The following data is part of a premarket notification filed by Nantong Ruchang Latex Products Co., Ltd. with the FDA for Patient Examination Gloves.
| Device ID | K893163 |
| 510k Number | K893163 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | NANTONG RUCHANG LATEX PRODUCTS CO., LTD. HUNA ZHEN RUDONG COUNTY, JIANGSU China, CN |
| Contact | Wu Wenhan |
| Correspondent | Wu Wenhan NANTONG RUCHANG LATEX PRODUCTS CO., LTD. HUNA ZHEN RUDONG COUNTY, JIANGSU 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 | 1989-04-14 |
| Decision Date | 1989-08-10 |