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Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple 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.

Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves are manufactured to meet the all current specifications listed under the ASTM Specification D6319 - 19, Standard Specification for Nitrile Examination Gloves for Medical Application. Powder Free Green Nitrile Examination Gloves, Powder Free Pink Nitrile Examination Gloves and Powder Free Purple Nitrile Examination Gloves are mainly composed of nitrile latex. It is mainly suitable for hand protection during medical examination. These gloves are powder free. The difference between the devices is the color of powder free green nitrile examination gloves is green, the color of powder free pink nitrile examination gloves is pink, the color of powder free purple nitrile examination gloves is purple. The proposed device(s) are sold non-sterile and are intended to be single-use, disposable devices.

The medical device in question is the "Powder Free Green/Pink/Purple Nitrile Examination Gloves." The documentation provided describes the acceptance criteria and the non-clinical studies performed to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

• Length (mm): XS/S/M/L/XL: ≥230
• Width(mm): XS: 70±10mm; S: 85±10mm; M: 95±10mm; L: 110±10 mm; XL: 120±10 mm
• Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Physical Dimensions:
• Length(mm): XS/S/M/L/XL: 236~239 (Pass)
• Width(mm): XS 70; S 8586; M 9596; L 110~112; XL 120 (Pass)
• Finger: 0.23~0.47 (Pass)
• Palm: 0.26~0.46 (Pass) |
  | ASTM D5151-19 | Watertightness Test for Detection of Holes:
• Be free from holes when tested in accordance with ASTM D5151 | Pass |
  | ASTM D412 | Physical Properties:
• Before Aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 500% min
• After Aging: Tensile Strength: 14MPa, min; Ultimate Elongation: 400% min | Physical Properties:
• Before Aging: Tensile Strength: 20.1628.78MPa (Pass); Ultimate Elongation: 522558% (Pass)
• After Aging: Tensile Strength: 18.2520.39MPa (Pass); Ultimate Elongation: 525555% (Pass) |
  | ASTM D6124 | Powder Content:
• Meet the requirements of Less than 2mg per glove | ≤0.46mg (Pass) |
  | ISO 10993-10 | Irritation:
• Non-irritating | Under the conditions of the study, not an irritant. |
  | ISO 10993-11 | Acute systemic toxicity:
• Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo. |
  | ISO 10993-23 | Sensitization:
• Non-sensitizing | Under the conditions of the study, not a sensitizer. |

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes for each specific test within the non-clinical studies. However, the tests were conducted according to recognized international and national standards (ASTM and ISO). The provenance of the data is not specified beyond indicating that the studies were performed as part of the regulatory submission process for the manufacturer, Hebei Titans Hongsen Medical Technology Co., Ltd. in China. These studies are typically prospective tests conducted on representative samples of the manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. The ground truth for these types of devices (examination gloves) is established by performance against pre-defined, objective physical, chemical, and biological criteria outlined in the referenced standards (ASTM, ISO). Expert consensus is not typically used to establish ground truth for these quantitative, standardized tests.

4. Adjudication Method for the Test Set:

Not applicable. As the tests are based on objective, standardized measurements against specified criteria, an adjudication method for test results is not typically required. The results are quantitative and compared directly to the predetermined acceptance limits.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not applicable for examination gloves, which are physical barriers designed for medical purposes. MRMC studies are typically used for diagnostic devices that involve human interpretation or decision-making aided by AI.

6. Standalone Performance Study:

Yes, a standalone study was performed. The non-clinical tests described (physical dimensions, watertightness, physical properties, powder content, biocompatibility) assess the performance of the device itself (the gloves) against established standards. This represents the standalone performance of the algorithm (in this context, the gloves as a product) without human-in-the-loop performance measurement.

7. Type of Ground Truth Used:

The ground truth used for the non-clinical tests is based on pre-established, objective criteria and limits defined within recognized international and national standards (e.g., ASTM D6319-19, ASTM D5151-19, ISO 10993 series). These standards outline the acceptable ranges for physical properties and the expected biological responses.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The "device" is a physical product (gloves) whose performance is evaluated through non-clinical testing against established standards.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a physical device like examination gloves.

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