Cleared Traditional

K211816 - Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

K211816 is an FDA 510(k) clearance for Brightway Brand, manufactured by Brightway Holdings Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 509-day FDA review.

K211816 · Brightway Holdings Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
509d
Days
Class 1
Risk

K211816 is an FDA 510(k) clearance for the Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Us.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Brightway Holdings Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on November 2, 2022 after a review of 509 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Brightway Holdings Sdn. Bhd. devices

FDA 510(k) Submission Details - K211816

510(k) Number K211816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2021
Decision Date November 02, 2022
Days to Decision 509 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
380d slower than avg
Panel avg: 129d · This submission: 509d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1149
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K211816.
Nitrile Examination Gloves
K213981 · Emerald Glove Manufacturing Sdn Bhd · Nov 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue)
K222225 · Hartalega NGC Sdn. Bhd. · Nov 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
K222898 · Safesource Direct, LLC · Nov 2022
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
K220371 · Summit Glove, Inc. · Nov 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K223320 · Lingshi Hongruida Health Protection Technology Co., Ltd. · Nov 2022
Medical Examination Gloves (Nitrile) (XS, S, M, L, XL)
K222498 · Humanwell Healthcare Group Medical Supplies Co., Ltd. · Oct 2022