The following data is part of a premarket notification filed by Zibo Ling Yun Medical Products Co, Ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Yellow Color.
| Device ID | K143340 |
| 510k Number | K143340 |
| Device Name: | Powder Free Vinyl Patient Examination Gloves, Yellow Color |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Zibo Ling Yun Medical Products Co, Ltd No. 318 Yuming Road Zibo Industrial Park Zibo, CN 255400 |
| Contact | Eric Wang |
| 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 | 2014-11-21 |
| Decision Date | 2015-07-09 |
| Summary: | summary |