Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate

FDA 510(k) K221626 · Jr Engineering & Medical Technologies (M) Sdn. Bhd.

Substantially Equivalent

510(k) numberK221626

Submission

Device name
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
Applicant
Jr Engineering & Medical Technologies (M) Sdn. Bhd.
Hulu Selangor, MY
Received
June 6, 2022
Decision date
December 7, 2022
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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

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
K222350Sterile Nitrile Surgical Gloves Powder FreeKGO · Abbreviated 04/13/2023SE
K222348JR MedicLYY · Abbreviated 10/27/2022SE
K221169JR MEDIC Nitrile Examination Gloves Powder Free- BlackLZA · Abbreviated 10/25/2022SE
K222349JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)LZA · Abbreviated 10/21/2022SE
K221157JR MedicLZC · Abbreviated 08/30/2022SE
K212827Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy…LZC · Abbreviated 12/06/2021SE
K192328JR.MEDIK Latex Surgeon’s Gloves Powder FreeKGO · Abbreviated 03/10/2020SE
K192333Blue Nitrile Examination Gloves Powder FreeLZA · Abbreviated 01/24/2020SE
K192329Blue Latex Examination Powder Free GlovesLYY · Abbreviated 11/25/2019SE

Questions and answers

When was Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate cleared by the FDA?

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate (K221626) received a 510(k) decision of Substantially Equivalent on December 7, 2022, 184 days after the submission was received.

What is the product code of K221626?

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