The following data is part of a premarket notification filed by Ansell Pacific, Inc. with the FDA for Patient Examination Gloves (latex).
Device ID | K892570 |
510k Number | K892570 |
Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
Classification | Latex Patient Examination Glove |
Applicant | ANSELL PACIFIC, INC. 4750 SOUTH PARK AVE. Tucson, AZ 85714 |
Contact | Fred Dietsch |
Correspondent | Fred Dietsch ANSELL PACIFIC, INC. 4750 SOUTH PARK AVE. Tucson, AZ 85714 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-10 |
Decision Date | 1989-07-14 |