The following data is part of a premarket notification filed by Jiangxi Zhonghong Pulin Medical Products Co., Ltd with the FDA for Vinyl Patient Examination Gloves.
Device ID | K182117 |
510k Number | K182117 |
Device Name: | Vinyl Patient Examination Gloves |
Classification | Vinyl Patient Examination Glove |
Applicant | Jiangxi Zhonghong Pulin Medical Products Co., Ltd Yinsha Wan Industrial Park, High-tech Industrial Zone Of Hukou County Jiu Jiang, CN 332000 |
Contact | Joe Zhang |
Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-06 |
Decision Date | 2018-10-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06974196380007 | K182117 | 000 |