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 |