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510(k) Data Aggregation
(82 days)
The Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
This document describes the premarket notification (510(k)) for Nitrile Examination Gloves submitted by Zhenjiang Huayang Latex Products Co., Ltd. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) | Remark |
|---|---|---|---|
| Physical Properties | |||
| Before Aging | |||
| Tensile Strength | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 500% min | 500% min | Same |
| After Aging | |||
| Tensile Strength | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation | 400%min | 400%min | Same |
| Overall Compliance | Comply with ASTM D6319 | Comply with ASTM D6319 | Same |
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same |
| Powder Content | Meet the requirements of ASTM D6124 | 0.02 mg per glove | Same |
| Biocompatibility | |||
| Irritation | Not an irritant | (Implicitly meets standard ISO 10993-10:2010) | Same |
| Sensitization | Not a sensitizer | (Implicitly meets standard ISO 10993-10:2010) | Same |
| Cytotoxicity | Device extract is not cytotoxic | (Implicitly meets standard ISO 10993-5:2009) | Same |
| Dimensions | |||
| Length (mm) | 230 min (for S, M, L, XL sizes) | 230 min (for S, M, L sizes) | Similar (although subject device only tested S, M, L) |
| Width (mm) | 75, 85, 95, 105, 115 ±5 (for XS, S, M, L, XL) | 80, 95, 110 ±10 (for S, M, L) | Similar (Physical dimensions are different but meet ASTM D6319-19 requirements) |
| Finger Thickness (mm) | 0.05 min | 0.05 min | Similar |
| Palm Thickness (mm) | 0.05 min | 0.05 min | Similar |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the non-clinical tests (physical properties, freedom from holes, powder content, and biocompatibility). The provenance of the data is retrospective, as it refers to testing conducted on the subject device to demonstrate substantial equivalence to a legally marketed predicate device. The country of origin of the device manufacturer is China (Zhenjiang Huayang Latex Products Co., Ltd. in Jiangsu Province, P.R.China).
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 "ground truth" here is established by standardized test methods (e.g., ASTM, ISO) performed in a laboratory setting, rather than through expert consensus in a medical imaging or diagnostic context.
4. Adjudication method for the test set
This information is not applicable to this type of device comparison. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution. For a medical glove, performance is evaluated against defined test 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
This is not applicable. An MRMC study is relevant for AI-assisted diagnostic tools. This device is a nitrile examination glove, which does not involve human readers or AI assistance in a diagnostic capacity.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This refers to the performance of an algorithm without human input, which is not relevant for a medical glove.
7. The type of ground truth used
The ground truth used for this device is based on standardized test methods and specifications (e.g., ASTM D6319, ASTM D5151, ASTM D6124, ISO 10993-10, ISO 10993-5) and comparison to a legally marketed predicate device.
8. The sample size for the training set
This is not applicable. This device is not an AI/ML algorithm that requires a "training set." Its performance is evaluated through physical and chemical testing.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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