(39 days)
Olymer Examination Glove , Powder Free Non Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purpose that is worn on the examiner's hand or finger or prevent contamination between patient and examiner.
The Polymer Examination Gloves, Powder Free, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document describes the PT. MAHAKARYA INTI BUANA Polymer Examination Gloves, Powder Free, Non Sterile. The provided information focuses on non-clinical performance data and does not include details on clinical studies or AI-driven aspects.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA (implied by "Meets" or specific values) | REPORTED DEVICE PERFORMANCE |
|---|---|---|---|
| Dimension | D 3578 -01 ae² | Meets D 3578 -01 ae² | Meets |
| Physical Properties | D 3578 -01 ae² | Meets D 3578 -01 ae² | Meets |
| Freedom from Pinholes | D 3578 -01 ae² | ||
| FDA 21 CFR 800.20 | Meets D 3578 -01 ae² and FDA 21 CFR 800.20 | Meets | |
| Powder Free Residue | D 3578 -01 ae² | ||
| D6124 - 01 |
§ 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.