The following data is part of a premarket notification filed by Shenzhen Guang Ji Emulsion Products Co., Ltd. with the FDA for Latex Examination Gloves.
| Device ID | K900650 |
| 510k Number | K900650 |
| Device Name: | LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | SHENZHEN GUANG JI EMULSION PRODUCTS CO., LTD. LIANTANG EXPLOITATION DISTRICT SHENZHEN China, CN |
| Contact | Cheng Jiang |
| Correspondent | Cheng Jiang SHENZHEN GUANG JI EMULSION PRODUCTS CO., LTD. LIANTANG EXPLOITATION DISTRICT SHENZHEN China, CN |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-09 |
| Decision Date | 1990-03-08 |