The following data is part of a premarket notification filed by Shanghai Industrial Investment Co. Ltd. with the FDA for Patient Exam Gloves(mfg: Shanghai Hua Ling Lat Fac.
| Device ID | K893695 |
| 510k Number | K893695 |
| Device Name: | PATIENT EXAM GLOVES(MFG: SHANGHAI HUA LING LAT FAC |
| Classification | Latex Patient Examination Glove |
| Applicant | SHANGHAI INDUSTRIAL INVESTMENT CO. LTD. 173-174 GLOUCESTER ROAD Hong Kong, HK |
| Contact | Liang Ren-qi |
| Correspondent | Liang Ren-qi SHANGHAI INDUSTRIAL INVESTMENT CO. LTD. 173-174 GLOUCESTER ROAD Hong Kong, HK |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-16 |
| Decision Date | 1989-09-13 |