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 |