Name: Predicase
Price: 199 USD

K-number	K221378
Device name	Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
Applicant	Tec Gloves Industry (M) Sdn.Bhd.
Product code	LZA
Device class	Class I
Decision date	Sep 30, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile

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