The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Absogel Sterile Powder-free Surgical Gloves.
Device ID | K945948 |
510k Number | K945948 |
Device Name: | ABSOGEL STERILE POWDER-FREE SURGICAL GLOVES |
Classification | Surgeon's Gloves |
Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD MIEL PHASE II 44300 BATANG KALI Selangor, MY |
Contact | May Phng |
Correspondent | May Phng AMPRI RUBBERWARE INDUSTRIES SDN BHD MIEL PHASE II 44300 BATANG KALI Selangor, MY |
Product Code | KGO |
CFR Regulation Number | 878.4460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-06 |
Decision Date | 1995-07-31 |