K-number	K221667
Device name	Non Sterile Powder Free Latex Examination Glove
Applicant	New Era Medicare Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	Oct 28, 2022
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Non Sterile Powder Free Latex Examination Glove

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