The following data is part of a premarket notification filed by Tekmedic (m) Sdn Bhd with the FDA for Colored Powder Free And Polymer Coated Examination Glove (blue, Black And Pink) With A Protein Claim Of Less Than.
| Device ID | K100694 |
| 510k Number | K100694 |
| Device Name: | COLORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (BLUE, BLACK AND PINK) WITH A PROTEIN CLAIM OF LESS THAN |
| Classification | Latex Patient Examination Glove |
| Applicant | TEKMEDIC (M) SDN BHD PLOT 4, TANJUNG KLING INDUSTRIAL AREA, TANJUNG BRUAS Jetty, Tanjung Kling, Melaka, MY 76400 |
| Contact | Patrick Leong |
| Correspondent | Patrick Leong TEKMEDIC (M) SDN BHD PLOT 4, TANJUNG KLING INDUSTRIAL AREA, TANJUNG BRUAS Jetty, Tanjung Kling, Melaka, MY 76400 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-11 |
| Decision Date | 2010-06-25 |