Name: Predicase
Price: 199 USD

K-number	K001837
Device name	NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
Applicant	Shanghai Poseidon Plastic Products Co., Ltd.
Product code	LZA
Device class	Class I
Decision date	Jul 11, 2000
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE

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