Name: Predicase
Price: 199 USD

K-number	K952589
Device name	ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES
Applicant	Shield Gloves Manufacturer (M) Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Aug 11, 1995
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES

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