The following data is part of a premarket notification filed by Better Care Plastic Technology Co.,ltd. with the FDA for Sterile Polyisoprene Powder Free Surgical Gloves.
| Device ID | K171047 |
| 510k Number | K171047 |
| Device Name: | Sterile Polyisoprene Powder Free Surgical Gloves |
| Classification | Surgeon's Gloves |
| Applicant | Better Care Plastic Technology Co.,Ltd. Fuqian Xi Road, West District Of Shenze Industrial Base Shenze County, CN 050000 |
| Contact | Zhu Chunyan |
| Correspondent | Kathy Liu Hongray USA Medical Products Inc 2235 E Francis St Ontario, CA 91761 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-07 |
| Decision Date | 2017-06-22 |
| Summary: | summary |