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-dc24.
Device ID | K936062 |
510k Number | K936062 |
Device Name: | POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24 |
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 |