Name: Predicase
Price: 199 USD

K-number	K212482
Device name	Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
Applicant	Sri Trang Gloves (Thailand) Public Company Limited
Product code	LYY
Device class	Class I
Decision date	Aug 9, 2022
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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Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White

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