Cleared Traditional

TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O (K122788) - FDA 510(k) Clearance

Class I General Hospital device.

K122788 · Northstar Healthcare Holdings · General Hospital
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Jan 2013
Decision
128d
Days
Class 1
Risk

K122788 is an FDA 510(k) clearance for the TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVE.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Northstar Healthcare Holdings (Dublin 2, IE). The FDA issued a Cleared decision on January 17, 2013 after a review of 128 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 Northstar Healthcare Holdings devices

Submission Details

510(k) Number K122788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2012
Decision Date January 17, 2013
Days to Decision 128 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 129d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K122788.
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
K250069 · Comfort Rubber Gloves Industries Sdn. Bhd. · Apr 2025
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
K240266 · Sri Trang Gloves (Thailand) Public Company Limited · Sep 2024
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
K230573 · Kossan International Sdn Bhd · Jun 2023
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K223298 · Shandong Intco Medical Products Co, Ltd. · Feb 2023
Powder-Free Latex examination gloves
K222612 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Nov 2022
Non Sterile Powder Free Latex Examination Glove
K221667 · New Era Medicare Sdn. Bhd. · Oct 2022