The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Correct Touch Examination Gloves (latex).
Device ID | K892175 |
510k Number | K892175 |
Device Name: | CORRECT TOUCH EXAMINATION GLOVES (LATEX) |
Classification | Latex Patient Examination Glove |
Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD MAGNUM PLAZA, SUITE 801, 8TH 128 JALAN PUDU, 55100 KUALA Lumpur, Malaysia, MY |
Contact | Jimmy Chiew |
Correspondent | Jimmy Chiew AMPRI RUBBERWARE INDUSTRIES SDN BHD MAGNUM PLAZA, SUITE 801, 8TH 128 JALAN PUDU, 55100 KUALA Lumpur, Malaysia, MY |
Product Code | LYY |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-05 |
Decision Date | 1989-08-25 |