K192104 is an FDA 510(k) clearance for the Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs). This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).
Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on December 23, 2019, 140 days after receiving the submission on August 5, 2019.
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 | K192104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2019 |
| Decision Date | December 23, 2019 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| 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. |