(162 days)
Disposable Nitrile Examination Gloves is a non-sterile 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 Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided text describes the non-clinical testing performed for a Class I medical device, "Disposable Nitrile Examination Gloves" (K211073). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the efficacy of an AI/ML algorithm. Therefore, many of the requested bullet points, particularly those related to AI algorithm performance, human-in-the-loop studies, and ground truth establishment for training sets, are not applicable to this document.
However, I can extract the relevant information regarding the acceptance criteria and study results for this specific device.
Acceptance Criteria and Device Performance for Disposable Nitrile Examination Gloves (K211073)
The provided document details non-clinical tests conducted to verify the safety and performance of the "Disposable Nitrile Examination Gloves" (K211073) against established standards and to demonstrate substantial equivalence to a predicate device (K181106).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| In Vitro Cytotoxicity Test (Agar diffusion Method) (ISO 10993-5:2009) | Determine potential cytotoxicity to mammalian cell cultures (mouse fibroblast L-929 cells). | The test sample met the requirements if the biological response was less than or equal to grade 2. | Under the conditions of this study, the test article was Slight cytotoxic and was accepted in the agar diffusion method. |
| Skin Sensitization Test (Guinea Pig Maximization) (ISO 10993-10:2010) | Evaluate potential for the test article to cause skin sensitization. | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. If the response is equivocal, rechallenge is recommended to confirm the results from the first challenge. The outcome of the test is presented as the frequency of positive challenge results in test and control animals. | The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. |
| Skin Irritation Test (Extraction Method) (ISO 10993-10:2010) | Evaluate potential skin irritation caused by test article contact with skin surface of rabbits. | When blank or negative control was used, calculate the primary irritation score for the controls and subtract that score from the score using the test material to obtain the primary irritation score. | The test result showed that the response of the test article extract was categorized as negligible under the test condition. |
| Acute Systemic Toxicity Test (Extraction Method) (ISO10993-11:2017) | Evaluate potential acute systemic toxicity caused by test article contact in ICR mice. | Within the monitoring period (72 h), if the toxicosis response of testing group is not greater than that of control group, the testing sample is regarded as acceptable. In case that two or more mice show the medium toxicosis symptom or die, the testing sample is regarded as unacceptable. If any animals treated with the sample show only slight signs of biological reactivity, and not more than one animal shows gross symptoms of biological reactivity or dies, repeat the testing using groups of 10 animals. On the repeat test, if all 10 animals treated with the sample show no scientifically meaningful biological reactivity above the vehicle control animals during the observation period, the sample meets the requirements of this test. | The test article showed no evidence of causing acute system toxicity in the ICR mice. |
| Watertightness Test for Detection of Holes (ISO 2859-1:1999, ASTM D6319-19, ASTM D5151-19) | Validate integrity of the glove to prevent holes. | Items: Water lack, Batch size: 35000, Inspectional level: I, AQL: 2.5, Sample Demand: 125, Criterion: ≤7 non-conforming gloves. | Number of Conforming: 125 Glove, Number of Non-conforming: 0 Glove |
| Physical Dimensions Test (ISO 2859-1:1999, ASTM D6319-19, ASTM D3767-03(2014)) (Includes Length, Width, Thickness as per Table 1) | Ensure dimensional conformity to standard (ASTM D6319-19). | Items: Physical dimension test, Batch size: 35000, Inspectional Level: S-2, AQL: 4.0, Sample Demand: 13. (Specific ranges for Length, Width, Thickness are provided in Table 1, and the acceptance indicates compliance with ASTM D6319-19 for these.) | The test result was considered to be acceptable. (Specific measurements are listed in Table 1, matching or exceeding ASTM D6319-19 requirements) |
| Determination of Physical Properties (ISO 2859-1:1999, ASTM D6319-19, ASTM D412-06a(2013)) (Includes Tensile Strength and Ultimate Elongation as per Table 1) | Validate mechanical properties of the glove (tensile strength, elongation) both before and after aging. | Items Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500%. After Accelerated Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥400%. Batch size: 35000, Inspectional Level: S-2, AQL: 4.0, Sample Demand: 13, Number of Non-conforming: ≤1. | The test result was considered to be acceptable. (Specific measured ranges provided in Table 1: Before Aging Tensile Strength 15.3-23.4 MPa, Ultimate Elongation 500.972-595.086%; After Aging Tensile Strength 14.1-30.6 MPa, Ultimate Elongation 416.106-601.187%) |
| Surface Powder Test of "powder-free" gloves (ASTM D6319-19, ASTM D573-04(2015), ISO 21171-2006, ASTM D6124-06(2017)) | Quantify residual powder on the gloves to ensure "powder-free" claim. | Analyte: Residual Powder, Powder-free Synthetic Exam (3 sets of 2 gloves/batch, Average: 0.63mg/glove - this appears to be a reference/predicate value or goal, as the acceptance isn't explicitly stated as a limit from the provided text). | Result: 0.18mg/glove. The results showed each property of the test glove was acceptable under this test condition. |
2. Sample Size Used for the Test Set and Data Provenance
- Cytotoxicity, Skin Sensitization, Skin Irritation, Acute Systemic Toxicity: Sample sizes are not explicitly stated as numerical values for these biological tests but refer to "test article" which implies sufficient samples as per the respective ISO standards. The data provenance is not specified beyond being part of the submission for a Chinese manufacturer; presumably, the tests were conducted under controlled laboratory conditions, not on human patients or retrospectively/prospectively collected clinical data.
- Watertightness Test:
- Sample Demand: 125 gloves
- Batch size: 35,000 gloves (for lot-by-lot inspection, implies the sample is drawn from a manufacturing lot)
- Provenance: Not specified, but generally implies in-house or contracted lab testing for manufacturing batches.
- Physical Dimensions Test:
- Sample Demand: 13 gloves
- Batch size: 35,000 gloves
- Provenance: Not specified.
- Determination of Physical Properties:
- Sample Demand: 13 gloves
- Batch size: 35,000 gloves
- Provenance: Not specified.
- Surface Powder Test:
- Sample size: 5 sub-samples (N=5) as per Table 1 (page 5), although another section mentions "3 sets of 2 gloves/batch". The results section states "Mean: 0.18mg/glove" for a test on 5pcs sub-samples (N=5).
- Provenance: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. This document describes non-clinical, laboratory-based physical and biological performance tests, not AI algorithm validation requiring expert human ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. This is not a human interpretation study. Acceptance is determined by meeting predefined numerical or qualitative criteria specified in the relevant ASTM/ISO standards.
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 document pertains to the regulatory clearance of a physical medical device (examination gloves), not an AI/ML diagnostic tool. There is no AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. No AI algorithm is involved.
7. The Type of Ground Truth Used
- Objective Measurement and Standard Compliance: The "ground truth" for these tests is based on objective laboratory measurements (e.g., water leakage, dimensions, tensile strength, residual powder) and predefined biological responses in accordance with internationally recognized standards (ASTM, ISO). For biocompatibility, it's about whether the material elicits a specific biological reaction (e.g., cytotoxicity, irritation, sensitization).
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no "training set" and therefore no ground truth establishment for it in this context.
§ 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.