Name: Predicase
Price: 199 USD

K-number	K192232
Device name	Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)
Applicant	Hartalega NGC Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Nov 8, 2019
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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Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White)

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