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
1033–1056 of 1181
Cleared Sep 24, 1999
DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR
K992686
Sheen More Ent. Co., Ltd.
General Hospital · 45d
Cleared Sep 10, 1999
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
K992210
Safeskin Corp.
General Hospital · 71d
Cleared Sep 10, 1999
BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
K992588
Formosa Glove Industrial Co., Ltd.
General Hospital · 39d
Cleared Sep 07, 1999
N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K992170
Best Manufacturing Company
General Hospital · 71d
Cleared Aug 30, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE
K992223
Pamitex Industries Sdn Bhd
General Hospital · 60d
Cleared Aug 25, 1999
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
K992062
Safeskin Corp.
General Hospital · 68d
Cleared Aug 25, 1999
POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992496
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 30d
Cleared Aug 25, 1999
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992497
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 30d
Cleared Aug 23, 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
K992299
Pamitex Industries Sdn Bhd
General Hospital · 46d
Cleared Aug 11, 1999
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
K991776
Seltom Pacific Sdn. Bhd.
General Hospital · 78d
Cleared Aug 11, 1999
NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)
K991779
Seltom Pacific Sdn. Bhd.
General Hospital · 78d
Cleared Aug 10, 1999
LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
K990883
La Glove (M) Sdn. Bhd.
General Hospital · 147d
Cleared Aug 05, 1999
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
K991845
Omnigrace , Ltd.
General Hospital · 69d
Cleared Aug 05, 1999
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
K991846
Omnigrace , Ltd.
General Hospital · 69d
Cleared Aug 05, 1999
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
K991981
Alliance Rubber Products Sdn. Bhd.
General Hospital · 52d
Cleared Jul 30, 1999
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE
K991615
Maxxim Medical
General Hospital · 81d
Cleared Jul 29, 1999
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
K992177
Pt. Berlian Glovindo
General Hospital · 31d
Cleared Jul 01, 1999
NITRILE EXAMINATION GLOVE, POWDERED, BLUE
K991821
Ning BO Yujiang Rubber & Plastic Co.
General Hospital · 35d
Cleared Jun 23, 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
K990876
Brightway Holdings Sdn. Bhd.
General Hospital · 99d
Cleared Jun 23, 1999
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K991304
M.R.G. Industries Sdn. Bhd.
General Hospital · 68d
Cleared Jun 23, 1999
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT
K991744
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 33d
Cleared Jun 21, 1999
SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K990186
Shanghai Intco. Plastic & Rubber Products Co., Ltd.
General Hospital · 152d
Cleared Jun 03, 1999
POWDER FREE BLUE NITRILE GLOVE
K990668
Tg Medical Sdn. Bhd.
General Hospital · 93d
Cleared Jun 03, 1999
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 34d