Name: Predicase
Price: 199 USD

K-number	K211310
Device name	AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)
Applicant	Megine Industries Sdn Bhd
Product code	LZA
Device class	Class I
Decision date	Jun 16, 2021
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange)

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