Name: Predicase
Price: 199 USD

K-number	K163041
Device name	Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E
Applicant	Pt. Medisafe Technologies
Product code	LZA
Device class	Class I
Decision date	Feb 22, 2017
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Powder Free Polychloroprene Examination Gloves-Pink with Aloe Vera and Vitamin E

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