The following data is part of a premarket notification filed by Tekmedic (m) Sdn Bhd with the FDA for Powder-free Patient Examination Gloves.
| Device ID | K971949 |
| 510k Number | K971949 |
| Device Name: | POWDER-FREE PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | TEKMEDIC (M) SDN BHD 6324 MEETING HOUSE WAY Alexandria, VA 22312 -1718 |
| Contact | Kopk-kee Hon |
| Correspondent | Kopk-kee Hon TEKMEDIC (M) SDN BHD 6324 MEETING HOUSE WAY Alexandria, VA 22312 -1718 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-28 |
| Decision Date | 1997-07-28 |