The following data is part of a premarket notification filed by Double Scores Ltd. with the FDA for Patient Exam Gloves(mfg: Jin Ding Zai Jie Latex Gl.
| Device ID | K893696 |
| 510k Number | K893696 |
| Device Name: | PATIENT EXAM GLOVES(MFG: JIN DING ZAI JIE LATEX GL |
| Classification | Latex Patient Examination Glove |
| Applicant | DOUBLE SCORES LTD. SUITE 3502, 35/F., BOND CENTRE EAST TOWER, 89 QUEENSWAY Hong Kong, HK |
| Contact | K. M Wong |
| Correspondent | K. M Wong DOUBLE SCORES LTD. SUITE 3502, 35/F., BOND CENTRE EAST TOWER, 89 QUEENSWAY 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 | 1989-09-29 |