Name: Predicase
Price: 199 USD

K-number	K991742
Device name	NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O
Applicant	Yty Industry (Manjung) Sdn Bhd
Product code	LYY
Device class	Class I
Decision date	Jun 21, 1999
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O

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