FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

This document is a letter from the FDA regarding a 510(k) premarket notification for "Nitrile Examination Gloves, Pre-Powdered, Blue Glove". It confirms that the device is substantially equivalent to legally marketed predicate devices.

The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in this document. This letter is a regulatory approval document and does not contain details of the performance study itself. It only states that the device was found substantially equivalent for its intended use, which is "for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."

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K Number

K001836

Device Name

NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE

Manufacturer

SHANGHAI POSEIDON PLASTIC PRODUCTS CO., LTD.

Date Cleared

2000-07-26

(40 days)

Product Code