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 |