(19 days)
A patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient
Powder-Free Nitrile Examination Glove, BLUE
This FDA 510(k) clearance letter and associated documents describe the approval of "Powder-Free Nitrile Examination Glove, Blue." This is a medical device approval, not an AI/ML device approval, and therefore the requested information regarding AI/ML device performance, study design, and ground truth establishment is not applicable.
The document indicates that the device is a "patient examination glove that is worn by the healthcare or similar personnel to prevent contamination between the healthcare personnel and the patient."
Key points from the document regarding the device's regulatory pathway:
- Regulation Number: 880.6250
- Regulation Name: Patient Examination Gloves
- Regulatory Class: I (indicating lower risk, typically cleared via 510(k) processes without extensive clinical trials)
- Product Code: LZA
- Substantial Equivalence: The device was found substantially equivalent to legally marketed predicate devices, which is the primary basis for 510(k) clearance. This means it performs similarly to other gloves already on the market and has the same intended use.
Since this is a Class I device and the clearance is based on substantial equivalence to existing devices, the types of detailed performance studies and ground truth establishment typically required for AI/ML devices or higher-risk medical devices are not present or required in this submission. The acceptance criteria for such a device would generally relate to manufacturing standards, biocompatibility, and physical properties (e.g., tensile strength, barrier integrity) that are assessed through laboratory testing rather than human reader studies or large-scale clinical trials.
Therefore, the requested information cannot be provided as it pertains to a different type of medical device and regulatory pathway.
§ 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.