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 Glove, Blue Colored Non-sterile (low Deramatitis Potential And Chemotherapy Drug.
| Device ID | K102790 |
| 510k Number | K102790 |
| Device Name: | POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG |
| Classification | Patient Examination Glove, Specialty |
| Applicant | PERUSAHAAN GETAH ASAS SDN BHD LOT 1365, BATU 17 JALAN SEMBILANG Klang, Selangor, MY 45800 |
| Contact | S F Cho |
| Correspondent | S F Cho PERUSAHAAN GETAH ASAS SDN BHD LOT 1365, BATU 17 JALAN SEMBILANG Klang, Selangor, MY 45800 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-27 |
| Decision Date | 2010-11-29 |