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510(k) Data Aggregation
(91 days)
The nitrile examination glove is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
This document pertains to the 510(k) premarket notification for "Nitrile Examination Gloves" by Wuhan Huirui Technology Co., Ltd. The submission argues for substantial equivalence to a predicate device (K203593) based on non-clinical testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S:≥220; M/L/XL:≥230; Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: > 230 (Pass); Width: S: 83-87 (Pass), M: 93-97 (Pass), L: 102-107 (Pass), XL: 113-117 (Pass); Thickness: Finger: 0.08-0.09 (Pass), Palm: 0.06 (Pass) | Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 (Pass) | Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.09-0.11mg (Pass) | Pass |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 14.24-22.44MPa (Pass); Ultimate Elongation: 507-752% (Pass) | Pass |
| ASTM D412 | Physical properties (After Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 14.23-20.25MPa (Pass); Ultimate Elongation: 505-763% (Pass) | Pass |
| ISO 10993-11 | Systemic Toxicity | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo (Pass) | Pass |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant (Pass) | Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer (Pass) | Pass |
2. Sample size used for the test set and the data provenance
The document indicates "Non-clinical tests were conducted". For specific tests, limited sample size information is provided:
- Watertightness Test (ASTM D5151): The result is stated as "0/125/Pass". This implies a sample size of 125 gloves were tested for holes, and none were found.
- Other tests (Physical Dimensions, Powder Content, Physical Properties, Biocompatibility): The exact sample sizes for these tests are not explicitly stated within the provided text.
Data Provenance: The tests were conducted to verify that the proposed device met all design specifications. The document does not specify the country of origin of the data directly for the testing, but the submitting company is Wuhan Huirui Technology Co., Ltd. in China, suggesting the testing likely occurred there. The testing is assumed to be prospective as it's part of a premarket notification for a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a physical product (nitrile gloves) and the "ground truth" is established through standardized physical, chemical, and biological testing as per ASTM and ISO standards. Therefore, clinical expert consensus for "ground truth" as might be seen for an AI diagnostic device is not applicable here. The testing would have been performed by qualified laboratory technicians and scientists following the specified test protocols. The document does not detail the number or specific qualifications of these individuals.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against established standards, not subjective interpretations requiring adjudication.
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 physical product (nitrile examination gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical product (nitrile examination gloves), not an algorithm.
7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements (ASTM and ISO standards) for physical, chemical, and biological properties of examination gloves. These are objective, measurable criteria.
8. The sample size for the training set
Not applicable. This is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical product, there is no ground truth to be established for it in this context.
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