Name: Predicase
Price: 199 USD

K-number	K211667
Device name	Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)
Applicant	Changzhou Universal Medical Equipment Co., Ltd.
Product code	LAZ
Device class	Class I
Decision date	Sep 23, 2021
Decision	Substantially Equivalent
Regulation	862.3280

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Source

View the full FDA submission: accessdata.fda.gov

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Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile)

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