Cleared Traditional

K192635 - Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange)

K192635 is an FDA 510(k) clearance for Powder Free Nitrile Patient Examination..., manufactured by Wrp Asia Pacific Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K192635 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
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Jan 2020
Decision
116d
Days
Class 1
Risk

K192635 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange). 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 January 17, 2020 after a review of 116 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Wrp Asia Pacific Sdn. Bhd. devices

FDA 510(k) Submission Details - K192635

510(k) Number K192635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2019
Decision Date January 17, 2020
Days to Decision 116 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
13d faster than avg
Panel avg: 129d · This submission: 116d
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 1013
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K192635.
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs)
K191753 · Medline Industries, Inc. · Mar 2020
Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K192241 · O&M Haylard, Inc. · Mar 2020
Blue Nitrile Examination Gloves Powder Free
K192333 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Jan 2020
Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs)
K192315 · Medline Industries, Inc. · Jan 2020
Disposable Powder Free Nitrile Examination Glove, Pink/Black Color
K190942 · Ever Growth (Vietnam) Co. , Ltd. · Jan 2020
mCare® Powder Free Nitrile Black Examination Glove
K192444 · Mercator Medical (Thailand), Ltd. · Dec 2019