The following data is part of a premarket notification filed by Kaohsiung Brothers Products Corp. with the FDA for Patient Examination Gloves (vinyl).
| Device ID | K891336 |
| 510k Number | K891336 |
| Device Name: | PATIENT EXAMINATION GLOVES (VINYL) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | KAOHSIUNG BROTHERS PRODUCTS CORP. 23, KOOSHAN 3RD ROAD Kaohsiung, Taiwan R.o.c., TW |
| Contact | Stonee Chen |
| Correspondent | Stonee Chen KAOHSIUNG BROTHERS PRODUCTS CORP. 23, KOOSHAN 3RD ROAD Kaohsiung, Taiwan R.o.c., TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-10 |
| Decision Date | 1989-09-13 |