The following data is part of a premarket notification filed by Hebei Hongsen Plastics Technology Co, Ltd with the FDA for Powder Free Nitrile Gloves (white), Powder Free Nitrile Gloves (cobalt Blue), Powder Free Nitrile Gloves (black), Powder Free Nitrile Gloves (ice Blue).
| Device ID | K150340 |
| 510k Number | K150340 |
| Device Name: | POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD ESTERN INDUSTRIAL ZONE Nangong City, CN 051800 |
| Contact | Shaozhang Nan |
| Correspondent | Ray Wang Beijing Believe Tech. Service Co., Ltd. 1-202, Build 3, Beijing New World, No.5 Chaoyang Rd., Chaoyang District Beijing, CN 100024 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-11 |
| Decision Date | 2015-06-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10699320452865 | K150340 | 000 |
| 00810052972572 | K150340 | 000 |
| 00810052972602 | K150340 | 000 |
| 00810052972633 | K150340 | 000 |
| 00810052975368 | K150340 | 000 |
| 10699320452810 | K150340 | 000 |
| 10699320452827 | K150340 | 000 |
| 10699320452834 | K150340 | 000 |
| 10699320452841 | K150340 | 000 |
| 10699320452858 | K150340 | 000 |
| 00810052972541 | K150340 | 000 |