The following data is part of a premarket notification filed by Dezhou Hengchang Medical Technology Co., Ltd. with the FDA for Vinyl/nitrile Blend Exam Glove.
| Device ID | K213634 |
| 510k Number | K213634 |
| Device Name: | Vinyl/Nitrile Blend Exam Glove |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Dezhou Hengchang Medical Technology Co., Ltd. West Side Of South Tiandingfeng Road, Xingtong Sub-district Office, Linyi County, Dezhou City, CN 251500 |
| Contact | Jing Li |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East 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 | 2021-11-17 |
| Decision Date | 2022-02-18 |