Name: Predicase
Price: 199 USD

K-number	K000985
Device name	MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS
Applicant	Matang Mfg. Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	Apr 24, 2000
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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MATANG POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS

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