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 Central Medicare Sdn Bhd, O&M Halyard, Inc. and Jr Engineering & Medical Technologies (M) Sdn. Bhd..
79
Total
79
Cleared
157d
Avg days
1989
Since
Stable submission activity - 2 submissions in the last 2 years
Review times improving: avg
118d
recently vs 158d historically
FDA 510(k) Cleared Medical Glove, Specialty Devices (Product Code LZC)
79 devices
Cleared
Jan 14, 2026
Cardinal Health Nitrile Examination Gloves Extended Cuff
Cardinalhealth
General Hospital
173d
Cleared
Feb 24, 2025
Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
Lingshi Hongruida Health Protection Technology Co., Ltd.
General Hospital
63d
Cleared
Aug 30, 2022
JR Medic
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital
131d
Cleared
Aug 27, 2022
Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
Better Care Plastic Technology Co., Ltd.
General Hospital
12d
Cleared
May 26, 2022
Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
Hl Rubber Industries Sdn Bhd
General Hospital
90d
Cleared
May 14, 2022
Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs
Hainan Asther Medical Equipment Co., Ltd.
General Hospital
81d
Cleared
Mar 31, 2022
Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs
Niujian Technology Co., Ltd.
General Hospital
51d
Cleared
Mar 10, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs
Changzhou Universal Medical Equipment Co., Ltd.
General Hospital
85d
Cleared
Jan 28, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs
Anhui Xinyisheng Medical Technology Co.,Ltd
General Hospital
115d
Cleared
Dec 20, 2021
AspenMed+
Aspen Glove Sdn. Bhd.
General Hospital
88d
Cleared
Dec 08, 2021
Disposable Medical Nitrile Examination Gloves (Non sterile)
Jiangsu Nanfang Medical Co., Ltd.
General Hospital
110d
Cleared
Dec 06, 2021
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
General Hospital
94d
Cleared
Oct 11, 2020
Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove
0 & M Halyard, Inc.
General Hospital
215d
Cleared
Sep 18, 2020
Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs)
Medline Industires, Inc.
General Hospital
114d
Cleared
Jun 04, 2020
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate
Ever Global (Vietnam) Enterprise Corp
General Hospital
167d
Cleared
Nov 08, 2019
Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves
O&M Halyard, Inc.
General Hospital
184d
Cleared
Oct 23, 2019
Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs
Encompass Industries Sdn. Bhd.
General Hospital
307d
Cleared
Aug 29, 2019
Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
Gmp Medicare Sdn Bhd (F25)
General Hospital
363d
Cleared
Jul 04, 2019
Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim
Central Medicare Sdn Bhd
General Hospital
233d
Cleared
May 06, 2019
Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
Showa Best Glove, Inc.
General Hospital
96d
Cleared
Mar 19, 2019
Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue
Yty Industry (Manjung) Sdn Bhd
General Hospital
200d
Cleared
Feb 05, 2019
Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
O&M Halyard, Inc.
General Hospital
84d
Cleared
Aug 10, 2018
Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs
Hebei Titans Hongsen Medical Technology Co., Ltd.
General Hospital
102d
Cleared
Jul 08, 2018
PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs
Shen Wei (Usa), Inc.
General Hospital
209d
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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - LZC Product Code
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 →