The following data is part of a premarket notification filed by Sgmp Co., Ltd. with the FDA for Non-sterile Powder Free Latex Examination Gloves With Vanilla And Protein Content Labeling Claim (50 Micrograms Or Less).
| Device ID | K012863 |
| 510k Number | K012863 |
| Device Name: | NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) |
| Classification | Latex 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 | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-24 |
| Decision Date | 2001-09-21 |
| Summary: | summary |