The following data is part of a premarket notification filed by Tactyl Technologies, Inc. with the FDA for Tactylon Powder Free Examination Glove.
Device ID | K955464 |
510k Number | K955464 |
Device Name: | TACTYLON POWDER FREE EXAMINATION GLOVE |
Classification | Polymer Patient Examination Glove |
Applicant | TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
Contact | Jorge Haider |
Correspondent | Jorge Haider TACTYL TECHNOLOGIES, INC. 2595 COMMERCE WAY Vista, CA 92083 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-30 |
Decision Date | 1996-04-25 |
Summary: | summary |