The following data is part of a premarket notification filed by Sgmp Co., Ltd. with the FDA for Non-sterile Powder Free Pink Latex Examination Glove And Non-sterile Powder Free Pink Latex Examination Glove With Straw.
| Device ID | K011371 |
| 510k Number | K011371 |
| Device Name: | NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW |
| 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 | 2001-05-04 |
| Decision Date | 2001-06-07 |