(76 days)
Polymer Coated Latex Examination Glove, Powder Free, Non Sterile is a disposable device and made of Natural Rubber Latex Coated with Polymer Intended for Medical purpose that is worn on the Examiner's hand or finger to prevent contamination between patient and examiner
The Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile meets all the requirements of ASTM standard D 3578-01 a22 and FDA 1000 ml Water Leak Test.
The document describes the Polymer Coated Latex Examination Gloves, Powder Free, Non Sterile, manufactured by PT Mandiri Inti Buana. The device is a disposable glove intended for medical purposes to prevent contamination between patient and examiner.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA (Implied by "Meets" or specified values) | DEVICE PERFORMANCE |
|---|---|---|---|
| Dimension | D 3587 -01 ae² | Conformance to ASTM D 3587 -01 ae² | Meets (Conforms to ASTM D 3587 -01 ae²) |
| Physical Properties | D 3587 -01 ae² | Conformance to ASTM D 3587 -01 ae² | Meets (Conforms to ASTM D 3587 -01 ae²) |
| Freedom from Pinholes | D 3587 -01 ae² & FDA 21 CFR 800.20 | Conformance to ASTM D 3587 -01 ae² & FDA 21 CFR 800.20 | Meets (Conforms to ASTM D 3587 -01 ae² & FDA test) |
| Powder Free Residue | D 3587 -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.