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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vinyl Patient Examination Glove
510(k) Number K944873
Device Name TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES
Applicant
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Applicant Contact INGRID M HOOS
Correspondent
Baxter Healthcare Corp
1500 Waukegan Rd.
Bldg. K
Mcgaw Park,  IL  60085
Correspondent Contact INGRID M HOOS
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received10/03/1994
Decision Date 03/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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