(41 days)
A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Pre-powdered Nitrile Examination Gloves
The document is a 510(k) clearance letter from the FDA for "Pre-Powdered Nitrile Examination Gloves" manufactured by P.T. Latexindo Tobaperkasa. It states that the device is substantially equivalent to devices marketed before May 28, 1976, and therefore can be marketed.
This document is a regulatory clearance letter, not a study report or technical specification detailing performance criteria and a study proving those criteria were met. Therefore, none of the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth, expert involvement, adjudication, or MRMC studies can be extracted from this document.
The letter confirms the device's classification and substantial equivalence but does not provide the technical data or study results that would typically be included in a submission demonstrating performance against specific acceptance criteria.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.