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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 K891356
Device Name PATIENT EXAMINATION GLOVES (VINYL)
Applicant
Pm Gloves, Inc.
14145 Proctor Ave. Suite #21
City Of Industry,  CA  91746
Applicant Contact LIN
Correspondent
Pm Gloves, Inc.
14145 Proctor Ave. Suite #21
City Of Industry,  CA  91746
Correspondent Contact LIN
Regulation Number880.6250
Classification Product Code
LYZ  
Date Received03/10/1989
Decision Date 04/13/1989
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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