The following data is part of a premarket notification filed by Sgmp Co., Ltd. with the FDA for Non-sterile, Latex Powder Free Patient Examination Gloves (multicolored With Xylitol And Calcium Carbonate).
| Device ID | K071060 |
| 510k Number | K071060 |
| Device Name: | NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE) |
| 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 | 2007-04-16 |
| Decision Date | 2007-07-26 |
| Summary: | summary |