The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn Bhd with the FDA for Powder Free Black Nitrile Examination Gloves, Non-sterile, Tested For Use With Chemotherapy Drugs And Fentanyl Resistant.
| Device ID | K210330 |
| 510k Number | K210330 |
| Device Name: | Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl Resistant |
| 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 | Zahari Bin Darus |
| Correspondent | Saravanan Ramasamy WRP USA INC 3700 Massillon Road, Suite 340, Uniontown, Ohio Uniontown, OH 44685 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-04 |
| Decision Date | 2022-03-04 |