Name: Predicase
Price: 199 USD

K-number	K192635
Device name	Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)
Applicant	Wrp Asia Pacific Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Jan 17, 2020
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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Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)

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