The following data is part of a premarket notification filed by Shandong Shouguang Kingliyuan Medical Apparatus & with the FDA for Powder-free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K120797 |
| 510k Number | K120797 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANDONG SHOUGUANG KINGLIYUAN MEDICAL APPARATUS & 916 WEST 21ST STREET Chicago, IL 60608 |
| Contact | Kevin Xu |
| Correspondent | Kevin Xu SHANDONG SHOUGUANG KINGLIYUAN MEDICAL APPARATUS & 916 WEST 21ST STREET Chicago, IL 60608 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-15 |
| Decision Date | 2012-07-27 |
| Summary: | summary |