Name: Predicase
Price: 199 USD

K-number	K212349
Device name	Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves
Applicant	Medi Legion Sdn.Bhd
Product code	LZA
Device class	Class I
Decision date	Dec 10, 2021
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves

Everything you need for a 510(k) submission. Nothing you don't.