(78 days)
A medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient. It is a single use disposable glove.
Nitrile Powder Free Patient Examination Gloves, Now-Stern e Device Name
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets those criteria.
The document is a letter from the FDA to Seltom Pacific SDN. BHD. regarding the clearance of Nitrile Examination Gloves Powder Free (white) under K991776. It states that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
However, it does not contain any details about:
- Specific acceptance criteria for the gloves (e.g., tensile strength, barrier integrity, tear resistance).
- A study conducted to prove the device meets any such criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth was established.
The letter primarily focuses on the regulatory aspects of 510(k) clearance and general controls. The "Indications for Use" section simply describes the purpose of the medical glove.
§ 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.