The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Correct Touch Surgeons Gloves.
Device ID | K892176 |
510k Number | K892176 |
Device Name: | CORRECT TOUCH SURGEONS GLOVES |
Classification | Surgeon's Gloves |
Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD MAGNUM PLAZA, SUITE 801, 8TH 128 JALAN PUDU, 55100 KUALA Lumpur, Malaysia, MY |
Contact | May Phng |
Correspondent | May Phng AMPRI RUBBERWARE INDUSTRIES SDN BHD MAGNUM PLAZA, SUITE 801, 8TH 128 JALAN PUDU, 55100 KUALA Lumpur, Malaysia, MY |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-05 |
Decision Date | 1989-09-06 |