(189 days)
IS A PATIENT EXAMINATION GLOVE WHICH IS A DISPOSABLE MEDICAL DEVICE INTENDED FOR MEDICAL PURPOSES THAT ARE WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT (50 MICROGRAMS OR LESS)
This document is a 510(k) premarket notification decision letter from the FDA to Oon Corporation Resources (M) Sdn. Bhd. regarding "Powder-Free (Chlorinated) Latex Examination Gloves with Protein Content Labeling Claim (50 Micrograms Or Less)."
This letter approves the device for marketing due to its substantial equivalence to legally marketed predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance data beyond the device's labeling claim of "50 Micrograms Or Less" for protein content.
Therefore, I cannot provide the requested information about acceptance criteria, study design, sample sizes, ground truth establishment, or expert information because:
- Acceptance Criteria and Reported Device Performance: These are not explicitly stated in the provided text. The letter only mentions a "Protein Content Labeling Claim (50 Micrograms Or Less)," which implies a performance characteristic but doesn't define formal acceptance criteria against a specific standard or test.
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, standalone, ground truth type, training set size, training ground truth): The document is a regulatory approval letter based on an application, not the study report itself. It does not describe the specific studies or data submitted by the manufacturer to support their claims. It only confirms the FDA's review and determination of substantial equivalence.
In summary, the provided text confirms the regulatory status of the device but lacks the detailed scientific study information requested.
§ 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.