The following data is part of a premarket notification filed by Top Glove Sdn Bhd with the FDA for Sterile Nitrile Surgical Powder Free Gloves Tested For Use With Chemotherapy Drugs And Sterile Latex Surgical Powder Free Gloves.
| Device ID | K171279 |
| 510k Number | K171279 |
| Device Name: | Sterile Nitrile Surgical Powder Free Gloves Tested For Use With Chemotherapy Drugs And Sterile Latex Surgical Powder Free Gloves |
| Classification | Surgeon's Gloves |
| Applicant | Top Glove SDN BHD Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru Klang, MY 41050 |
| Contact | Noor Akilah Bt Saidin |
| Correspondent | Noor Akilah Bt Saidin Top Glove SDN BHD Lot 4968, Jalan Teratai, Batu 6, Off Jalan Meru Klang, MY 41050 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-01 |
| Decision Date | 2017-10-12 |