Cleared Traditional

Nitrile Patient Examination Powder Free Glove, Textured, Black (K161085) - FDA 510(k) Clearance

Class I General Hospital device.

K161085 · Multisafe Sdn. Bhd. · General Hospital
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Jul 2018
Decision
808d
Days
Class 1
Risk

K161085 is an FDA 510(k) clearance for the Nitrile Patient Examination Powder Free Glove, Textured, Black. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Multisafe Sdn. Bhd. (Bidor, MY). The FDA issued a Cleared decision on July 5, 2018 after a review of 808 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 Multisafe Sdn. Bhd. devices

Submission Details

510(k) Number K161085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2016
Decision Date July 05, 2018
Days to Decision 808 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
679d slower than avg
Panel avg: 129d · This submission: 808d
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 496
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K161085.
Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims
K181066 · Eco Medi Glove Sdn. Bhd. · Sep 2018
Biodegradable Nitrile Powder Free Examination Glove (Blue)
K173509 · Hartalega Sdn Bhd · Aug 2018
Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green
K180644 · Hartalega Sdn Bhd · Aug 2018
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White)
K180505 · Hartalega Sdn Bhd · Jun 2018
White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
K180452 · Riverstone Resources Sdn Bhd · Jun 2018
Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
K171422 · Ever Global (Vietnam) Enterprise Corp · Jun 2018