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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgeon'S Gloves
510(k) Number K231902
Device Name GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
Applicant
Ansell Healthcare
2301 Robb Dr.
Reno,  NV  89523
Applicant Contact Carson Delaloye
Correspondent
Ansell Healthcare
2301 Robb Dr.
Reno,  NV  89523
Correspondent Contact Carson Delaloye
Regulation Number878.4460
Classification Product Code
KGO  
Subsequent Product Code
OPJ  
Date Received06/28/2023
Decision Date 10/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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