The following data is part of a premarket notification filed by Tekmedic (m) Sdn Bhd with the FDA for Tekmedic Powdered Single-use Latex Patient Examination Gloves With Protein & Powder Label Claim Contains 70mgm Or Less O.
| Device ID | K000555 |
| 510k Number | K000555 |
| Device Name: | TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O |
| Classification | Latex Patient Examination Glove |
| Applicant | TEKMEDIC (M) SDN BHD 6324 MEETING HOUSE WAY Alexandria, VA 22312 -1718 |
| Contact | Kok-kee Hon |
| Correspondent | Kok-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 | 2000-02-18 |
| Decision Date | 2000-04-12 |