Cleared Traditional

POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE

K130038 · Hl Rubber Industries Sdn Bhd · General Hospital
Feb 2013
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K130038 is an FDA 510(k) clearance for the POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Hl Rubber Industries Sdn Bhd (Kuala Pilah, Negeri Sembilan, MY). The FDA issued a Cleared decision on February 21, 2013, 45 days after receiving the submission on January 7, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K130038 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2013
Decision Date February 21, 2013
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition 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.

Similar Devices — LZA Polymer Patient Examination Glove

All 1167
Syntex Exam Gloves
K253160 · Basic Medical Technology, Inc. · Jan 2026
Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid; Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid
K252549 · Kossan International Sdn Bhd · Jan 2026
Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Patient Examination Glove, Black colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K251141 · Mercator Medical (Thailand), Ltd. · Nov 2025
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
K250861 · Hartalega NGC Sdn. Bhd. · Oct 2025
Program insite? Powder-Free, Disposable Nitrile Exam Gloves
K252075 · Program Insite, LLC · Oct 2025
Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate
K251716 · Basic Medical Technology, Inc. · Aug 2025