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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Nitrile Exam Gloves - First Aid Only, Non Sterile, Single Use & Powder Free; Patient Examination Gloves
Classification Name: POLYMER PATIENT EXAMINATION GLOVE
Product Code: LZA
Device Class: 1
Regulation Number: 880.6250
Medical Specialty: General Hospital
Registered Establishment Name: 3A GLOVE SDN. BHD.
Registered Establishment Number: 3025606191
Premarket Submission Number: K230777
Owner/Operator: 3A Glove Sdn. Bhd.
Owner/Operator Number: 10086871
Establishment Operations: Contract Manufacturer; Manufacturer
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