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 | K161823 |
| 510k Number | K161823 |
| 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, 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-01 |
| Decision Date | 2017-01-23 |
| Summary: | summary |