Name: Predicase
Price: 199 USD

K-number	K212716
Device name	Dermoaroma Disposable Nitrile Examination Glove
Applicant	Chuzhou Harmony Gloves Medical Technology Co.,Ltd
Product code	LZA
Device class	Class I
Decision date	Dec 27, 2021
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Dermoaroma Disposable Nitrile Examination Glove

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