Name: Predicase
Price: 199 USD

K-number	K982691
Device name	MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
Applicant	Perusahaan Intan Emas Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	Oct 9, 1998
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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MULTI-COMFORT POWDERED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)

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