The following data is part of a premarket notification filed by Ka Hung Development Ltd. with the FDA for Patient Examination Gloves (non Sterile).
| Device ID | K895657 |
| 510k Number | K895657 |
| Device Name: | PATIENT EXAMINATION GLOVES (NON STERILE) |
| Classification | Latex Patient Examination Glove |
| Applicant | KA HUNG DEVELOPMENT LTD. ROOM 503/504, HANG SENG BANK 200. HENNESSY ROAD Wanchai, Hong Kong, HK |
| Contact | Yik Ling |
| Correspondent | Yik Ling KA HUNG DEVELOPMENT LTD. ROOM 503/504, HANG SENG BANK 200. HENNESSY ROAD Wanchai, 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 | 1989-09-20 |
| Decision Date | 1989-12-11 |