The following data is part of a premarket notification filed by Guangdong Kingfa Sci.&tech. Co., Ltd. with the FDA for Powder-free Latex Examination Gloves.
| Device ID | K222612 |
| 510k Number | K222612 |
| Device Name: | Powder-Free Latex Examination Gloves |
| Classification | Latex Patient Examination Glove |
| Applicant | Guangdong Kingfa Sci.&Tech. Co., Ltd. No.28, Delong Ave., Shijiao Town, Qingcheng District Qingyuan, CN 511545 |
| Contact | Xiaoge Yu |
| Correspondent | Xiaoge Yu Guangdong Kingfa Sci.& Tech.Co., Ltd. No.28, Delong Ave., Shijiao Town, Qingcheng District Qingyuan, CN 511545 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-30 |
| Decision Date | 2022-11-25 |