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
505–528 of 1181
Cleared Sep 08, 2017
Powder Free Nitrile Examination Glove
K171667
Professional Latex Sdn Bhd
General Hospital · 95d
Cleared Aug 25, 2017
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
K170136
Shandong Feiyang Professional Gloves Co., Ltd.
General Hospital · 220d
Cleared Aug 25, 2017
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
K171104
Yty Industry (Manjung) Sdn Bhd
General Hospital · 134d
Cleared Jul 31, 2017
Xingyu Nitrile Powder Free Patient Examination Gloves, White color
K171615
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 60d
Cleared Jul 25, 2017
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
K162312
Shen Wei (Usa), Inc.
General Hospital · 341d
Cleared Jul 20, 2017
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
K171616
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 49d
Cleared Jul 19, 2017
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
K171093
Sanrea Healthcare Products Pvt, Ltd.
General Hospital · 98d
Cleared Jul 18, 2017
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
K162510
Ug Global Resources Sdn. Bhd.
General Hospital · 313d
Cleared Jul 14, 2017
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
K170686
Brightway Holdings Sdn. Bhd.
General Hospital · 129d
Cleared Jul 10, 2017
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs
K170397
Kossan International Sdn Bhd
General Hospital · 151d
Cleared Jul 07, 2017
DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
K163035
Elm Tree Medical, Inc.
General Hospital · 249d
Cleared Jul 07, 2017
EMG Blue Nitrile Examination Gloves Powder free with tested for use with chemotherapy Drugs
K171339
Eco Medi Glove Sdn. Bhd.
General Hospital · 60d
Cleared Jun 30, 2017
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (White)
K170794
Hartalega NGC Sdn. Bhd.
General Hospital · 106d
Cleared May 24, 2017
Powder Free Nitrile Exam Glove w/pH coating, White-Black color, Tested for Use with Chemo dr
K170290
Shen Wei (Usa), Inc.
General Hospital · 114d
Cleared May 22, 2017
Powder Free Nitrile Patient Examination Gloves, Blue
K163553
Hebei Titans Medical Supply Technology Group., Ltd.
General Hospital · 154d
Cleared May 09, 2017
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Black, Blue and Violet Blue)
K170393
Zibo Chengxun Automatic Device Co., Ltd.
General Hospital · 90d
Cleared Apr 21, 2017
BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES 12”, POWDER FREE, [PURPLE] TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K162294
Brightway Holdings Sdn. Bhd.
General Hospital · 249d
Cleared Mar 31, 2017
THERMOPLASTIC POLYETHYLENE EXAMINATION (TPE) GLOVE
K162626
Top Quality Glove Sdn. Bhd
General Hospital · 192d
Cleared Mar 29, 2017
Palm-Pro Chemo-Guard Nitrile Powder Free Examination Glove
K161929
Dipped Products (Thailand) Limited
General Hospital · 258d
Cleared Mar 28, 2017
Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White)
K162405
Comfort Rubber Gloves Industries Sdn. Bhd.
General Hospital · 211d
Cleared Mar 24, 2017
NITRILE EXAMINATION GLOVE
K163267
Brightway Holdings Sdn. Bhd.
General Hospital · 123d
Cleared Mar 03, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162646
Hartalega NGC Sdn. Bhd.
General Hospital · 162d
Cleared Feb 27, 2017
Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K162982
Medline Industries, Inc.
General Hospital · 124d
Cleared Feb 23, 2017
Powder Free Nitrile Examination Gloves, Black
K161099
Pt. Maja Agung Latexindo
General Hospital · 310d