The following data is part of a premarket notification filed by Sgmp Co., Ltd. with the FDA for Vital Shield Gold Powdered Latex Examination Gloves With Protein Content Labeling Claim (200 Micrograms Or Less).
| Device ID | K000390 |
| 510k Number | K000390 |
| Device Name: | VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) |
| Classification | Latex Patient Examination Glove |
| Applicant | SGMP CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Contact | Janna P Tucker |
| Correspondent | Janna P Tucker SGMP CO., LTD. 198 AVENUE DE LA D'EMERALD Sparks, NV 89434 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-04-12 |