(91 days)
Powder Free Latex Examination Gloves, Non-Sterile (Contains 50 micrograms or less of Water Extractable Protein per gram) is a disposable device and made of Natural Rubber Latex intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
The Powder Free Latex Examination Gloves, Non Sterile (Contains 50 micrograms or less of Total Water Extractable Protein per gram) meets all the requirements of ASTM standard D 3578 - 01a 22 and FDA 1000 ml Water Leak Test.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PT. Mandiri Inti Buana examination gloves:
Overview:
This submission describes a Class I medical device (Powder Free Latex Examination Gloves, Non-Sterile) and seeks a 510(k) clearance based on substantial equivalence to legally marketed predicate devices. The "study" here refers to non-clinical performance testing conducted to demonstrate compliance with established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | ACCEPTANCE CRITERIA (STANDARDS) | REPORTED DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | D 3578 - 01ae2 | Meets |
| Physical Properties | D 3578 - 01ae2 | Meets |
| Freedom from Pinholes | D 3578 - 01ae2, FDA 21 CFR 800.20 (FDA 1000 ml Water Leak Test) | Meets |
| Powder Residue | D 3578 - 01ae2, D 6124 - 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.