K222449 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue). This device is classified as a Medical Glove, Specialty (Class I - General Controls, product code LZC).
Submitted by Better Care Plastic Technology Co., Ltd. (Shenze County, CN). The FDA issued a Cleared decision on August 27, 2022, 12 days after receiving the submission on August 15, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. A Disposable Medical Glove (examination Or Surgeons) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc..
| 510(k) Number | K222449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 15, 2022 |
| Decision Date | August 27, 2022 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZC - Medical Glove, Specialty |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Disposable Medical Glove (examination Or Surgeons) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc. |