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
937–960 of 1181
Cleared Aug 16, 2001
SUNMAX BLUE NITRILE POWDER-FREE EXAMINATION GLOVE
K011765
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 70d
Cleared Aug 16, 2001
POWDER FREE NEOPRENE EXAMINATION GLOVES, NON STERILE
K012048
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 48d
Cleared Aug 14, 2001
SUNMAX BLUE NITRILE POWDERED EXAMINATION GLOVES
K011717
Sunmax Enterprise Shanghai Co. , Ltd.
General Hospital · 71d
Cleared Aug 01, 2001
POWDER FREE NITRILE EXAMINATION GLOVES, VIOLET COLOR
K011791
Latexx Partners Bhd.
General Hospital · 54d
Cleared Aug 01, 2001
NON-CHLORINATED, POLYMER COATED POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K011792
Latexx Partners Bhd.
General Hospital · 54d
Cleared Aug 01, 2001
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BROWN)
K012166
Best Manufacturing Company
General Hospital · 21d
Cleared Jul 10, 2001
CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K011497
Tillotson Healthcare Corp.
General Hospital · 56d
Cleared Jul 10, 2001
POWDERED BLUE NITRILE EXAMINATION GLOVES
K011924
Seltom Pacific Sdn. Bhd.
General Hospital · 20d
Cleared Jul 09, 2001
DERMASAFE CHEMO PLUS POWDER FREE NEOPRENE EXAMINATION GLOVE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K011482
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 56d
Cleared Jul 05, 2001
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713
Kimberly-Clark Corp.
General Hospital · 31d
Cleared Jun 22, 2001
POWDER FREE NITRILE EXAMINATION GLOVES
K010233
P.T. Healthcare Glovindo
General Hospital · 149d
Cleared Jun 21, 2001
MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE
K011593
Ansell Healthcare Products, Inc.
General Hospital · 28d
Cleared May 17, 2001
SENICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL EXAMINATION GLOVE, SENSICARE ADVANTIX POWDER FREE POLYURETHANE DENTAL
K011198
Maxxim Medical, Inc.
General Hospital · 28d
Cleared May 16, 2001
POWDER-FREE NITRILE EXAM GLOVE, BLUE
K011286
Ningbo Yujiang Plastic & Rubber Co. , Ltd.
General Hospital · 19d
Cleared May 03, 2001
LAGLOVE BRAND NITROPRENE POWDER FREE EXAMINATION GLOVES (MADE OF NITRILE-NEOPRENE CO-POLYMER)
K010863
La Glove (M) Sdn. Bhd.
General Hospital · 42d
Cleared May 01, 2001
POWDER FREE NITRILE EXAMINATION GLOVE
K011012
Contract Latex Dippers Sdn Bhd
General Hospital · 27d
Cleared Apr 10, 2001
POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
K010486
Pt. Medisafe Technologies
General Hospital · 49d
Cleared Apr 10, 2001
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR
K010719
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 29d
Cleared Apr 03, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
K010110
Shen Wei (Usa), Inc.
General Hospital · 81d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (GREEN/PURPLE)
K010860
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Apr 03, 2001
LAGLOVE BRAND COLORED POWDERED NITRILE EXAMINATION GLOVES(GREEN/PURPLE)
K010861
La Glove (M) Sdn. Bhd.
General Hospital · 12d
Cleared Mar 30, 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K010097
Shen Wei (Usa), Inc.
General Hospital · 78d
Cleared Feb 28, 2001
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES
K010077
Pwa Industries Sdn. Bhd.
General Hospital · 49d
Cleared Feb 16, 2001
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
K010297
Maxxim Medical
General Hospital · 16d