The following data is part of a premarket notification filed by C.r. Trading, Inc. with the FDA for Latex Examination Glove.
Device ID | K890462 |
510k Number | K890462 |
Device Name: | LATEX EXAMINATION GLOVE |
Classification | Latex Patient Examination Glove |
Applicant | C.R. TRADING, INC. 1314 JADWIN AVE. Richland, WA 99352 |
Contact | Garry L Quinn |
Correspondent | Garry L Quinn C.R. TRADING, INC. 1314 JADWIN AVE. Richland, WA 99352 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-30 |
Decision Date | 1989-03-24 |