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 |