The following data is part of a premarket notification filed by Zibo Intco Medical Products Co., Ltd. with the FDA for Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue Color.
| Device ID | K132201 |
| 510k Number | K132201 |
| Device Name: | SYNMAX SYNTHETIC EXAMINATION VINYL GLOVES, POWDER FREE, BLUE COLOR |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO INTCO MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE. Chino, CA 91710 |
| Contact | John Zhao |
| Correspondent | John Zhao ZIBO INTCO 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 | 2013-07-16 |
| Decision Date | 2013-11-27 |
| Summary: | summary |