The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Absogel Non-sterile Examination Gloves (powder-free).
| Device ID | K946056 |
| 510k Number | K946056 |
| Device Name: | ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE) |
| Classification | Latex Patient Examination Glove |
| Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT 10, UNIT TYPE A, KAWASAN MIEL PHASE II 4300 BATANG KALI Selangor, MY |
| Contact | May Phng |
| Correspondent | May Phng AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT 10, UNIT TYPE A, KAWASAN MIEL PHASE II 4300 BATANG KALI Selangor, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-06 |
| Decision Date | 1995-07-20 |