POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).

FDA 510(k) K142862 · Careplus (M) Sdn Bhd

Substantially Equivalent

510(k) numberK142862

Submission

Device name
POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored).
Applicant
Careplus (M) Sdn Bhd
Negeri Sembilan Darul Khusus, MY
Received
October 1, 2014
Decision date
January 16, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LZA – Polymer Patient Examination Glove
Device class
Class I (low risk)
Regulation
21 CFR 880.6250
Specialty
General Hospital

A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Other 510(k)s with product code LZA

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K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder…LZA · Special Top Glove Sdn. Bhd.09/09/2026SE
K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and…LZA · Traditional Maxter Healthcare, Inc.09/09/2026SE
K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs…LZA · Special Gmp Medicare Sdn. Bhd.09/08/2026SE
K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT…LZA · Traditional Kossan International Sdn Bhd08/18/2026SE
K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile…LZA · Special O&M Halyard, Inc.07/21/2026SE
K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua…LZA · Special Hartalega NGC Sdn. Bhd.07/20/2026SE
K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with…LZA · Special Sw Technologies, Inc.06/24/2026SE
K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackLZA · Traditional Kanglongda Vietnam Protection Technology Company…06/18/2026SE
K260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and…LZA · Special Hartalega NGC Sdn. Bhd.06/17/2026SE
K260806Nitrile Disposable Examination GlovesLZA · Traditional Vista Industries,, LLC06/03/2026SE

More from Vista Industries,, LLC

510(k)DeviceDecision
K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)KGO · Traditional 10/06/2021SE
K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or…LYY · Traditional 08/20/2021SE
K201857Powder Free Nitrile Examination Glove Black and Dual Color White-BlueLZA · Traditional 08/20/2021SE
K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling…KGO · Traditional 08/03/2021SE
K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling…KGO · Traditional 06/24/2021SE
K202765ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim…KGO · Traditional 05/27/2021SE
K162858Nitrilecare Nitrile Examination Gloves Powder Free, Blue, ChemotestLZC · Traditional 07/24/2017SE
K152593Latex Examination Glove Powder FreeLYY · Traditional 02/25/2016SE
K142858POWDER FREE NITRILE EXAMINATION GLOVE, WHITE (colored)LZA · Traditional 02/09/2015SE

Questions and answers

When was POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). cleared by the FDA?

POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). (K142862) received a 510(k) decision of Substantially Equivalent on January 16, 2015, 107 days after the submission was received.

What is the product code of K142862?

The FDA product code is LZA – Polymer Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.