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510(k) Data Aggregation
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A patient examination glove is a disposable device intended for medical purposes that is worn on the exar iner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Non-Sterile Vinyl Examination Gloves
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets any acceptance criteria. The document is a 510(k) clearance letter from the FDA for "Vinyl Exam Gloves, Powder-Free," indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.
The information provided only discusses:
- The FDA's decision to allow the marketing of the device.
- The regulatory class and product code.
- General controls provisions.
- Directions for further information or questions regarding labeling, promotion, and advertising.
- The "Indications For Use" statement for the gloves.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as this information is not present in the provided text.
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(21 days)
A 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.
PRE-POWDERED NON-STERILE. VINYL EXAMINATION GLOVES
The provided text is a 510(k) clearance letter from the FDA to Shanqhai Champion Plastic Products Co., Ltd. for pre-powdered vinyl examination gloves. It is a regulatory document and does not contain information about the acceptance criteria or a study proving the device meets those criteria. Such studies and criteria are typically found in the 510(k) submission itself, of which this letter is only the clearance response.
Therefore, I cannot provide the requested information based on the given input. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance study results against specific acceptance criteria.
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