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
1009–1032 of 1181
Cleared Jan 31, 2000
OMNI GRACE NITRILE, BLUE, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K994246
Omnigrace , Ltd.
General Hospital · 46d
Cleared Jan 28, 2000
BLUE NITRILE EXAMINATION GLOVES - POWDER FREE
K994064
Glove Source, Inc.
General Hospital · 58d
Cleared Jan 20, 2000
PATIENT NITRILE EXAMINATION GLOVES (POWDERED)
K992675
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 163d
Cleared Dec 02, 1999
MULTI-COMFORT NITRILE EXAMINATION GLOVES, (POWDER FREE)
K993127
Glovesworld Industries Sdn. Bhd.
General Hospital · 73d
Cleared Nov 23, 1999
COMFIT POWDER FREE BLUE NITRILE EXAMINATION GLOVE, STERILE
K993313
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 50d
Cleared Nov 19, 1999
COMFIT POWDER FREE NITRILE EXAMINATION GLOVE, STERILE
K993311
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 46d
Cleared Nov 19, 1999
NIL, NITRILE EXAMINATION GLOVE - POWDERED
K993347
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 45d
Cleared Nov 19, 1999
NIL, NITRILE EXAMINATION GLOVE - POWDER FREE
K993348
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 45d
Cleared Nov 17, 1999
PATIENT NITRILE EXAMINATION GLOVES POWDER FREE CHLORINATED
K992678
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 99d
Cleared Nov 17, 1999
CASHMERE NON-STERILE POWDERED NITRILE EXAMINATION GLOVES BLUE AND GREEN
K993133
Seal Polymer Industries Bhd.
General Hospital · 58d
Cleared Nov 17, 1999
CASHMERE NON-STERILE BLUE POWDERED NITRILE EXAMINATION GLOVESBLUE AND GREEN)
K993134
Seal Polymer Industries Bhd.
General Hospital · 58d
Cleared Nov 09, 1999
OMNI GRACE NITRILE, GREEN, EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K993050
Omnigrace , Ltd.
General Hospital · 60d
Cleared Nov 05, 1999
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
K992924
Latexx Partners Bhd.
General Hospital · 67d
Cleared Nov 05, 1999
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K993247
Jda Intl., Inc.
General Hospital · 38d
Cleared Nov 05, 1999
INNOVATIVE GLOVES, NITRILE BUTADIENE RUBBER POWDER-FREE
K993325
Innovative Gloves Co;, Ltd.
General Hospital · 32d
Cleared Oct 29, 1999
TG MEDICAL POWDERED NITRILE BLUE EXAMINATION GLOVES
K992841
Tg Medical Sdn. Bhd.
General Hospital · 66d
Cleared Oct 27, 1999
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE
K992830
Safeskin Corp.
General Hospital · 65d
Cleared Oct 27, 1999
SUPERGLOVES, POWDER FREE NITRILE EXAMINATION GLOVES
K993258
Supermax Sdn Bhd
General Hospital · 28d
Cleared Oct 18, 1999
DERMAGRIP POWDER FREE NITRILE EXAMINATION GLOVE, NON STERILE
K990752
Wrp Specialty Products Sdn. Bhd.
General Hospital · 224d
Cleared Oct 15, 1999
DERMAGRIP POWDER FREE BLUE NITRILE EXAMINATION GLOVE, NON STERILE
K990750
Wrp Specialty Products Sdn. Bhd.
General Hospital · 221d
Cleared Oct 13, 1999
NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K992768
Ansell Perry
General Hospital · 57d
Cleared Oct 12, 1999
TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES
K992360
Tg Medical Sdn. Bhd.
General Hospital · 89d
Cleared Sep 27, 1999
NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE
K992558
Riverstone Resources Sdn Bhd
General Hospital · 59d
Cleared Sep 24, 1999
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
K992671
Latexx Partners Bhd.
General Hospital · 45d