K181130 is an FDA 510(k) clearance for the Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs. This device is classified as a Medical Glove, Specialty (Class I - General Controls, product code LZC).
Submitted by Hebei Titans Hongsen Medical Technology Co., Ltd. (Nangong, CN). The FDA issued a Cleared decision on August 10, 2018, 102 days after receiving the submission on April 30, 2018.
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 | K181130 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 2018 |
| Decision Date | August 10, 2018 |
| Days to Decision | 102 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. |