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
913–936 of 1181
Cleared May 31, 2002
SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES
K021000
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 64d
Cleared May 22, 2002
SMART GLOVE STERILE NITRILE EXAMINATION GLOVES (POWDERED FREE)
K021013
Smart Glove Corp. Sdn Bhd
General Hospital · 54d
Cleared May 16, 2002
SHANGHAI GLOVMAX ENTERPRISE POWDERFREE BLUE NITRILE EXAMINATION GLOVES
K021001
Shanghai Glovmax Enterprise Co.,Ltd
General Hospital · 49d
Cleared May 16, 2002
DERMAGRIP AND MULTIPLE POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NON-STERILE
K021396
Wrp Specialty Products Sdn. Bhd.
General Hospital · 14d
Cleared May 14, 2002
GLOVCO POWDER-FREE NITRILE EXAMINATION GLOVES
K021308
Glovco (M) Sdn. Bhd.
General Hospital · 19d
Cleared May 02, 2002
SYNTEX POWDER-FREE POLYMER-COATED NITRILE EXAMINATION GLOVE
K020751
Syntex Healthcare Products Co., Ltd.
General Hospital · 56d
Cleared Apr 22, 2002
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)
K020868
Seal Polymer Industries Bhd.
General Hospital · 35d
Cleared Mar 05, 2002
CHLORINATED POWDER FREE NITRILE MEDICAL EXAMINATION GLOVES WITH ALOE VERA
K013774
Supermax Sdn Bhd
General Hospital · 112d
Cleared Feb 26, 2002
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
K020493
Syntex Healthcare Products Co., Ltd.
General Hospital · 13d
Cleared Feb 15, 2002
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE AND YELLOWISH WHITE
K014284
Formosa Glove Industrial Co., Ltd.
General Hospital · 50d
Cleared Feb 14, 2002
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE, PURPLE
K014285
Formosa Glove Industrial Co., Ltd.
General Hospital · 49d
Cleared Feb 14, 2002
NON-STERILE POWDER FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE, COLOR: BLUE
K020317
Sgmp Co., Ltd.
General Hospital · 15d
Cleared Feb 13, 2002
POWDER-FREE LAVENDER/PURPLE NITRILE EXAM GLOVES
K013998
Sheen More Ent. Co., Ltd.
General Hospital · 71d
Cleared Feb 04, 2002
POLYCOAT POWDERED LATEX EXAMINATION GLOVE WITH ALOE VERA & PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K013254
Top Quality Mfg., Inc.
General Hospital · 129d
Cleared Feb 04, 2002
POWDER FREE (BLUE) NITRILE PATIENT EXAMINATION GLOVES
K014077
Shijiazhuang Great Vision Plastic Products Co., LT
General Hospital · 55d
Cleared Jan 23, 2002
CLEANTEXX POWDERFREE SYNTHETIC LATEX EXAMINATION GLOVE MADE WITH BARRIER-PRO BUTADIENE CO-POLMER
K013303
Latexx Manufacturing Sdn.Bhd.
General Hospital · 111d
Cleared Nov 29, 2001
MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
K013261
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 59d
Cleared Nov 16, 2001
SMART GLOVE STERILE NITRILE EXAM GLOVE
K012853
Smart Glove Corp. Sdn Bhd
General Hospital · 84d
Cleared Oct 19, 2001
TRUE ADVANTAGE NON-STERILE POWDER FREE PURPLE NITRILE EXAMINATION GLOVE
K013016
Tillotson Healthcare Corp.
General Hospital · 42d
Cleared Oct 01, 2001
POWDERFREE NITRILE NEOPRENE EXAMINATION GLOVES (PULPLE)
K012786
Shamrock Manufacturing Company
General Hospital · 42d
Cleared Sep 26, 2001
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961
Shen Wei (Usa), Inc.
General Hospital · 96d
Cleared Sep 21, 2001
PRE-POWDERED NITRILE EXAMINATION GLOVES
K010232
P.T. Healthcare Glovindo
General Hospital · 240d
Cleared Sep 18, 2001
GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
K012899
Best Manufacturing Company
General Hospital · 20d
Cleared Sep 17, 2001
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
K011613
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 115d