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 |