Name: Predicase
Price: 199 USD

K-number	K211865
Device name	Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Applicant	Liao Ning Shangwei Medical Products Co., Ltd.
Product code	LYZ
Device class	Class I
Decision date	Dec 20, 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 Vinyl Patient Examination Gloves, Clear (non-colored)

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