The following data is part of a premarket notification filed by Tekmedic (m) Sdn Bhd with the FDA for Latex Examination Gloves, Powder Free.
| Device ID | K930602 |
| 510k Number | K930602 |
| Device Name: | LATEX EXAMINATION GLOVES, POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | TEKMEDIC (M) SDN BHD C/O CAL-AMERICAN MEDICAL SUPPL 2651 MANHATTAN BEACH BOULEVARD Redondo Beach, CA 90278 |
| Contact | Wallace Wong |
| Correspondent | Wallace Wong TEKMEDIC (M) SDN BHD C/O CAL-AMERICAN MEDICAL SUPPL 2651 MANHATTAN BEACH BOULEVARD Redondo Beach, CA 90278 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-02 |
| Decision Date | 1993-09-29 |