The following data is part of a premarket notification filed by Supermax Glove Manufacturing Sdn Bhd with the FDA for Aurelia Chlorinated Powder Free Latex Medical Examination Gloves With Aloe Vera And Ginseng With Protein Labeling Claim.
Device ID | K013953 |
510k Number | K013953 |
Device Name: | AURELIA CHLORINATED POWDER FREE LATEX MEDICAL EXAMINATION GLOVES WITH ALOE VERA AND GINSENG WITH PROTEIN LABELING CLAIM |
Classification | Latex Patient Examination Glove |
Applicant | SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor, MY 47000 |
Contact | Stanley Thai |
Correspondent | Stanley Thai SUPERMAX GLOVE MANUFACTURING SDN BHD LOT 42, PUTRA INDUSTRIAL PARK BUKIT RAHMAN PUTRA Sungai Buloh, Selangor, MY 47000 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-11-30 |
Decision Date | 2002-02-26 |