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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Nitrile exam glove; PF nitrile exam glove,blue color
Classification Name: POLYMER PATIENT EXAMINATION GLOVE
Product Code: LZA
Device Class: 1
Regulation Number: 880.6250
Medical Specialty: General Hospital
Registered Establishment Name: XIAMEN COMPOWER MEDICAL TECH. CO., LTD.
Registered Establishment Number: 3008261717
Premarket Submission Number: K152712
Owner/Operator: Xiamen Compower Medical Tech. Co., Ltd.
Owner/Operator Number: 10031696
Establishment Operations: Repackager/Relabeler
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