Cleared Traditional

K211816 - Brightway Brand

K211816 is the FDA 510(k) clearance for Brightway Brand by Brightway Holdings Sdn. Bhd.. It is a Class 1 General Hospital device (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

Submission Details

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.

Device Classification

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 612
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