The following data is part of a premarket notification filed by Universal Gloves Corp. with the FDA for Modified Safe Vinyl Examination Gloves.
| Device ID | K900092 |
| 510k Number | K900092 |
| Device Name: | MODIFIED 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 | 1990-01-08 |
| Decision Date | 1990-03-08 |