(109 days)
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient.
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim of 50 Micrograms per dm2 or Less Protein are single use. Non sterile, natural rubber latex powder-free examination gloves. They are available in one color (blue) and come in five sizes: Small, Medium, Large, Extra Large, and Extra Extra Large. The subject gloves meet all the requirements of ASTM D3578-19 Standard Specification for Rubber Examination Gloves.
This document is a 510(k) clearance letter for medical examination gloves. It is not a document describing a study for a medical device that uses AI or requires expert ground truth. Therefore, I cannot provide the requested information.
The prompt specifically asks for details related to:
- A table of acceptance criteria and device performance for an AI/ML device.
- Sample sizes for test and training sets (relevant to AI/ML).
- Number and qualifications of experts for ground truth (relevant to AI/ML).
- Adjudication methods (relevant to AI/ML).
- MRMC studies (relevant to AI/ML).
- Standalone algorithm performance (relevant to AI/ML).
- Type of ground truth used (relevant to AI/ML).
- How ground truth was established for training (relevant to AI/ML).
The provided text discusses the non-clinical performance testing of rubber examination gloves. The "acceptance criteria" and "results" tables in the document pertain to physical and chemical properties of gloves (e.g., length, width, thickness, tensile strength, protein content, biocompatibility) tested against established ASTM and ISO standards for medical gloves.
There is no mention of an algorithm, AI, machine learning, human-in-the-loop performance, or expert review for diagnostic purposes. The "ground truth" in this context refers to the measured physical and chemical properties of the gloves conforming to established industry standards, not expert interpretations of medical images or data.
§ 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.