(18 days)
The Single-use medical latex 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 Single-use medical latex examination qloves 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 made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is provided non-sterile, in sizes XS, S, M, L and XL, natural white color, powder free, and the shelf life is 3 years.
The provided text describes the 510(k) premarket notification for a medical device: "Single-use medical latex examination gloves (LG100)". This document is not for an AI/ML-based medical device. Therefore, the questions related to AI/ML device testing (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (K214017) through non-clinical performance testing against established ASTM and ISO standards for examination gloves.
Here's the relevant information based on the provided text, primarily focusing on the acceptance criteria and performance of the glove:
Acceptance Criteria and Device Performance for Single-use Medical Latex Examination Gloves (LG100)
This device is not an AI/ML system, but rather a physical medical device (examination gloves). Therefore, the acceptance criteria and study data relate to physical, chemical, and biological properties of the gloves, not algorithmic performance.
1. A table of acceptance criteria and the reported device performance:
| Test Methodology | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| ASTM D3578-19 | Physical Dimension | The actual measured dimension of the gloves shall meet the stated tolerance specified in Table 2 of the ASTM D3578-19: |
- Width ± 10mm
- Length: XS-S 220 min, M-XL 230 min
- Thickness (finger and Palm): 0.08 min | Meet the requirement |
| ASTM D3578-19 | Determination of Physical Properties | Before and after accelerated aging, the gloves shall conform to the physical requirements in Table 3 of ASTM D3578-19.
Before Aging: - Tensile Strength: 18 MPa min
- Stress Elongation: 5.5 MPa max
- Ultimate Elongation: 650% min
After Accelerated Aging: - Tensile Strength: 14 MPa min
- Ultimate Elongation: 500% min | Meet the requirement |
| ASTM D5151-19 | Water Leak Test for Detection of Holes | The gloves shall be free from holes when tested in accordance with the method given in ASTM D5151. AQL=2.5 | Meet the requirement |
| ASTM D6124-06 (Reapp. 2017) | Residual Powder Content Test | The powder residue content shall be not more than 2mg per glove. | Meet the requirement |
| ASTM D3578-19 | Protein Content | ≤ 200 ug/dm² | Meet the requirement |
| ISO 10993-5:2009 | In vitro Cytotoxicity | Non-cytotoxicity | Failed (Potential toxicity Grade 3 or 4) Self-contradictory with the conclusion of "as safe" |
| ISO 10993-10:2010 | Skin Sensitization | Non-sensitizing | Meet the requirement |
| ISO 10993-10:2010 | Skin Irritation | Non-irritating | Meet the requirement |
| ISO 10993-11:2017 | Systemic Toxicity | Non-systemic toxicity | Meet the requirement |
Note: The results for "In vitro Cytotoxicity" indicate "Failed (Potential toxicity Grade 3 or 4)", which seems to contradict the overall conclusion of the device being "as safe, as effective, and performs as well as or better than the legally marketed predicate device". This would warrant further investigation if this were a complete regulatory review. However, the provided text is the basis for this answer.
The following questions are not applicable to this 510(k) submission as it pertains to a physical medical device (examination gloves) and not an AI/ML-based device:
- Sample sizes used for the test set and the data provenance: Not applicable. Tests are conducted according to published standards (e.g., AQL for water leak tests), not on subjective data sets. The testing is non-clinical, done by the manufacturer (Fitone Latex Products Co., Ltd. Guangdong, China).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is established by objective physical and chemical testing standards, not expert consensus on medical images or diagnoses.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on established international standards (ASTM, ISO) for physical, chemical, and biological properties of medical gloves (e.g., tensile strength, freedom from holes, protein content, cytotoxicity tests).
- 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.
§ 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.