The following data is part of a premarket notification filed by Glormed Intl., Inc. with the FDA for Vinyl Patient Examination Glove, Powdered.
| Device ID | K981360 |
| 510k Number | K981360 |
| Device Name: | VINYL PATIENT EXAMINATION GLOVE, POWDERED |
| Classification | Vinyl Patient Examination Glove |
| Applicant | GLORMED INTL., INC. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Contact | Janna Tucker |
| Correspondent | Janna Tucker GLORMED INTL., INC. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-14 |
| Decision Date | 1998-10-15 |