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510(k) Data Aggregation
(232 days)
Powder Free Nitrile Patient Examination Gloves, Blue Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Patient Examination Gloves. It details the device's characteristics and compares them to a predicate device to establish substantial equivalence.
Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The device's performance is compared against established standards, primarily ASTM D6319-10 (Reapproved 2015) for Nitrile Examination Gloves for Medical Application, along with other ISO and ASTM standards for biocompatibility and specific tests.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D 6319-06 (Reapproved 2015) | Dimension | ||
| - Length | ≥230mm min | 232 mm min for all sizes (Similar to predicate) | |
| - Width | Small: 70-90 mmMedium: 85-105mmLarge: 100-120mmX large: 110-130 mm | Small: 75-90 mmMedium: 88-102 mmLarge: 107-117mmX large: 114-128 mm (Similar to predicate) | |
| - Thickness | Fingertip: ≥0.05mm min.Palm: ≥0.05mm min. | Fingertip: ≥0.08mmPalm: ≥0.08mm (Similar to predicate) | |
| ASTM D 6319-06 (Reapproved 2015) | Physical Properties | ||
| - Tensile strength (Before & After aging) | ≥ 14MPa | 17-24 (Before Aging), 17-22 (After Aging) (Similar to predicate) | |
| - Before aging Elongation | ≥500% | 540-610 (Similar to predicate) | |
| - After aging Elongation | ≥400% | 460-570 (Similar to predicate) | |
| 21 CFR 800.20ASTM D 6319-06 (Reapproved 2015)ASTM D5151-19 | Freedom from pinholes | Water leakage test: Inspection Level I, AQL 2.5, and Accept/Reject criteria of 10/11. | 5 noncompliance is allowed (Similar to predicate) |
| ASTM D6319-10 (Reapproved 2015)ASTM D6124-06 (Reapproved 2017) | Powder Residual | <2mg/glove | Mean: 0.1mg/pcs (Similar to predicate) |
| Biocompatibility (ISO 10993-10:2010-08-01 - Primary Skin Irritation/Dermal Sensitization) | Biocompatibility | Non-irritant or non-sensitizer | Pass (Non-irritant, non-sensitizer) (Similar to predicate) |
| Biocompatibility (ISO 10993-5:2009 - Cytotoxicity) | Biocompatibility | Non-cytotoxicity to L-929 cells. | Cytotoxic (requires additional testing to assess systemic toxicity concern) (Different from predicate, further tested) |
| Biocompatibility (ISO 10993-11:2017 - Acute Systemic Toxicity) | Biocompatibility | Device extracts do not pose a systemic toxicity concern. | Pass (Device extracts do not pose a systemic toxicity concern) (Different from predicate) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state a specific numerical sample size for each test. However, it references industry standards like Inspection Level I, AQL 2.5, for Freedom from Pinholes which implies a statistically determined sample size for quality control testing of physical properties. For residual powder, it states "Checked on 5pcs sub-samples (N=5)".
- Data Provenance: The document does not explicitly state the country of origin of the data collection or if the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests performed (material properties, biocompatibility), these are typically controlled laboratory tests conducted during the device's development phase, likely in China where the manufacturer is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This 510(k) submission is for patient examination gloves, which are assessed based on established physical, chemical, and biological performance standards (e.g., ASTM, ISO). The "ground truth" is defined by meeting these predefined quantitative criteria. Therefore, there isn't a concept of "experts establishing ground truth" in the same way as with diagnostic AI. The performance is objectively measured against the specified thresholds in the standards by qualified testing laboratories.
4. Adjudication Method for the Test Set:
Not applicable in this context. The testing involves objective measurements against pre-defined numerical and qualitative standards, not human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a medical device (patient examination gloves) that does not involve diagnostic interpretation or human-in-the-loop performance improvement in the typical sense of an AI/imaging device. Clinical testing was explicitly stated as "not needed for this device."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a physical product, not a software algorithm. The "performance" is its intrinsic physical and biological characteristics.
7. The Type of Ground Truth Used:
The ground truth is based on established industry standards and regulatory requirements (e.g., ASTM D6319, ISO 10993, 21 CFR 800.20) for physical properties, chemical composition, and biocompatibility of patient examination gloves. These are objective, measurable performance criteria.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a "training set." The device's characteristics are determined by its manufacturing process and tested against objective standards, not by an algorithm learning from data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reason stated in point 8.
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