The following data is part of a premarket notification filed by Universal Gloves Corp. with the FDA for Disposable Synthetic Patient Exmination Gloves, Powder Free.
| Device ID | K980093 |
| 510k Number | K980093 |
| Device Name: | DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | UNIVERSAL GLOVES CORP. 10 SHIN JIUNN RD., SHIN YING INDUSTRIAL ZONE, Shin Ying, Tainan Hsien, TW 730 |
| Contact | John Chen |
| Correspondent | John Chen UNIVERSAL GLOVES CORP. 10 SHIN JIUNN RD., SHIN YING INDUSTRIAL ZONE, Shin Ying, Tainan Hsien, TW 730 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-09 |
| Decision Date | 1998-03-02 |
| Summary: | summary |