The following data is part of a premarket notification filed by Shijiazhuang Great Vision Plastic Products Co., Lt with the FDA for Synthetic Powder Free (yellow) Vinyl Patient Examination Gloves.
| Device ID | K002015 |
| 510k Number | K002015 |
| Device Name: | SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT 12390 EAST END AVE. Chino, CA 91710 |
| Contact | James Chu |
| Correspondent | James Chu SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT 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 | 2000-07-03 |
| Decision Date | 2000-08-09 |