The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Ampri.
| Device ID | K952833 |
| 510k Number | K952833 |
| Device Name: | AMPRI |
| Classification | Latex Patient Examination Glove |
| Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD UNIT TYPE A, LOT 10 KAWASAN MIKEL, BATANG KALI, Phase Ii 44300 Batang Kali, MY |
| Contact | Mike Scolari |
| Correspondent | Mike Scolari AMPRI RUBBERWARE INDUSTRIES SDN BHD UNIT TYPE A, LOT 10 KAWASAN MIKEL, BATANG KALI, Phase Ii 44300 Batang Kali, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-20 |
| Decision Date | 1995-09-05 |