The following data is part of a premarket notification filed by Shanghai Shengda Medical Applications Co., Ltd with the FDA for Powder Free Vinyl Examination Gloves.
| Device ID | K211103 |
| 510k Number | K211103 |
| Device Name: | Powder Free Vinyl Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Shanghai Shengda Medical Applications Co., Ltd No. 608 Xingwen Road, North Development Zone, Jiading District Shanghai, CN 201815 |
| Contact | Ying Su |
| Correspondent | Charles Shen Manton Business And Technology Services 37 Winding Ridge Oakland, NJ 07436 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-13 |
| Decision Date | 2021-11-04 |