The following data is part of a premarket notification filed by Guangzhou Junda Gloves Co., Ltd with the FDA for Medical Examination Gloves.
| Device ID | K212311 |
| 510k Number | K212311 |
| Device Name: | Medical Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Guangzhou Junda Gloves Co., Ltd No.38 Heting Fengwei Industrial Zone Guangzhou, CN 510470 |
| Contact | Olivia Chen |
| 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 | 2021-07-23 |
| Decision Date | 2021-10-21 |