Name: Predicase
Price: 199 USD

K-number	K172442
Device name	Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Applicant	Hartalega NGC Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Nov 6, 2017
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 and Tested for Use with Chemotherapy Drugs (Blue)

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