The following data is part of a premarket notification filed by Ansell, Inc. with the FDA for Ansell Conform Green Examination Gloves.
Device ID | K897081 |
510k Number | K897081 |
Device Name: | ANSELL CONFORM GREEN EXAMINATION GLOVES |
Classification | Vinyl Patient Examination Glove |
Applicant | ANSELL, INC. P.O. BOX 18 LAT KRABANG, BANGKOK 10520 Thailand, TH |
Contact | John W Moushall |
Correspondent | John W Moushall ANSELL, INC. P.O. BOX 18 LAT KRABANG, BANGKOK 10520 Thailand, TH |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-19 |
Decision Date | 1990-03-26 |