K896076 is an FDA 510(k) clearance for the L(3), LYSNIG LEAD LATEX RADIATION GLOVE(R). This device is classified as a Medical Glove, Specialty (Class I - General Controls, product code LZC).
Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on January 4, 1990, 77 days after receiving the submission on October 19, 1989.
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 | K896076 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 1989 |
| Decision Date | January 04, 1990 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| 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. |