The following data is part of a premarket notification filed by Shijiazhuang Hongzan Plastic Technology Co.,ltd with the FDA for Powder Free Polyethylene Examination Gloves.
| Device ID | K133478 |
| 510k Number | K133478 |
| Device Name: | POWDER FREE POLYETHYLENE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD 3973 SCHAEFER AVE Chino, CA 91710 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu SHIJIAZHUANG HONGZAN PLASTIC TECHNOLOGY CO.,LTD 3973 SCHAEFER 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 | 2013-11-12 |
| Decision Date | 2014-06-02 |
| Summary: | summary |