The following data is part of a premarket notification filed by Overseas Import & Export Dist. with the FDA for Sas Rubber Products Co./latex Examination Gloves.
Device ID | K911939 |
510k Number | K911939 |
Device Name: | SAS RUBBER PRODUCTS CO./LATEX EXAMINATION GLOVES |
Classification | Latex Patient Examination Glove |
Applicant | OVERSEAS IMPORT & EXPORT DIST. 1749 POTRERO GRANDE DR. STE. G Monterey Park, CA 91754 |
Contact | Wayne Fung |
Correspondent | Wayne Fung OVERSEAS IMPORT & EXPORT DIST. 1749 POTRERO GRANDE DR. STE. G Monterey Park, CA 91754 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-30 |
Decision Date | 1991-11-15 |