The following data is part of a premarket notification filed by Sgmp Co., Ltd. with the FDA for Non-sterile Powder-free, Blue Nitrile Examination Gloves.
| Device ID | K000868 |
| 510k Number | K000868 |
| Device Name: | NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | SGMP CO., LTD. 181 MOO 6, TAMBOL KAMPAENGPETCH, RATTAPHUM Songkhla, TH 90180 |
| Contact | Cheah Chor Hee |
| Correspondent | Cheah Chor Hee SGMP CO., LTD. 181 MOO 6, TAMBOL KAMPAENGPETCH, RATTAPHUM Songkhla, TH 90180 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-17 |
| Decision Date | 2000-04-20 |