Cleared Traditional

K112693 - NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES

K112693 is an FDA 510(k) clearance for NON-STERILE, manufactured by Sgmp Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K112693 · Sgmp Co., Ltd. · General Hospital
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Sep 2012
Decision
363d
Days
Class 1
Risk

K112693 is an FDA 510(k) clearance for the NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sgmp Co., Ltd. (Sparks, US). The FDA issued a Cleared decision on September 12, 2012 after a review of 363 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Sgmp Co., Ltd. devices

FDA 510(k) Submission Details - K112693

510(k) Number K112693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2011
Decision Date September 12, 2012
Days to Decision 363 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
234d slower than avg
Panel avg: 129d · This submission: 363d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

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 671
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K112693.
TEXTURED, BLUE, LATEX, POWDER FREE EXAMINATION GLVOES, WITH PROTEIN LABELING CLAIM (50UG/DM OR LESS OF WATER SOLUBLE PRO
K123026 · Northstar Healthcare Holdings · Nov 2012
COLORED POWDER FREE LATEX EXAMINATION GLOVE (WHITE AND BLUE)
K121594 · Tekmedic (M) Sdn Bhd · Oct 2012
FLAVORED POWDER FREE AND POLYMER COATED EXAMINATION GLOVE (VANLLA, GRAPE AND STRAWBERRY)
K121591 · Tekmedic (M) Sdn Bhd · Oct 2012
POWDER FREE LATEX EXAMINATION GLOVES
K113685 · Khai Hoan Joint Stock Company · Aug 2012
POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES
K120963 · Medtexx Manufacturing Sdn. Bhd. · Jun 2012
LANO-E
K111604 · Ug Global Resources Sdn. Bhd. · Jun 2012