The following data is part of a premarket notification filed by Ampri Rubberware Industries Sdn Bhd with the FDA for Correct Touch Examination Gloves (latex).
| Device ID | K892175 |
| 510k Number | K892175 |
| Device Name: | CORRECT TOUCH EXAMINATION GLOVES (LATEX) |
| Classification | Latex Patient Examination Glove |
| Applicant | AMPRI RUBBERWARE INDUSTRIES SDN BHD MAGNUM PLAZA, SUITE 801, 8TH 128 JALAN PUDU, 55100 KUALA Lumpur, Malaysia, MY |
| Contact | Jimmy Chiew |
| Correspondent | Jimmy Chiew AMPRI RUBBERWARE INDUSTRIES SDN BHD MAGNUM PLAZA, SUITE 801, 8TH 128 JALAN PUDU, 55100 KUALA Lumpur, Malaysia, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-05 |
| Decision Date | 1989-08-25 |