The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Powder Free Latex Exam Gloves W/polysil-dc929.
| Device ID | K936063 |
| 510k Number | K936063 |
| Device Name: | POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929 |
| Classification | Latex Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD HOUSE OF REPRESENTATIVES 125 CANNON BUILDING Washington, DC 20515 |
| Contact | Howard Winkler |
| Correspondent | Howard Winkler HARTALEGA SDN BHD HOUSE OF REPRESENTATIVES 125 CANNON BUILDING Washington, DC 20515 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-20 |
| Decision Date | 1994-06-06 |