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510(k) Data Aggregation
(74 days)
ZIBIO YINGJIE MEDICAL PRODUCTS CO., LTD
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.
Device Name: Zibo Yingjie Medical Products Co., Ltd. Synthetic Vinyl Patient Examination Gloves - Powder Free (K101565)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (Zibo Yingjie Medical Products Gloves) | Standard / Test Method |
|---|---|---|
| Physical and Dimensions Testing | Meets requirements | ASTM Standard D5250-06 |
| Water Fill Test (Pinhole integrity) | Meets requirements (AQL 2.5, Inspection Level I) | FDA 1000 ml. Water Fill Test |
| Primary Skin Irritation | No primary skin irritant reactions | Biocompatibility testing |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions | Biocompatibility testing |
| Powder-Free Claim (max 2 mg powder per glove) | Meets "powder-free" claims (contains no more than 2 mg powder per glove) | Testing conducted to ensure compliance |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual test (e.g., how many gloves were tested for pinholes, or how many subjects for biocompatibility).
The data provenance is from non-clinical tests conducted by Zibo Yingjie Medical Products Co., Ltd. in China (Zibo, Shandong). The tests are prospective, as they are performed to demonstrate compliance for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes the testing of a medical device (patient examination gloves) through physical and chemical property assessments based on established standards, rather than expert interpretation of medical images or data. Ground truth for these types of devices is based on objective measurements against defined specifications within recognized standards (e.g., ASTM, FDA regulations).
4. Adjudication Method for the Test Set
This information is not applicable as adjudication methods (like 2+1 or 3+1) are typically used in studies involving human interpretation or subjective assessments, such as evaluating medical images. The tests for these gloves are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often to compare AI-assisted performance with unassisted performance. This device is a disposable medical glove, and its performance is evaluated through physical and chemical testing against established standards, not through human reader interpretation of outputs.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical glove, not an algorithm or software. Therefore, there is no "standalone" algorithm performance to evaluate. The device itself is evaluated in a standalone manner against physical and chemical specifications.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Established standards and specifications: Specifically, ASTM Standard D5250-06 for physical and dimensional properties, and FDA requirements for pinhole integrity.
- Biocompatibility testing results: Demonstrating no primary skin irritation or sensitization reactions.
- Quantitative measurements: For powder content (no more than 2 mg per glove).
These are objective, quantifiable criteria defined by regulatory bodies and consensus standards, not subjective expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic device study.
8. The Sample Size for the Training Set
This information is not applicable. The device is a manufactured product (gloves) and does not involve a "training set" in the context of machine learning algorithms or statistical models that require data to be trained. The manufacturing process is subject to quality control and adherence to specifications, but not a "training set" like that seen in AI/ML development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. There is no training set for this device.
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