The following data is part of a premarket notification filed by Hebei Hongsen Plastics Technology Co, Ltd with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue.
| Device ID | K131440 |
| 510k Number | K131440 |
| Device Name: | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE |
| Classification | Polymer Patient Examination Glove |
| Applicant | HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD 5 CAREY STREET Pennington, NJ 08534 |
| Contact | Charles Shen |
| Correspondent | Charles Shen HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD 5 CAREY STREET Pennington, NJ 08534 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-05-20 |
| Decision Date | 2013-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50810572001559 | K131440 | 000 |
| 50810572001542 | K131440 | 000 |
| 50810572001535 | K131440 | 000 |
| 50810572001528 | K131440 | 000 |