The following data is part of a premarket notification filed by Daw Shin Industrial Co., Ltd. with the FDA for Non-sterile Vinyl Gloves.
| Device ID | K885346 |
| 510k Number | K885346 |
| Device Name: | NON-STERILE VINYL GLOVES |
| Classification | Patient Examination Glove |
| Applicant | DAW SHIN INDUSTRIAL CO., LTD. 11F. 52, WU FU 3RD ROAD Kaohsiung, TW 80119 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-01-18 |