation (%): 500 (Minimum)After Acceleration Aging:Tensile Strength (MPa): 14 (Minimum)Ultimate Elongation (%): 400 (Minimum) | Before Acceleration Aging:Tensile Strength (MPa): 20 (Minimum)Ultimate Elongation (%): 521 (Minimum)After Acceleration Aging:Tensile Strength (MPa): 19 (Minimum)Ultimate Elongation (%): 505 (Minimum)Passed |
| ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | (Mean) AQL 2.5 | Passed |
| ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | < 2.0 mg/glove | 0.33 mg/glove, Passed |
| ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin irritation and skin sensitization | To determine the potential of the material under test to produce skin irritation in rabbits | Under the condition of study, testing articles are not an irritant | Under the conditions of study, the test article did not show significant evidence of causing skin sensitization in the guinea pig. (Note: Result listed under the "irritation" row in the document is the sensibility test result for the guinea pig). |
| ISO 10993-10 Biological evaluation of medical devices — Part 10: Tests for skin irritation and skin sensitization | To determine the skin sensitization potential of the material both in terms of induction and elicitation in guinea pigs. | Under the conditions of the study, the testing articles are not a sensitizer. | Under the conditions of the study the sample did not induce skin irritation. (Note: Result listed under the "sensitization" row in the document is the irritation test result). |
| ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity | To evaluate the in vitro cytotoxic potential of the test item (both inner and outer surface) Extracts in L-929 mouse fibroblasts cells using elution method | Under the conditions of study, no more than grade 2 cytotoxic reaction | Mild (Grade 2) cytotoxicity reaction observed. Passed. |
Since this document describes a Class I medical device (Disposable Medical Nitrile Examination Gloves), which is a low-risk device, the requirements for its acceptance parallel those of general product testing and biocompatibility, as opposed to complex AI/ML algorithms. Therefore, the following points regarding AI/ML specific study information are not applicable to this submission:
- Sample sizes used for the test set and the data provenance: Not applicable. Testing involves physical properties and biocompatibility, not data sets for an AI model.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves (e.g., tensile strength, freedom from holes) is established through standardized physical and chemical testing, not expert interpretation of AI outputs.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device is based on established material science and biological testing standards (e.g., ASTM and ISO standards) which define performance metrics for physical properties (e.g., length, width, thickness, tensile strength, elongation), chemical properties (e.g., powder residue), and biological responses (e.g., skin irritation, sensitization, cytotoxicity).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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