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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Latex Patient Examination Glove
510(k) Number K895227
Device Name SKINTEX LATEX EXAMINATION GLOVES
Applicant
Fabrica DE Plasticos Mexicanos Del Sur. S.A.
C/O Goma, Inc.
7777 Alvarado Rd.
La Mesa,  CA  92041
Applicant Contact JORGE FINKELBERG
Correspondent
Fabrica DE Plasticos Mexicanos Del Sur. S.A.
C/O Goma, Inc.
7777 Alvarado Rd.
La Mesa,  CA  92041
Correspondent Contact JORGE FINKELBERG
Regulation Number880.6250
Classification Product Code
LYY  
Date Received08/14/1989
Decision Date 11/16/1989
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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