The following data is part of a premarket notification filed by Kimberly Clark Corporation with the FDA for Kimtech Prizm Multi-layered Exam Glove Tested For Use With Chemotherapy Drugs, The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid, Kimtech Prizm Xtra Multi-layered Exam Glove Tested For Use With Chemotherapy Drugs, The .
| Device ID | K202416 |
| 510k Number | K202416 |
| Device Name: | Kimtech Prizm Multi-Layered Exam Glove Tested For Use With Chemotherapy Drugs, The Opioid Fentanyl Citrate, Simulated Gastric Acid, And Fentanyl In Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested For Use With Chemotherapy Drugs, The |
| 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 | 2020-08-24 |
| Decision Date | 2020-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036000519546 | K202416 | 000 |
| 10036000519416 | K202416 | 000 |
| 10036000519423 | K202416 | 000 |
| 10036000519430 | K202416 | 000 |
| 10036000519447 | K202416 | 000 |
| 10036000519508 | K202416 | 000 |
| 10036000519515 | K202416 | 000 |
| 10036000519522 | K202416 | 000 |
| 10036000519539 | K202416 | 000 |
| 10036000519409 | K202416 | 000 |