K242558 is an FDA 510(k) clearance for the Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid. This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).
Submitted by O&M Halyard, Inc. (Mechanicsville, US). The FDA issued a Cleared decision on December 17, 2024, 111 days after receiving the submission on August 28, 2024.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants..
| 510(k) Number | K242558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2024 |
| Decision Date | December 17, 2024 |
| Days to Decision | 111 days |
| Submission Type | Abbreviated |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZA — Polymer Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants. |