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
961–984 of 1181
Cleared Feb 15, 2001
NITRILE EXAMINATION GLOVES (POWERED)
K003922
Guthrie Medicare Products (Melaka) Sdn Bhd
General Hospital · 57d
Cleared Feb 09, 2001
POWDERFREE NITRILE PATIENT EXMINATION GLOVE
K003985
Guthrie Medicare Products (Melaka) Sdn Bhd
General Hospital · 45d
Cleared Feb 06, 2001
SHANGHAI CHINASTAR POWER-FREE BLUE NITRIL EXAMINATION GLOVES
K010247
Shanghai China Star Corp
General Hospital · 11d
Cleared Jan 26, 2001
POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE
K010072
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 17d
Cleared Jan 09, 2001
SHANGHAI CHINA STAR CORP POWDERED BLUE NITRILE PATIENT EXAMINATION GLOVES
K003675
Shanghai China Star Corp
General Hospital · 41d
Cleared Jan 02, 2001
POWDER-FREE NITRILE EXAM GLOVE, LAVENDER/PURPLE
K003563
Ning BO Yujiang Rubber & Plastic Co.
General Hospital · 43d
Cleared Dec 04, 2000
NITRILE PATIENT EXAMINATION GLOVE, POWDERED, NON-STERILE, (MULTIPLE COLORS)
K002391
Siam Sempermed Corp., Ltd.
General Hospital · 122d
Cleared Nov 29, 2000
NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE
K002818
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 29, 2000
NITRILE PATIENT EXAMINATION GLOVE (GREEN COLOR) POWDERED, NON STERILE
K002819
Siam Sempermed Corp., Ltd.
General Hospital · 117d
Cleared Nov 28, 2000
COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
K002064
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 144d
Cleared Nov 22, 2000
COMFIT CHEMO PLUS PLUS POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K001613
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 181d
Cleared Nov 22, 2000
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353
Medline Industries, Inc.
General Hospital · 27d
Cleared Nov 03, 2000
RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE
K003233
Riverstone Resources Sdn Bhd
General Hospital · 17d
Cleared Oct 26, 2000
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
K003232
Riverstone Resources Sdn Bhd
General Hospital · 9d
Cleared Oct 20, 2000
BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)
K994276
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Oct 20, 2000
BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)
K994281
Biopro (M) Sdn Bhd
General Hospital · 305d
Cleared Sep 13, 2000
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE
K000138
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDERED
K000139
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERED
K000143
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Sep 13, 2000
MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE
K000145
Industrial Clothings, Ltd.
General Hospital · 239d
Cleared Aug 15, 2000
NITRILE EXAM GLOVE, POWDER-FREE, COLOR BLUE
K002218
Shanghai Champion Plastic Products Co., Ltd.
General Hospital · 22d
Cleared Aug 15, 2000
NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE
K002220
Shanghai Champion Plastic Products Co., Ltd.
General Hospital · 22d
Cleared Aug 11, 2000
NITRILE EXAMINATION GLOVE, PRE-POWDERED, COLOR WHITE
K002216
Shanghai Champion Plastic Products Co., Ltd.
General Hospital · 18d
Cleared Aug 11, 2000
NITRILE EXAM GLOVE, POWDER-FREE, COLOR WHITE
K002217
Shanghai Champion Plastic Products Co., Ltd.
General Hospital · 18d