(64 days)
A powder-free 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.
Midas Touch™ - Nitrile Examination Gloves Powder free, Pink
The provided text is a 510(k) premarket notification letter from the FDA for medical gloves, specifically "Midas Touch 101 - Nitrile Examination Gloves-Powder Free, Pink."
This document does not contain information about acceptance criteria and a study proving a device's performance in the sense of an AI/ML or diagnostic device. Instead, it concerns the FDA's determination of substantial equivalence for a patient examination glove to predicate devices.
Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets those criteria, as the document does not pertain to such a study or device.
The document primarily focuses on:
- Regulatory Clearance: K122465, indicating the FDA has reviewed the submission and determined substantial equivalence.
- Device Type: Nitrile Examination Gloves, Powder Free, Pink.
- Intended Use: "A powder-free 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."
- Regulatory Classification: Class I, Product Code LZA (Patient Examination Glove).
- Manufacturing Information: Industrial Clothings, Limited, Prime Polymers Division, from Sri Lanka.
For a medical glove, acceptance criteria would typically relate to physical properties (e.g., tensile strength, elongation), barrier integrity (e.g., freedom from pinholes, viral penetration), sterility (if applicable), and biocompatibility. The "study" proving these would be laboratory testing against recognized standards (e.g., ASTM standards for medical gloves). This specific FDA letter, however, only states that substantial equivalence has been determined, implying that such testing was submitted and found acceptable by the FDA, but it does not detail the tests, methodology, or results within the letter itself.
§ 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.