Name: Predicase
Price: 199 USD

K-number	K211758
Device name	Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)
Applicant	Hartalega NGC Sdn. Bhd.
Product code	OPC
Device class	Class I
Decision date	Aug 3, 2021
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)

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