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FDA 510(k), K120066, POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
FDA 510(k), K120066, POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
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510(K) Number: K120066
Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
Manufacturer: CHO S FONG
Device Classification Name: Polymer Patient Examination Glove
Regulation Number: LZA
Classification Product Code: KXA
Date Received: 01/09/2012
Decision Date: 11/16/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
Manufacturer: CHO S FONG
Device Classification Name: Polymer Patient Examination Glove
Regulation Number: LZA
Classification Product Code: KXA
Date Received: 01/09/2012
Decision Date: 11/16/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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