FDA Product Code LZC: Medical Glove, Specialty
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.
Leading manufacturers include Lingshi Hongruida Health Protection Technology Co., Ltd. and Cardinalhealth.
FDA 510(k) Cleared Medical Glove, Specialty Devices (Product Code LZC)
About Product Code LZC - Regulatory Context
510(k) Submission Activity
79 total 510(k) submissions under product code LZC since 1989, with 79 receiving FDA clearance (average review time: 157 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under LZC have taken an average of 118 days to reach a decision - down from 158 days historically, suggesting improved FDA processing for this classification.
LZC devices are reviewed by the General Hospital panel. Browse all General Hospital devices →