The following data is part of a premarket notification filed by Shanxi Hongjin Plastic Technology Co., Ltd. with the FDA for Powder Free Nitrile Examination Gloves (blue), Tested For Use With Chemotherapy Drugs.
| Device ID | K211604 |
| 510k Number | K211604 |
| Device Name: | Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shanxi Hongjin Plastic Technology Co., Ltd. Coal Bed Gas Industrial Zone, Qu'e Town, Daning County Lifen, CN 042300 |
| Contact | Wu Zhigang |
| Correspondent | Kathy Liu Hongray USA Medical Products Inc. 3973 Schaefer Avenue 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 | 2021-05-25 |
| Decision Date | 2021-10-27 |