The following data is part of a premarket notification filed by Shenzhen Shiqiao Science And Technology Co. Ltd with the FDA for Disposable Nitrile Examination Gloves.
| Device ID | K211264 |
| 510k Number | K211264 |
| Device Name: | Disposable Nitrile Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shenzhen Shiqiao Science And Technology Co. LTD Unit 2105 ,Tower D, Galaxy World Phase II, Minle Community Minzhi Street Shenzhen, CN 518000 |
| Contact | Mikki Wan |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2021-07-30 |