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510(k) Data Aggregation
(51 days)
ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.
Powdered vinyl 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.
powdered vinyl patient examination gloves, Clear (Non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
Acceptance Criteria and Device Performance
Characteristics | Standard | Acceptance Criteria | Reported Device Performance |
---|---|---|---|
Dimension | ASTM standard D 5250-06 | Meets requirements of ASTM standard D 5250-06 | Meets |
Physical Properties | ASTM standard D 5250-06 | Meets requirements of ASTM standard D 5250-06 | Meets |
Freedom from pinholes | 21 CFR 800.20 | Meets requirements of 21 CFR 800.20 (and FDA recognition number 2-87 for AQL) | Meets |
Powder Amount | ASTM standard D 5250-06 and D6124-06 (and 21 CFR 800.20) |
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(48 days)
ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.
Powder free vinyl 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.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
The provided text describes the acceptance criteria and performance of "Powder Free Vinyl Patient Examination Gloves, Clear(non-colored)" manufactured by Zhang Jia Gang Fengyuan Plastic Products Co.,Ltd. This is a medical device submission, and the "study" described is the testing conducted to demonstrate substantial equivalence to a predicate device and adherence to relevant standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Characteristics | Acceptance Criteria | Device Performance |
---|---|---|
Dimension | ASTM standard D 5250-06 | Meets |
Physical Properties | ASTM standard D 5250-06 | Meets |
Freedom from pinholes | 21 CFR 800.20 (Water leak test on pinhole AQL) | Meets |
Powder Residual | ASTM standard D 5250-06 and D6124-06 |
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