The following data is part of a premarket notification filed by Shinemound Enterprise, Inc. with the FDA for Lightly Powdered Vinyl Synthetic Examination Gloves.
| Device ID | K972104 |
| 510k Number | K972104 |
| Device Name: | LIGHTLY POWDERED VINYL SYNTHETIC EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHINEMOUND ENTERPRISE, INC. 34 LINNELL CIRCLE Billerica, MA 01821 |
| Contact | Huan-chung Li |
| Correspondent | Huan-chung Li SHINEMOUND ENTERPRISE, INC. 34 LINNELL CIRCLE Billerica, MA 01821 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-04 |
| Decision Date | 1997-08-15 |