Name: Predicase
Price: 199 USD

K-number	K031768
Device name	BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
Applicant	Perusahaan Getah Asas Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Aug 1, 2003
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED

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