K-number	K892751
Device name	PATIENT EXAMINATION GLOVES (DENTAL)
Applicant	Baxter Healthcare Corp
Product code	LYY
Device class	Class I
Decision date	Jul 14, 1989
Decision	Substantially Equivalent
Regulation	880.6250

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View the full FDA submission: accessdata.fda.gov

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PATIENT EXAMINATION GLOVES (DENTAL)

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