The following data is part of a premarket notification filed by Universal Gloves Corp. with the FDA for Comple-safe Vinyl Examination Gloves.
| Device ID | K891369 |
| 510k Number | K891369 |
| Device Name: | COMPLE-SAFE VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | UNIVERSAL GLOVES CORP. RM 5-2, NO. 155, SEC. 1 KEELUNG ROAD, TAIPEI (10546) Taiwan, R.o.c., TW |
| Contact | Charles Chou |
| Correspondent | Charles Chou UNIVERSAL GLOVES CORP. RM 5-2, NO. 155, SEC. 1 KEELUNG ROAD, TAIPEI (10546) 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 | 1989-03-09 |
| Decision Date | 1989-03-29 |