Disinfectants Cleared for Reusable Devices
The FDA Approves 17 Sterilizing and Disinfecting Products for Reprocessing Medical Devices
The Food and Drug Administration (FDA) released a list of the latest approved disinfectants for reprocessing medical devices as of January 28, 2000. The following company products were approved through the 510(k) process:
Advanced Sterilization Products:
- Cidex OPA Solution High Level Disinfectant, (0.55% ortho-phthaldehyde), K991487
Sporicidin International:
- Sporicidin Sterilizing and Disinfecting Solution (0.95% glut and 1.64% phenol/phenate), K983194
Johnson & Johnson Medical Products, Inc.
- Cidex Activated Dialdehyde Solution (2.4% glut), K924434
- Cidex Formula 7 Long-Life Activated Dialdehyde Solution (2.5% glut), K924334
- Cidex Plus 28 Day Solution (3.4% glut), K923744
Metrex Research, Inc.:
- Metricide Activated Dialdehyde Solution (2.6% glut), K930284
- Metricide Plus 30 Long-Life Activated Dialdehyde Solution (3.4% glut), K931592
- Metricide 28 Day Long-Life Activated Dialdehyde Solution (2.5% glut), K931052
Cottrell Limited:
- Procide 14 N.S. (2.4% glut), K932922
- Omnicide Long-Life Activated Dialdehyde Solution (2.4% glut), K932922
- Omnicide Plus (3.4% glut), K932922
Wave Energy Systems:
- Wavicide --01 (2.5% glut), K914749
STERIS Corporation:
- STERIS 20 Sterilant (0.2% peracetic acid), K875280
Minntech Corporation:
- Peract 20 Liquid Sterilant/Disinfectant (0.08% peroxyacetic acid and 1.0% hydrogen peroxide), K960513
Reckitt & Colman, Inc.:
- Sporox Sterilizing & Disinfection Solution (7.5% hydrogen peroxide), K970230
MedSci, Inc.:
- MedSci 3% Glutaraldehyde (3% glut), K974062
Cetylite Industries, Inc.:
- Cetylcide-G Concentrate and Diluent Concentrate (3.2% glut), K974188
More information can be obtained on the Internet at http://www.fda.gov/cdrh/ode/germlab.html.
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