The following data is part of a premarket notification filed by Pamitex Industries Sdn Bhd with the FDA for Health-plus, Sanitex, Reliance Pre-powdered Latex Examination Gloves - Blue Color.
Device ID | K000952 |
510k Number | K000952 |
Device Name: | HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR |
Classification | Latex Patient Examination Glove |
Applicant | PAMITEX INDUSTRIES SDN BHD 2 1/2 MILES, JALAN RASAH SEREMBAN, NAGERI SEMBILAN Darul Khusus, MY 70300 |
Contact | Said Awang |
Correspondent | Said Awang PAMITEX INDUSTRIES SDN BHD 2 1/2 MILES, JALAN RASAH SEREMBAN, NAGERI SEMBILAN Darul Khusus, MY 70300 |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-03-24 |
Decision Date | 2000-06-30 |