The following data is part of a premarket notification filed by Shijiazhuang Great Vision Plastic Products Co., Lt with the FDA for Powder Free Vinyl Patient Examination Gloves.
| Device ID | K102097 |
| 510k Number | K102097 |
| Device Name: | POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT 3973 SCHAEFER AVE Chino, CA 91710 |
| Contact | Kathy Liu |
| Correspondent | Kathy Liu SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT 3973 SCHAEFER 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 | 2010-07-27 |
| Decision Date | 2010-11-17 |
| Summary: | summary |