(27 days)
Laglove™ Brand Polymer Coated Latex examination glove (powder free) is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between patient and examiner.
Laglove™ Brand Polymer Coated Latex Examination Glove (Powder-Free) Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram
I apologize, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for "Laglove™ Brand Polymer Coated Latex Examination Glove (Powder-Free)". It confirms that the device is substantially equivalent to previously marketed devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed study parameters you've requested (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.).
The letter primarily focuses on:
- Regulatory status: Classification as Class I and substantial equivalence to predicate devices.
- General controls: Requirements for annual registration, listing of devices, GMP, labeling, and prohibitions against misbranding and adulteration.
- Marketing permission: Granting permission to market the device.
To answer your request, I would need a document that describes the performance study conducted for these gloves, including the data you've asked for. This FDA letter simply states that the device is "substantially equivalent" based on information they reviewed, but it does not detail what that information was in terms of a performance study and its methodology.
§ 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.