Powder Free Polychloroprene Examination Glove Green

FDA 510(k) K153510 · Terang Nusa Sdn Bhd

Substantially Equivalent

510(k) numberK153510

Submission

Device name
Powder Free Polychloroprene Examination Glove Green
Applicant
Terang Nusa Sdn Bhd
Kota Bharu, MY
Received
December 7, 2015
Decision date
March 21, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms…LYY · Special 05/24/2017SE
K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene…LZA · Traditional 11/28/2016SE
K151392Sensiflex Plus Sterile Latex Green Surgical Glove Powder Free with Protein Content…KGO · Traditional 09/18/2015SE
K140355Sensiflex Plus Sterile Latex Surgical Glove Powderfree with Protein Content Labeling ClaimKGO · Traditional 11/06/2014SE
K110698Nuzone X2T Chemo, Polychloroprene Synthetic Tan Surgical Gloves Powder FreeKGO · Traditional 12/07/2011SE
K102230Nugard Nitile Grey ColorLZA · Special 09/10/2010SE
K102119Sur-G Glov and MaxitexKGO · Special 08/27/2010SE
K083337Nugard, Sensiflex Procedure Examination GlovesLYY · Special 01/27/2009SE
K052837Sensiflex Plus Polymer Coated Latex Powder-Free Surgical Glove with Aloe VeraKGO · Special 11/21/2005SE
K051562Nuzone Syngard Powder Free Polymer Coated Polyisoprene Sterile Surgical Glove - Aloe…KGO · Traditional 10/20/2005SE

Questions and answers

When was Powder Free Polychloroprene Examination Glove Green cleared by the FDA?

Powder Free Polychloroprene Examination Glove Green (K153510) received a 510(k) decision of Substantially Equivalent on March 21, 2016, 105 days after the submission was received.

What is the product code of K153510?

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