The following data is part of a premarket notification filed by Hebei Titans Hongsen Medical Technology Co., Ltd. with the FDA for Powder Free Blue Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs.
| Device ID | K181130 |
| 510k Number | K181130 |
| Device Name: | Powder Free Blue Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs |
| Classification | Patient Examination Glove, Specialty |
| Applicant | Hebei Titans Hongsen Medical Technology Co., LTD. Eastern Industrial Zone Nangong, CN 051800 |
| Contact | Shaozhang Nan |
| Correspondent | Ray Wang Beijing Believe-Med Technology Services Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd. FangShan District Beijing, CN 102401 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-30 |
| Decision Date | 2018-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20850053289495 | K181130 | 000 |
| 20850053289488 | K181130 | 000 |
| 20850053289471 | K181130 | 000 |
| 20850053289464 | K181130 | 000 |