LZA · Class I · 21 CFR 880.6250

FDA Product Code LZA: Polymer Patient Examination Glove

Examination gloves are among the most used medical devices in healthcare settings. FDA product code LZA covers polymer patient examination gloves — including nitrile, vinyl, and other synthetic materials.

These gloves provide a protective barrier between healthcare workers and patients during examination and non-surgical procedures. Nitrile gloves are the preferred choice for latex-sensitive patients and clinicians.

LZA devices are Class I medical devices, regulated under 21 CFR 880.6250 and reviewed by the FDA General Hospital panel.

Leading manufacturers include Shen Wei (Usa), Inc., Hartalega Sdn Bhd and Hartalega NGC Sdn. Bhd..

1181
Total
1181
Cleared
118d
Avg days
1984
Since
1181 devices
985–1008 of 1181
Cleared Aug 11, 2000
NIPROTECT POWDER-FREE NITRILE EXAMINATION GLOVES
K994124
Mapa Professional
General Hospital · 248d
Cleared Jul 26, 2000
MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
K001497
Multisafe Sdn. Bhd.
General Hospital · 72d
Cleared Jul 26, 2000
MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)
K001619
Multisafe Sdn. Bhd.
General Hospital · 62d
Cleared Jul 26, 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
K001836
Shanghai Poseidon Plastic Products Co., Ltd.
General Hospital · 40d
Cleared Jul 25, 2000
ULTIMATE N-DEX POWER FREE NITRILE EXMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K001375
Best Manufacturing Company
General Hospital · 85d
Cleared Jul 11, 2000
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
K001837
Shanghai Poseidon Plastic Products Co., Ltd.
General Hospital · 25d
Cleared Jun 23, 2000
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, GREEN COLOR
K001637
Sheen More Ent. Co., Ltd.
General Hospital · 24d
Cleared Jun 12, 2000
MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)
K001549
Shanghai Poseidon Plastic Products Co., Ltd.
General Hospital · 25d
Cleared Jun 08, 2000
FLEXAM NITRILE T AMBI EXAMINATION GLOVES WITH CHEMO CLAIM
K000813
Allegiance Healthcare Coporation
General Hospital · 87d
Cleared May 23, 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
K001065
Sheen More Ent. Co., Ltd.
General Hospital · 50d
Cleared May 23, 2000
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
K001128
Shanghai Poseidon Plastic Products Co., Ltd.
General Hospital · 46d
Cleared May 23, 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
K001155
Sheen More Ent. Co., Ltd.
General Hospital · 43d
Cleared May 03, 2000
POWDER-FREE NITRILE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K991422
Shen Wei (Usa), Inc.
General Hospital · 376d
Cleared Apr 28, 2000
UNIGLOVE NITRILE POWDER-FREE EXAMINATION GLOVES
K000689
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 59d
Cleared Apr 20, 2000
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
K000868
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Apr 14, 2000
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
K000223
Phoenix Medical Technology, Inc.
General Hospital · 81d
Cleared Apr 12, 2000
NITRILE EXAM GLOVE, POWDER FREE, BLUE
K000670
Shasta Asia Partners Gloves Manufacturing CO , Ltd.
General Hospital · 44d
Cleared Apr 12, 2000
UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
K000688
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 43d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDER FREE, NON STERILE
K000323
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE POWDER FREE, NON STERILE
K000329
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Apr 05, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR), POWDER FREE, NON STERILE
K000330
Siam Sempermed Corp., Ltd.
General Hospital · 63d
Cleared Mar 10, 2000
NITRI-CARE NITRILE POWDER-FREE STERILE MEDICAL EXAMINATION GLOVES (BLUE, CHERRY FLAVORED)
K993805
Best Manufacturing Company
General Hospital · 122d
Cleared Mar 02, 2000
DISPOSABLE POWDER FREE NITRILE EXAM GLOVES, WHITE COLOR
K000226
Sheen More Ent. Co., Ltd.
General Hospital · 35d
Cleared Feb 07, 2000
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K993876
Shen Wei (Usa), Inc.
General Hospital · 84d