The following data is part of a premarket notification filed by Multisafe Sdn Bhd with the FDA for Powder Free Polymer Coated Latex Medical Examination Gloves, Non-sterile W/ Protein Content Labeling Claim 50 Mcg Or Les.
Device ID | K011293 |
510k Number | K011293 |
Device Name: | POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES |
Classification | Latex Patient Examination Glove |
Applicant | MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE 35500 Bidor, Perak, MY 35500 |
Contact | Abd Hadi Bin Husin |
Correspondent | Abd Hadi Bin Husin MULTISAFE SDN BHD LOT 764 BIDOR INDUSTRIAL ESTATE 35500 Bidor, Perak, MY 35500 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-30 |
Decision Date | 2001-07-10 |