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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 K932283
Device Name PATIENT EXAMINATION GLOVES
Applicant
Eac Rubber Industries (M) Sdn. Bhd.
P.O. Box 240
46720 Petaling Jaya
Malaysia,  MY
Applicant Contact EWE HUM
Correspondent
Eac Rubber Industries (M) Sdn. Bhd.
P.O. Box 240
46720 Petaling Jaya
Malaysia,  MY
Correspondent Contact EWE HUM
Regulation Number880.6250
Classification Product Code
LYY  
Date Received05/07/1993
Decision Date 05/02/1994
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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