The following data is part of a premarket notification filed by Liu's Glove Corp. with the FDA for Latex Examination Gloves.
| Device ID | K891718 |
| 510k Number | K891718 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | LIU'S GLOVE CORP. ROOM 8, 6TH FL, NO. 186 SEC. 4, NANKING E. RD. Taipei, Taiwan, R.o.c., TW |
| Contact | T. T Chang |
| Correspondent | T. T Chang LIU'S GLOVE CORP. ROOM 8, 6TH FL, NO. 186 SEC. 4, NANKING E. RD. Taipei, 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 | 1989-03-21 |
| Decision Date | 1989-04-26 |