The following data is part of a premarket notification filed by Perusahaan Getah Asas Sdn Bhd with the FDA for Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-sterile.
| Device ID | K042805 |
| 510k Number | K042805 |
| Device Name: | POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE |
| Classification | Patient Examination Glove, Specialty |
| Applicant | PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT Klang, Selangor, MY 42100 |
| Contact | Kk Leong |
| Correspondent | Kk Leong PERUSAHAAN GETAH ASAS SDN BHD LOT 754, JALAN HAJI SIRAT Klang, Selangor, MY 42100 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-12 |
| Decision Date | 2004-12-16 |
| Summary: | summary |