Cleared Traditional

SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) (K171367) - FDA 510(k) Clearance

Class I General Hospital device.

K171367 · Sanrea Healthcare Products Pvt, Ltd. · General Hospital
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Jan 2018
Decision
262d
Days
Class 1
Risk

K171367 is an FDA 510(k) clearance for the SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LA.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sanrea Healthcare Products Pvt, Ltd. (Palakkad, IN). The FDA issued a Cleared decision on January 26, 2018 after a review of 262 days - an extended review 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: 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 Sanrea Healthcare Products Pvt, Ltd. devices

Submission Details

510(k) Number K171367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date January 26, 2018
Days to Decision 262 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
133d slower than avg
Panel avg: 129d · This submission: 262d
Pathway characteristics
Predicate-based equivalence.

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 42
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K171367.
Palm Care Latex Examination Powder Free Gloves
K202377 · Hi-Care Thai Gloves Co. , Ltd. · Dec 2020
Blue Latex Examination Powder Free Gloves
K192329 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Nov 2019
POWDER FREE LATEX EXAMINATION GLOVE
K173053 · Professional Latex Sdn Bhd · Jun 2018
EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM
K103602 · Medline Industries, Inc. · Apr 2011
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE
K012815 · Kimberly-Clark Corp. · Nov 2001
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K003055 · Medline Industries, Inc. · Jan 2001