The following data is part of a premarket notification filed by Plymouth Ltd. with the FDA for Latex Patient Examination Glove.
| Device ID | K895497 |
| 510k Number | K895497 |
| Device Name: | LATEX PATIENT EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | PLYMOUTH LTD. 34/F., CHINA RESOURCES BLDG. 26 HARBOUR ROAD Wanchai, Hong Kong, HK |
| Contact | Bing Quan |
| Correspondent | Bing Quan PLYMOUTH LTD. 34/F., CHINA RESOURCES BLDG. 26 HARBOUR 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 | 1989-08-28 |
| Decision Date | 1989-11-21 |