The following data is part of a premarket notification filed by Shandong Xinshi Medical Products Co., Ltd. with the FDA for Blue Nitrile Powder Free Exam Gloves.
| Device ID | K133325 |
| 510k Number | K133325 |
| Device Name: | BLUE NITRILE POWDER FREE EXAM GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHANDONG XINSHI MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE Chino, CA 91710 |
| Contact | Ray Zhou |
| Correspondent | Ray Zhou SHANDONG XINSHI MEDICAL PRODUCTS CO., LTD. 12390 EAST END AVE Chino, CA 91710 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-29 |
| Decision Date | 2014-08-08 |