The following data is part of a premarket notification filed by Fitone Latex Products Co., Ltd. Guangdong with the FDA for Single-use Medical Latex Examination Gloves (lg100).
| Device ID | K222693 |
| 510k Number | K222693 |
| Device Name: | Single-use Medical Latex Examination Gloves (LG100) |
| Classification | Latex Patient Examination Glove |
| Applicant | Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong Road, Lingbei Industrial Zone, Suixi Zhanjiang, CN 524338 |
| Contact | Christine Ou |
| Correspondent | Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. Room1308,Baohua International Plaza,West Guangzhong Road 555 Jingan District Shanghai, CN 200072 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-06 |
| Decision Date | 2022-09-24 |