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
1153–1176 of 1181
Cleared Jul 03, 1997
SMART - FIT, PREPOWDERED NITRILE EXAMINATION GLOVES
K971666
Sj Medical Products (M) Sdn Bhd
General Hospital · 58d
Cleared Jun 27, 1997
SMART - FIT, POWDERFREE NITRILE EXAMINATION GLOVES
K971665
Sj Medical Products (M) Sdn Bhd
General Hospital · 52d
Cleared Jun 24, 1997
ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES
K970015
Eci Medical Technologies, Inc.
General Hospital · 173d
Cleared Apr 22, 1997
NITRA-TOUCH POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K965095
Ansell Edmont Industrial, Inc.
General Hospital · 124d
Cleared Feb 10, 1997
PATIENT EXAMINATION GLOVES : NITRILE EXAMINATION GLOVES
K963804
Hartalega Sdn Bhd
General Hospital · 140d
Cleared Feb 10, 1997
NITRILE POWDER-FREE EXAMINATION GLOVES
K964628
Shen Wei (Usa), Inc.
General Hospital · 83d
Cleared Feb 07, 1997
PATIENT EXAMINATION GLOVES
K964148
Hartalega Sdn Bhd
General Hospital · 114d
Cleared Dec 19, 1996
SAFESKIN
K962139
Safeskin Corp.
General Hospital · 199d
Cleared Dec 19, 1996
NITRILE COPOLYMER PATIENT EXAMINATION GLOVES
K962518
P.T. Irama Dinamika Latex
General Hospital · 175d
Cleared Dec 19, 1996
CHLOROPRENE EXAM GLOVES
K963771
P.T. Irama Dinamika Latex
General Hospital · 91d
Cleared Aug 14, 1996
NITRILE POWDER-FREE PATIENT EXAMINATION GLOVES
K962461
Shen Wei (Usa), Inc.
General Hospital · 50d
Cleared Apr 25, 1996
TACTYLON POWDER FREE EXAMINATION GLOVE
K955464
Tactyl Technologies, Inc.
General Hospital · 147d
Cleared Dec 21, 1995
PURE ADVANTAGE POWDER FREE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES
K954573
Tillotson Healthcare Corp.
General Hospital · 80d
Cleared Dec 21, 1995
PURE ADVANTAGE NITRILE HYPOALLERGENIC PATIENT EXAMINATION GLOVES
K954574
Tillotson Healthcare Corp.
General Hospital · 80d
Cleared Dec 15, 1995
SCINITREX (POWDER FREE GREEN NITRILE EXAMINATION GLOVES
K951938
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 234d
Cleared Dec 15, 1995
SCINITREX (POWDER FREE NITRILE EXAMINATION GLOVES)
K952051
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 228d
Cleared Dec 15, 1995
SCINITREX POWER FREE BLUE NITRILE EXAMINATION GLOVES
K952154
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 221d
Cleared Dec 11, 1995
SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES
K952155
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 217d
Cleared Dec 11, 1995
ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES
K954533
Eci Medical Technologies, Inc.
General Hospital · 73d
Cleared Oct 30, 1995
SCINITREX (GREEN POWDERED NITRILE EXAMINATION GLOVES)
K951921
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 189d
Cleared Oct 30, 1995
SCINITREX (POWDERED NITRILE EXAMINATION GLOVESD)
K952052
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 182d
Cleared Apr 04, 1995
POLYDERM
K950033
Wilshire Technologies
General Hospital · 90d
Cleared Feb 14, 1995
ELASTYREN(R) PATIENT EXAMINATION GLOVES
K946291
Eci Medical Technologies, Inc.
General Hospital · 49d
Cleared Mar 09, 1990
PATIENT EXAMINATION GLOVES
K893606
Aukland Mfg., Inc.
General Hospital · 303d