The following data is part of a premarket notification filed by Glorious Wealth Co., Ltd. with the FDA for Patient Examination Glove (latex).
| Device ID | K892012 |
| 510k Number | K892012 |
| Device Name: | PATIENT EXAMINATION GLOVE (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | GLORIOUS WEALTH CO., LTD. NO. 12, LANE 563, SEC. 4 CHUNG SUN ROAD, HSICHOU Chang Hwa, Taiwan, R.o.c., TW |
| Contact | Dennis E Lane |
| Correspondent | Dennis E Lane GLORIOUS WEALTH CO., LTD. NO. 12, LANE 563, SEC. 4 CHUNG SUN ROAD, HSICHOU Chang Hwa, Taiwan, R.o.c., TW |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-30 |
| Decision Date | 1989-05-12 |