K242533 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).
Submitted by Better Care Plastic Technology Co., Ltd. (Shenze County, CN). The FDA issued a Cleared decision on March 18, 2025, 204 days after receiving the submission on August 26, 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 | K242533 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2024 |
| Decision Date | March 18, 2025 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| 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. |