The following data is part of a premarket notification filed by Hebei Titans Medical Supply Technology Group.,ltd. with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue.
| Device ID | K163553 |
| 510k Number | K163553 |
| Device Name: | Powder Free Nitrile Patient Examination Gloves, Blue |
| Classification | Polymer Patient Examination Glove |
| Applicant | HEBEI TITANS MEDICAL SUPPLY TECHNOLOGY GROUP.,LTD. EAST OF JINGQIANG COMMUNITY, DAQING ST, XINGTAI Nangong, CN 051800 |
| Contact | Shaozhang Nan |
| Correspondent | Ray Wang Beijing Believe Tech. Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., TongZhou District Beijing, CN |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-05-22 |
| Summary: | summary |