The following data is part of a premarket notification filed by Ansell Healthcare Products, Inc. with the FDA for Micro-touch Next Step Powder Free Medical Examination Gloves With Aloe And Glycerol.
Device ID | K023153 |
510k Number | K023153 |
Device Name: | MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL |
Classification | Latex Patient Examination Glove |
Applicant | ANSELL HEALTHCARE PRODUCTS, INC. 1875 HARSH AVENUE, S.E. Massillon, OH 44646 -7199 |
Contact | James R Chatterton |
Correspondent | James R Chatterton ANSELL HEALTHCARE PRODUCTS, INC. 1875 HARSH AVENUE, S.E. Massillon, OH 44646 -7199 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-23 |
Decision Date | 2002-11-13 |
Summary: | summary |