The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Absogel Chemotheraphy Gloves.
| Device ID | K990677 |
| 510k Number | K990677 |
| Device Name: | ABSOGEL CHEMOTHERAPHY GLOVES |
| Classification | Patient Examination Glove, Specialty |
| Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor, MY 44300 |
| Contact | Li Kim Phng |
| Correspondent | Li Kim Phng AMPRI RUBBERWARE INDUSTRIES SDN BHD LOT B5 & B6, PHASE II, KAWASAN PERINDUSTRIAN MIEL Batang Kali, Selangor, MY 44300 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-02 |
| Decision Date | 1999-11-01 |