Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)

FDA 510(k) K230314 · New Era Medicare Sdn. Bhd.

Substantially Equivalent

510(k) numberK230314

Submission

Device name
Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors)
Applicant
New Era Medicare Sdn. Bhd.
Teluk Intan, MY
Received
February 6, 2023
Decision date
August 16, 2023
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

510(k)DeviceApplicantDecision
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
K221424Sterile Surgical Powder Free Latex GloveKGO · Traditional 01/26/2023SE
K221667Non Sterile Powder Free Latex Examination GloveLYY · Traditional 10/28/2022SE

Questions and answers

When was Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) cleared by the FDA?

Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) (K230314) received a 510(k) decision of Substantially Equivalent on August 16, 2023, 191 days after the submission was received.

What is the product code of K230314?

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