The following data is part of a premarket notification filed by Guangdong Gymda Medical Technology Co., Ltd with the FDA for Medical Examination Gloves.
| Device ID | K212078 |
| 510k Number | K212078 |
| Device Name: | Medical Examination Gloves |
| Classification | Polymer Patient Examination Glove |
| Applicant | Guangdong Gymda Medical Technology Co., Ltd No.13, Quan'an Third Road, Phase 2 Of High-tech Zone Nanxiong, CN 512400 |
| 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 | 2021-07-02 |
| Decision Date | 2021-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974538550136 | K212078 | 000 |
| 06974538550129 | K212078 | 000 |
| 06974538550112 | K212078 | 000 |
| 06974538550105 | K212078 | 000 |