The following data is part of a premarket notification filed by Ksg Medicare Sdn. Bhd. with the FDA for Powder Free Nitrile Examination Glove, Non-sterile, Tested For Use With Chemotherapy Drugs, And The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid (blue).
| Device ID | K220215 |
| 510k Number | K220215 |
| Device Name: | Powder Free Nitrile Examination Glove, Non-sterile, Tested For Use With Chemotherapy Drugs, And The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid (Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | KSG MEDICARE Sdn. Bhd. PTD 16063, Kawasan Perindustrian Tangkak, MY 84900 |
| Contact | Jennifer Yeo |
| Correspondent | Wava Truscott Truscott MedSci Associates, LLC 180 Burkemeade Ct. Roswell, GA 30075 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | OPJ |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-26 |
| Decision Date | 2022-03-26 |