The following data is part of a premarket notification filed by Wrp Asia Pacific Sdn. Bhd. with the FDA for Polyisoprene Surgical Glove, Powder Free, Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl Resistant.
| Device ID | K222058 |
| 510k Number | K222058 |
| Device Name: | Polyisoprene Surgical Glove, Powder Free, Sterile, Tested For Use With Chemotherapy Drugs And Fentanyl Resistant |
| Classification | Surgeon's Gloves |
| Applicant | WRP Asia Pacific SDN. BHD. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi Sepang, MY 43900 |
| Contact | Siti Iylia Zarith Bt Hasan |
| Correspondent | Michael Scaglione WRP USA Inc 3700 Massillon Road Suite 340 Uniontown, OH 44685 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-12 |
| Decision Date | 2022-10-22 |