The following data is part of a premarket notification filed by Shinemound Enterprise, Inc. with the FDA for Sensi-pro, Disposable Pre-powdered Synthetic Vinyl Patient Examination Gloves With Beige Pigment Additives.
| Device ID | K994248 |
| 510k Number | K994248 |
| Device Name: | SENSI-PRO, DISPOSABLE PRE-POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES WITH BEIGE PIGMENT ADDITIVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHINEMOUND ENTERPRISE, INC. 17A STERLING RD. North Billerica, MA 01862 |
| Contact | Huan-chung Li |
| Correspondent | Huan-chung Li SHINEMOUND ENTERPRISE, INC. 17A STERLING RD. North Billerica, MA 01862 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-16 |
| Decision Date | 2000-01-28 |