The following data is part of a premarket notification filed by Syntex Healthcare Products Co., Ltd with the FDA for Powder-free Nitrile Examination Gloves (blue), Tested For Use With Chemotherapy Drugs.
| Device ID | K182156 |
| 510k Number | K182156 |
| Device Name: | Powder-Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Syntex Healthcare Products Co., Ltd No. 1, Fanjiazhuang, Industrial Zone, Xinji City, Hebei Province China 052360 Xinji City, CN 052360 |
| Contact | Qiao Zhiqiang |
| Correspondent | Kathy Liu Hongray USA Medical Products Inc 3973 Schaefer Avenue, Chino, CA 91810, USA Chino, CA 91810 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-09 |
| Decision Date | 2018-12-10 |
| Summary: | summary |