(154 days)
The powder free nitrile patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Powder Free Nitrile Patient 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 proposed device is Powder Free Nitrile Patient Examination Gloves, and includes variations of different size and color. The colors of proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
The provided text describes the acceptance criteria and the study results for the Powder Free Nitrile Patient Examination Gloves, Blue. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are established by various ASTM and ISO standards. The reported device performance generally indicates compliance with these standards.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| Physical Properties Before Aging (ASTM D6319) | |
| - Tensile Strength | 15 MPa |
| - Ultimate Elongation | 500 % min |
| Physical Properties After Aging (ASTM D6319) | |
| - Tensile Strength | 14 MPa |
| - Ultimate Elongation | 400 % min |
| Freedom from Holes (ASTM D5151) | Free from holes when tested in accordance with ASTM D5151 |
| Powder Content (ASTM D6124) | Max. 0.32 mg per glove |
| Biocompatibility (ISO 10993-10) | |
| - Irritation | Under the conditions of the study, not an irritant |
| - Sensitization | Under conditions of the study, not a sensitizer |
| Device Dimensions (ASTM D6319) | |
| - Length, mm (XS, S, M, L, XL) | min (specific values for XS-XL not provided for proposed, but for predicate) |
| - Width, mm (XS, S, M, L, XL) | 70, 80, 95, 110, 120 (± 10) |
| - Thickness, mm: Finger | 0.10 (± 0.03) |
| - Thickness, mm: Palm | 0.08 (± 0.03) |
| - Thickness, mm: Cuff | 0.06 (± 0.03) |
| Sampling Procedures for Inspection by Attributes (ISO 2859-1:1999) | Complies with standard |
2. Sample Size Used for the Test Set and the Data Provenance:
The document broadly states that "Bench tests were conducted to verify that the proposed device met all design specifications as compared to the predicate device."
- Sample Size: The exact sample size for each test is not specified in the provided document. The ISO 2859-1:1999 standard is cited for "Sampling Procedures for Inspection by Attributes - Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection," implying that sampling was done according to this standard, but the specific AQL levels or sample sizes used are not detailed.
- Data Provenance: The document implies the data is prospective as it describes tests conducted to verify the proposed device. The manufacturer is "HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP CO., LTD." in China, suggesting the tests were conducted in or overseen by this Chinese entity.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to this type of device (patient examination gloves). The "ground truth" for glove performance is established through objective physical, mechanical, and biological testing against recognized standards, not through expert human interpretation of results in the way an AI medical imaging device would require.
4. Adjudication Method for the Test Set:
This is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in expert-based assessments (e.g., medical image interpretation), which is not relevant here. The tests conducted are objective measurements against established 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 devices where human readers interpret medical images or data. The device in question is a physical medical glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable. "Standalone performance" refers to the performance of an algorithm or AI without human input in a diagnostic or interpretive context. The device is a physical glove, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used for proving the device meets acceptance criteria is based on objective measurement against established industry standards, specifically:
- ASTM Standards: ASTM D6319-10 (physical properties), ASTM D5151-06 (freedom from holes), ASTM D6124-06 (residual powder).
- ISO Standards: ISO 2859-1:1999 (sampling procedures), ISO 10993-10:2010 (biocompatibility: irritation and skin sensitization).
- Performance Metrics: Quantifiable measurements such as tensile strength (MPa), ultimate elongation (%), powder content (mg/glove), dimensions (mm), and qualitative assessments (e.g., "not an irritant," "free from holes").
8. The Sample Size for the Training Set:
This is not applicable as there is no "training set" in the context of physical medical devices like gloves. Training sets are used for machine learning models.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable as there is no training set.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.