K-number	K992675
Device name	PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
Applicant	Wear Safe Malaysia Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Jan 20, 2000
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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PATIENT NITRILE EXAMINATION GLOVES (POWDERED)

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