The following data is part of a premarket notification filed by Perusahaan Getah Asas Sdn Bhd with the FDA for Powder-free Nitrile Patient Chemotherapy Examination Glove, Blue Colored.
| Device ID | K032374 |
| 510k Number | K032374 |
| Device Name: | POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED |
| Classification | Patient Examination Glove, Specialty |
| Applicant | PERUSAHAAN GETAH ASAS SDN BHD 1301 DEFENSE HIGHWAY Gambrills, MD 21054 -1928 |
| Contact | James F Logan |
| Correspondent | James F Logan PERUSAHAAN GETAH ASAS SDN BHD 1301 DEFENSE HIGHWAY Gambrills, MD 21054 -1928 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-01 |
| Decision Date | 2003-10-22 |