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The Non-Sterile, Powder-Free Yellow Latex Examination Glove With Tutti Flavour and With Protein Labeling Claim of <50 ug/dm² per 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.

Non-Sterile, Powder-Free Yellow Latex Examination Gloves With Tutti Frutti Flavour and with Protein Labeling Claim of <50 ug/dm² Per Glove

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Non-Sterile, Powder-Free Yellow Latex Examination Gloves with Tutti Frutti Flavour and with Protein Labeling Claim of <50 ug/dm² Per Glove."

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Informs the company about their regulatory responsibilities, general controls, and where to find more information.
• States the intended use of the device.

It does not contain details about specific performance acceptance criteria for the gloves, nor does it describe any study (including sample sizes, ground truth establishment, expert qualifications, or MRMC studies) conducted to demonstrate compliance with such criteria.

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