The following data is part of a premarket notification filed by Sgmp Co., Ltd. with the FDA for Powder Free Latex Examination Gloves, Peppermint Scented (contains 50 Mcgm Or Less Of Total Water Extractable Protein Gr.
| Device ID | K000867 |
| 510k Number | K000867 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR |
| Classification | Latex 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 | LYY |
| 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 | 2000-04-21 |