The following data is part of a premarket notification filed by Asia Way Trading, Inc. with the FDA for Non-sterile Patient Examination Gloves (latex).
| Device ID | K892747 |
| 510k Number | K892747 |
| Device Name: | NON-STERILE PATIENT EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | ASIA WAY TRADING, INC. 32107 LINDERO CANYON RD. SUITE 206 WESTLAKE VILLAGE, CA 91361 |
| Contact | BOBBY LIN |
| Correspondent | BOBBY LIN ASIA WAY TRADING, INC. 32107 LINDERO CANYON RD. SUITE 206 WESTLAKE VILLAGE, CA 91361 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-11 |
| Decision Date | 1989-05-22 |