The following data is part of a premarket notification filed by Long Far Industry Co., Ltd. with the FDA for Proson Patient Examination Gloves.
| Device ID | K893076 |
| 510k Number | K893076 |
| Device Name: | PROSON PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | LONG FAR INDUSTRY CO., LTD. 16 REN YIH LANE HEH MING VILLAGE SHIOW Shoei Hsiang Changhu, TW |
| Contact | Karen Lim |
| Correspondent | Karen Lim LONG FAR INDUSTRY CO., LTD. 16 REN YIH LANE HEH MING VILLAGE SHIOW Shoei Hsiang Changhu, TW |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-13 |
| Decision Date | 1989-07-31 |