The following data is part of a premarket notification filed by Guangdong Gymda Medical Technology Co.,ltd with the FDA for Medical Examination Gloves (tested For Use With Chemotherapy).
| Device ID | K212506 |
| 510k Number | K212506 |
| Device Name: | Medical Examination Gloves (Tested For Use With Chemotherapy) |
| Classification | Polymer Patient Examination Glove |
| Applicant | GUANGDONG GYMDA MEDICAL TECHNOLOGY CO.,LTD No.13, Quan'an Third Road, Phase 2 Of High-tech Zone, Nanxio Shaoguan City, CN 512400 |
| Contact | Olivia Chen |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East 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 | 2021-08-09 |
| Decision Date | 2021-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974538550174 | K212506 | 000 |
| 06974538550167 | K212506 | 000 |
| 06974538550150 | K212506 | 000 |
| 06974538550143 | K212506 | 000 |