(156 days)
The Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove - Lemon Green (Lavender Scent) 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.
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I am sorry, but based on the provided document, there is no scientific study or data available to describe the acceptance criteria, device performance, and other related details you requested.
The document is a letter from the FDA to Hartalega Sdn. Bhd. regarding their 510(k) premarket notification for "Latex Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information for marketing the device.
The document does not contain:
- A table of acceptance criteria or reported device performance.
- Information about sample sizes for test sets or data provenance.
- Details on the number or qualifications of experts used for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- The type of ground truth used (pathology, outcomes data, etc.).
- Sample size for training sets.
- How ground truth for training sets was established.
This document is a regulatory clearance letter, not a scientific study report.
§ 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.