(46 days)
The Nitrile Glove Powder Free White is a disposable device intended purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is white. The proposed device is non-sterile.
The provided document is a 510(k) summary for the "Nitrile Glove Powder Free White." This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a predicate device already on the market. It primarily focuses on comparing the new device's characteristics and performance to the predicate device and relevant standards, rather than describing a traditional clinical study with human subjects, AI involvement, or ground truth establishment as might be found for more complex diagnostic devices.
Therefore, many of the requested categories are not directly applicable or are not detailed in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are established by various ASTM and ISO standards, and the reported device performance indicates compliance with these standards.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Nitrile Glove Powder Free White) |
|---|---|
| Physical Properties (Before Aging): | |
| Tensile Strength (ASTM D6319) | 14MPa, min |
| Ultimate Elongation (ASTM D6319) | 500% min |
| Physical Properties (After Aging): | |
| Tensile Strength (ASTM D6319) | 14MPa, min |
| Ultimate Elongation (ASTM D6319) | 400% min |
| Compliance with ASTM D6319 | Complies |
| Freedom from Holes (ASTM D5151) | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 |
| Powder Content (ASTM D6124) | 0.47 mg per glove (meets requirements) |
| Biocompatibility: | |
| Irritation (ISO 10993-10) | Under the conditions of the study, not an irritant |
| Sensitization (ISO 10993-10) | Under conditions of the study, not a sensitizer. Complies with ISO10993-10 |
| Cytotoxicity (ISO 10993-5) | Under conditions of the study, device extract is not cytotoxic |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (e.g., number of gloves tested for tensile strength or holes). It refers to compliance with standards like ASTM D5151 and D6319, which would typically define such sample sizes. The data provenance is implied to be from laboratory testing performed by "Haining Medical Products Co., Ltd." or their designated testing facilities in China (as per the submitter's address). The tests are non-clinical tests, not studies with human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device and submission. The "ground truth" for medical gloves is established by objective physical and chemical testing against recognized international and national standards (e.g., ASTM, ISO) for properties like tensile strength, elongation, freedom from holes, powder content, and biocompatibility. There are no human "experts" establishing a "ground truth" in the clinical sense for this product's performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where subjective interpretation of images or other data by multiple readers is involved. For medical glove testing, objective measurements against pre-defined thresholds from standards are used.
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
This is not applicable. This document concerns a physical medical device (nitrile gloves), not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This document concerns a physical medical device (nitrile gloves), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by objective measurements and laboratory tests against the specific requirements and methodologies outlined in the referenced standards (ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5). For example, "freedom from holes" is determined by a specific test method in ASTM D5151, not by expert consensus or pathology. Biocompatibility is assessed through standardized in-vitro and in-vivo tests as per ISO 10993.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This is not applicable as there is no training set mentioned or relevant to this device's submission.
§ 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.