The following data is part of a premarket notification filed by Daw Shin Industrial Co., Ltd. with the FDA for Patient Examination Gloves (non-sterile Vinyl).
| Device ID | K890851 |
| 510k Number | K890851 |
| Device Name: | PATIENT EXAMINATION GLOVES (NON-STERILE VINYL) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | DAW SHIN INDUSTRIAL CO., LTD. 11F., 52, WU FU 3RD ROAD KAOHSIUNG 80119 Taiwan, TW |
| Contact | Max Ma |
| Correspondent | Max Ma DAW SHIN INDUSTRIAL CO., LTD. 11F., 52, WU FU 3RD ROAD KAOHSIUNG 80119 Taiwan, TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-21 |
| Decision Date | 1989-04-25 |