The following data is part of a premarket notification filed by Kimberly-clark Corporation with the FDA for Kimtech Purple Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs, The Opioid Fentanyl, Gastric Acid, And Fentanyl In Gastric Acid.
| Device ID | K200072 |
| 510k Number | K200072 |
| Device Name: | KIMTECH Purple Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs, The Opioid Fentanyl, Gastric Acid, And Fentanyl In Gastric Acid |
| Classification | Polymer Patient Examination Glove |
| Applicant | Kimberly-Clark Corporation 1400 Holcomb Bridge Road Roswell, GA 30076 |
| Contact | Juan Marquez |
| Correspondent | Wava Truscott Truscott MedSci Associates, LLC 180 Burkemeade Ct Roswell, GA 30075 |
| Product Code | LZA |
| Subsequent Product Code | LZC |
| Subsequent Product Code | QDO |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-14 |
| Decision Date | 2020-04-10 |