(84 days)
A medical examination glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.
Polymer Coated Powder Free Latex Medical Examination Gloves with 50 Micrograms or Less of Total Water Extractable Protein per g.
This document is an FDA 510(k) clearance letter for "Polymer Coated Powder Free Latex Medical Examination Gloves with Protein Labeling Claim (50 Micrograms or Less)." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed acceptance criteria or study results in the format requested.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a device that is already on the market. The specific data that led to this determination, including detailed acceptance criteria and study designs, would be found in the 510(k) submission itself, not in this clearance letter.
To fully answer your request, one would need access to the actual 510(k) submission (K013554) filed by Maxter Glove Manufacturing Sdn. Bhd., which is not provided in the given text.
Therefore,Based on the provided document, I cannot generate the requested information about acceptance criteria and study details.
§ 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.