LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO— 510(k) K011407

Substantially Equivalent

Sempermed USA, Inc.

FDA 510(k) clearance K011407 for LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO, Substantially Equivalent on 2001-09-11. Applicant: Sempermed USA, Inc.. Device class: 1.

Clearance details

Applicant
Sempermed USA, Inc.
Product code
Code LYY
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Palm Harbor, FL, US
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