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510(k) Data Aggregation
(93 days)
The Nitrile Patient Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger 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.
The provided text describes the acceptance criteria and performance of a Nitrile Patient Examination Glove, not an AI-powered medical device. Therefore, the questions related to AI device performance metrics, such as ground truth, expert consensus, MRMC studies, and training/test sets, are not applicable in this context.
This document is a 510(k) Premarket Notification for a Class I medical device (nitrile examination glove), which establishes substantial equivalence to a predicate device based on physical and performance characteristics, and biocompatibility.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on established ASTM and ISO standards for medical gloves. The reported device performance is compared against these standards and the predicate device.
| Test / Characteristic | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Irritation (ISO 10993-10:2010) | Primary Irritation Index: 0-0.4 (Negligible) | Primary irritation index is 0. Response categorized as negligible. All animals survived with no abnormal signs. |
| Sensitization (ISO 10993-10:2010) | Grades less than 1 (no sensitization) | All grades are 0. Not a sensitizer under study conditions. |
| Cytotoxicity (ISO 10993-5:2009) | Viability (viab.%) of 100% extract ≥ 70% of blank (no cytotoxic potential) | Viab.% of 100% test article extract is 70.9%. No potential toxicity to L-929 in MTT method. |
| Physical Properties | ||
| Residual Powder (ASTM D6124-06) | <0.25 mg/glove (Table 4) or 2.0 mg (Table 5) | <0.25 mg/glove |
| Freedom from Holes (ASTM D5151-19) | AQL=2.5, criterion ≤ 7 gloves for water leakage (Sample size: 125 gloves) | No glove water leakage found. |
| Dimensions (ASTM D6319-19) | Min Length: S (220mm), M, L, XL (230mm) Width: S (80±10mm), M (95±10mm), L (110±10mm), XL (120±10mm) Min Thickness (Finger/Palm): 0.05mm | Length (mm): S: 297-302, M: 296-302, L: 296-302, XL: 297-302 (All meet min length) Width (mm): S: 84-87, M: 94-97, L: 104-108, XL: 113-117 (All meet ±10mm tolerance) Thickness (mm): Finger: 0.152-0.184, Palm: 0.112-0.131 (All meet min 0.05mm) |
| Physical Properties | ||
| Before Aging: Tensile Strength | ≥ 14MPa | 14.2-29.0 MPa |
| Before Aging: Ultimate Elongation | ≥ 500% | 537.700% - 552.733% |
| After Accelerated Aging: Tensile Strength | ≥ 14MPa | 14.1-26.8 MPa |
| After Accelerated Aging: Ultimate Elongation | ≥ 400% | 421.422% - 552.633% |
2. Sample size used for the test set and the data provenance
- Freedom from Holes (ASTM D5151-19): 125 gloves were tested.
- Other tests (Biocompatibility, Dimensions, Physical Properties, Powder Content): Specific sample sizes for each test are not explicitly stated in the provided text, but testing was conducted to meet the requirements of the referenced ASTM and ISO standards, which define appropriate sample sizes and methodologies.
- Data Provenance: Not specified in terms of country of origin for the test data. The manufacturer is Jiangxi Zhonghong Pulin Medical Products Co.,Ltd. in China. The data would be prospective, as it's generated specifically for this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device (glove), not an AI diagnostic tool that requires expert interpretation of images or other data for ground truth establishment. The "ground truth" here is the physical and chemical properties of the glove measured against established engineering and biological standards.
4. Adjudication method for the test set
Not applicable for a medical glove. Testing relies on standardized methods and laboratory measurements, not human adjudication of results in the way AI model outputs are typically adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done
Not applicable. MRMC studies are used for diagnostic imaging devices/algorithms to assess how human reader performance is affected by AI assistance. This device is a physical examination glove.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm to assess.
7. The type of ground truth used
The "ground truth" for this device is based on:
- Standardized Test Methods: Adherence to established international and national standards (e.g., ISO 10993 for biocompatibility, ASTM D6319 for physical properties of gloves, ASTM D5151 for freedom from holes).
- Reference Materials/Controls: For biocompatibility tests, positive and negative controls would be used as part of the standard methodology (ISO 10993).
- Objective Measurements: Laboratory measurements of physical dimensions, tensile strength, elongation, powder content, and visual inspection for holes.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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