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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Polymer Patient Examination Glove
510(k) Number K261793
Device Name Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
Applicant
Maxter Healthcare, Inc.
14559 County Rd. 48
Rosharon,  TX  77583
Applicant Contact Sajeev Joseph
Correspondent
Maxter Healthcare, Inc.
14559 County Rd. 48
Rosharon,  TX  77583
Correspondent Contact Sajeev Joseph
Regulation Number880.6250
Classification Product Code
LZA  
Subsequent Product Codes
LZC   OPJ   QDO  
Date Received05/29/2026
Decision Date 09/09/2026
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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