K-number	K944873
Device name	TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES
Applicant	Baxter Healthcare Corp
Product code	LYZ
Device class	Class I
Decision date	Mar 31, 1995
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES

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