K-number	K213681
Device name	Ivory Glove Powder-Free Nitrile Examination Gloves
Applicant	Ivory Gloves Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Apr 21, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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Ivory Glove Powder-Free Nitrile Examination Gloves

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