The following data is part of a premarket notification filed by United Cargo System, Inc. with the FDA for Patient Examination Gloves (latex).
Device ID | K891876 |
510k Number | K891876 |
Device Name: | PATIENT EXAMINATION GLOVES (LATEX) |
Classification | Latex Patient Examination Glove |
Applicant | UNITED CARGO SYSTEM, INC. 20605 ANNALEE AVE. Carson, CA 90746 |
Contact | Felix Fu |
Correspondent | Felix Fu UNITED CARGO SYSTEM, INC. 20605 ANNALEE AVE. Carson, CA 90746 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-28 |
Decision Date | 1989-07-14 |