The following data is part of a premarket notification filed by Sgmp Co., Ltd. with the FDA for Non-sterile Powder Free Green Barrier-pro Synthetic Butadiene Copolymer Examination Glove, Color: Blue.
| Device ID | K020317 |
| 510k Number | K020317 |
| Device Name: | NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE |
| Classification | Polymer Patient Examination Glove |
| Applicant | SGMP CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Contact | Janna Tucker |
| Correspondent | Janna Tucker SGMP CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-30 |
| Decision Date | 2002-02-14 |
| Summary: | summary |