The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs.
| Device ID | K161422 |
| 510k Number | K161422 |
| Device Name: | DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
| Classification | Polymer Patient Examination Glove |
| Applicant | WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAW PERUSAHAAN BANDAR BARU SALAK TINGGI, Sepang, MY 43900 |
| Contact | Sarala Devi Jayaraman |
| Correspondent | Sarala Devi Jayaraman WRP ASIA PACIFIC SDN. BHD. LOT 1, JALAN 3, KAW PERUSAHAAN BANDAR BARU SALAK TINGGI, Sepang, MY 43900 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2016-10-20 |
| Summary: | summary |