The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn Bhd with the FDA for Powder Free Nitrile Surgical Glove, Sterile, Tested For Use With Chemotherapy Drugs.
| Device ID | K203030 |
| 510k Number | K203030 |
| Device Name: | POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
| Classification | Surgeon's Gloves |
| Applicant | WRP ASIA PACIFIC SDN BHD Lot 1 Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, MY 43900 |
| Contact | Saravanan Ramasamy |
| Correspondent | Saravanan Ramasamy WRP USA INC Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, Selangor Darul Ehsan, MY 43900 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-02 |
| Decision Date | 2021-06-11 |