The following data is part of a premarket notification filed by Shandong Taixiang Medical Products Co., Ltd. with the FDA for Powder-free Vinyl Patient Examination Gloves, Non-sterile.
| Device ID | K120230 |
| 510k Number | K120230 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, NON-STERILE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHANDONG TAIXIANG MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Contact | Ray Zhou |
| Correspondent | Ray Zhou SHANDONG TAIXIANG MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-25 |
| Decision Date | 2012-07-27 |
| Summary: | summary |