Cleared Traditional

K232538 - DUAL COLOR NITRILE EXAMINATION GLOVES

K232538 is the FDA 510(k) clearance for DUAL COLOR NITRILE EXAMINATION GLOVES by Wrp Asia Pacific Sdn. Bhd.. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K232538 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 2023
Decision
87d
Days
Class 1
Risk

K232538 is an FDA 510(k) clearance for the DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR U.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on November 17, 2023 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wrp Asia Pacific Sdn. Bhd. devices

Submission Details

510(k) Number K232538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2023
Decision Date November 17, 2023
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 583
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K232538.
Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K233042 · Shandong Intco Medical Products Co, Ltd. · Dec 2023
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange)
K232252 · Dehai (Shandong) Medical Gloves, Co., Ltd. · Nov 2023
Medical Nitrile Examination Gloves
K232576 · Jiangsu Complete Sincerity Medical New Materials Co., Ltd. · Nov 2023
Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K232461 · Kossan International Sdn Bhd · Nov 2023
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K232266 · Better Care Plastic Technology Co., Ltd. · Nov 2023
Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl
K231029 · Zhonghong Pulin Medical Products Co., Ltd. · Oct 2023