(68 days)
The Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential is a medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential meet ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document pertains to the 510(k) submission for Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential (K241528).
1. A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Dimensions - Thickness | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application | |
| ISO 2859-1/S2/AQL 4.0 | ||
| Length - Size XS, S, M, L, XL – Min. 230 mm | ||
| Width - XS - 70±10mm, S – 80±10mm, M – 95±10mm, L – 110±10mm, XL – 120±10mm | ||
| Thickness at Finger – min. 0.05mm | ||
| Thickness at Palm – min. 0.05mm | Pass | |
| Physical Properties | ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application & ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension | |
| Before aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500% | ||
| After aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400% | Pass | |
| Powder Residue | ASTM D6124-06(2022) Standard Test Method for Residual Powder on Medical Gloves | |
| ≤ 2 mg/glove | Pass | |
| Freedom from Holes | ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves | |
| AQL 1.5 | Pass | |
| Irritation | ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation | |
| Under the conditions of the study, the device is not an irritant. | Under the conditions of the study, the device was not an irritant. | |
| Sensitization | ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization | |
| Under the conditions of the study, the device is not a sensitizer. | Under the conditions of the study, the device was not a sensitizer. | |
| Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices-Part 5 Tests for in vitro cytotoxicity | |
| Under the conditions of the study, the subject device extract does not exhibit cytotoxicity reactivity. | Under the conditions of the study, the subject device extract exhibits cytotoxicity from 100.0% extract concentrations to 50.0% extract concentrations and no cytotoxicity reactivity from 25.0% extract concentrations to 3.125% extract concentrations. (Note: This is a deviation from the acceptance criteria, as the device exhibited cytotoxicity at higher concentrations). | |
| Acute systemic toxicity | ISO 10993-11 Biological evaluation on medical device Part 11 - Test for systemic toxicity | |
| Under the conditions of this study, the test article does not induce acute systemic toxicity. | Under the conditions of this study, the test article did not induce acute systemic toxicity. | |
| Low Dermatitis Potential (Modified Draize) | Modified Draize ASTM 6355-07 Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves. | |
| No clinical evidence that the glove may induce Type IV allergy in the unsensitized general user population. | There was no clinical evidence that the glove may induce Type IV allergy in the unsensitized general user population. |
2. Sample size used for the test set and the data provenance:
- Physical Dimensions, Physical Properties, Powder Residue, Freedom from Holes: The specific sample sizes are not explicitly stated within the provided text, but the tests were conducted according to ASTM and ISO standards (e.g., ISO 2859-1/S2/AQL 4.0 for dimensions, AQL 1.5 for freedom from holes), which prescribe sampling plans. The data provenance is from non-clinical tests conducted by the manufacturer, Comfort Rubber Gloves Industries Sdn. Bhd. No country of origin for the specific testing labs is provided, nor is it specified if the data is retrospective or prospective, though it's likely prospective for the submission.
- Irritation, Sensitization, Cytotoxicity, Acute systemic toxicity: The specific sample sizes for these biocompatibility tests are not explicitly stated in the document. These tests are likely performed ex vivo or in vivo with animal models (e.g., mice for acute systemic toxicity) or in vitro (e.g., for cytotoxicity). The data provenance is from non-clinical tests conducted by the manufacturer.
- Low Dermatitis Potential (Modified Draize): The specific sample size for the human repeat insult patch test (HRIPT) is not explicitly stated. The Modified Draize test (ASTM 6355-07) is a clinical test involving human subjects, therefore, the data provenance is clinical, likely from a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The tests performed are primarily laboratory-based or standardized clinical tests with defined acceptance criteria, rather than requiring expert interpretation for ground truth establishment in the traditional sense of medical image analysis or complex diagnostic tasks. The "ground truth" for these tests is the quantitative or qualitative outcome against a standard.
4. Adjudication method for the test set:
Not applicable. The tests performed are objective, standardized tests with predefined acceptance criteria. There is no mention or implication of a need for adjudication by multiple human experts for the results of these physical, chemical, or biological tests.
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 device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical glove, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for most of these tests is based on objective measurements and established standards:
- Physical Properties (Dimensions, Tensile Strength, Elongation, Powder Residue, Freedom from Holes): Ground truth is based on quantitative measurements against the physical requirements specified in ASTM D6319-19, ASTM D412-16(2021), ASTM D6124-06(2022), and ASTM D5151-19.
- Biocompatibility (Irritation, Sensitization, Acute Systemic Toxicity): Ground truth is based on observations and measurements from standardized biological evaluations (ISO 10993 series) against set criteria for biological responses.
- Cytotoxicity: Ground truth is based on observable cellular responses in in vitro tests (ISO 10993-5).
- Low Dermatitis Potential (Modified Draize): Ground truth is based on the absence of clinical evidence of Type IV allergy in human subjects, as observed and reported in the HRIPT study, following ASTM 6355-07. This involves clinical observation in human subjects.
8. The sample size for the training set:
Not applicable. This is a physical medical device (gloves) and not an AI/ML-based algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. As this device is a medical glove, it does not involve a training set or associated ground truth establishment for an AI/ML model.
§ 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.