The following data is part of a premarket notification filed by Shenyi(shandong) Plastic Products, Co.ltd with the FDA for Powder-free Clear Vinyl Patient Examination Gloves.
| Device ID | K142892 |
| 510k Number | K142892 |
| Device Name: | Powder-free Clear Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Shenyi(Shandong) Plastic Products, Co.Ltd No.23 Fenghuang Road Linzi, CN 255400 |
| Contact | Tyler Li |
| Correspondent | Ray Zhou BASIC MEDICAL INDUSTRIES, INC. 12390 East End Ave Chino, CA 91710 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-03 |
| Decision Date | 2015-03-25 |
| Summary: | summary |