(221 days)
The Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) is a disposable device intended for medical purpose that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size and color. The colors of the proposed device are Blue, Black, and Indigo.
The provided document is a 510(k) Premarket Notification for Powder Free Nitrile Examination Gloves. This type of medical device is a Class I device and does not fall under the category of AI/ML-powered medical devices that would typically involve the comprehensive testing and data requirements outlined in the prompt's request.
Therefore, the document does not contain the information requested regarding acceptance criteria and study proving device meets acceptance criteria for an AI/ML-powered device. Specifically:
- No AI/ML Component: The device is a physical examination glove, not an AI/ML system.
- No Comparative Effectiveness Study: There is no multi-reader multi-case (MRMC) comparative effectiveness study, as it's not a diagnostic or AI-assisted interpretation device.
- No Standalone Algorithm Performance: The concept of standalone algorithm performance does not apply to a physical glove.
- No Ground Truth Establishment for AI Models: The document describes physical and biological testing for a glove (e.g., tensile strength, pinholes, biocompatibility), not the establishment of ground truth for training or testing an AI model.
- No Training or Test Sets for AI: The terms "training set" and "test set" in the context of AI/ML are not applicable to the non-clinical testing performed for these gloves.
- No Expert Adjudication for AI: The biological and physical tests performed for gloves do not involve expert radiologists or other medical experts establishing ground truth for AI performance.
The document focuses on demonstrating substantial equivalence to a predicate device (K150340) through non-clinical performance testing for physical properties and biocompatibility.
However, to answer the prompt based on the information that is present in the document for this specific device (Powder Free Nitrile Examination Gloves), I will present the acceptance criteria for the physical and biological properties of the gloves and their performance results.
Acceptance Criteria and Device Performance (for Powder Free Nitrile Examination Gloves)
The study proves the device meets the acceptance criteria through non-clinical performance testing, demonstrating substantial equivalence to a legally marketed predicate device (K150340).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM standards (D6319, D6124-06, D5151 06) and ISO 10993 series for biological evaluation. The results consistently "Meet requirement" or show compliance with the specified criteria.
| Test Methodology / Standard | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties (from Tables 2/8/14) | |||
| Tensile Strength (Unaged) | To assess the glove's strength before aging. | ≥ 14 MPa | ≥ 14 MPa (Meets requirement of ASTM D6319) |
| Elongation at Break (Unaged) | To assess the glove's elasticity before aging. | ≥ 500% | ≥ 500% (Meets requirement of ASTM D6319) |
| Tensile Strength (Aged) | To assess the glove's strength after accelerated aging. | ≥ 14 MPa | ≥ 14 MPa (Meets requirement of ASTM D6319) |
| Elongation at Break (Aged) | To assess the glove's elasticity after accelerated aging. | ≥ 400% | ≥ 400% (Meets requirement of ASTM D6319) |
| Freedom of Holes (ASTM D5151 06) | To detect holes in medical gloves. | Samples: 500 gloves; AQL: 2.5 (ISO 2859); Criterion: ≤ 21 gloves for water leakage | Requirement met. |
| Residual Powder (ASTM D6124-06) | To determine the amount of residual powder on medical gloves. | Powder residue limit of 2.0 mg/glove | Avg. S: 0.30 mg/glove, M: 0.31 mg/glove, L: 0.45 mg/glove (Requirement met). |
| Biocompatibility (from Tables 6/12/18) | |||
| ISO 10993-10:2010 (Skin Sensitization) | Assesses possible contact hazards from chemicals, specifically skin sensitization. | Grades Less than 1.0 ( |
§ 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.