The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Hypoallergenic Powdered Ambidextrous Coagulatn Dipped Latex Examination Glove.
Device ID | K953379 |
510k Number | K953379 |
Device Name: | HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE |
Classification | Latex Patient Examination Glove |
Applicant | ANSELL, INC. 1500 INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
Contact | Kay Smith |
Correspondent | Kay Smith ANSELL, INC. 1500 INDUSTRIAL RD. POST OFFICE BOX 1252 Dothan, AL 36302 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-19 |
Decision Date | 1995-09-27 |