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510(k) Data Aggregation
(76 days)
FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
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 |
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(39 days)
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
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 |
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