Cleared Traditional

K910949 - LATEX EXAM GLOVES-POWDER FREE

K910949 is an FDA 510(k) clearance for LATEX EXAM GLOVES-POWDER FREE, manufactured by Zhongmin (Fujian) Machinery & Electrical Equipment. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K910949 · Zhongmin (Fujian) Machinery & Electrical Equipment · General Hospital
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May 1991
Decision
92d
Days
Class 1
Risk

K910949 is an FDA 510(k) clearance for the LATEX EXAM GLOVES-POWDER FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Zhongmin (Fujian) Machinery & Electrical Equipment (Fuzhou, China, CN). The FDA issued a Cleared decision on May 17, 1991 after a review of 92 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 Zhongmin (Fujian) Machinery & Electrical Equipment devices

FDA 510(k) Submission Details - K910949

510(k) Number K910949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1991
Decision Date May 17, 1991
Days to Decision 92 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
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 720
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K910949.
LATEX EXAMINATION GLOVES
K914760 · Ansell, Inc. · Jan 1992
LATEX EXAMINATION GLOVES
K913409 · Top Glove Sdn. Bhd. · Sep 1991
LATEX EXAMINATION GLOVES
K912988 · La Glove (M) Sdn. Bhd. · Aug 1991
ALADAN LATEX MEDICAL GLOVE
K911774 · Aladan Corp. · May 1991
LATEX EXAMINATION GLOVES (HYPOALLERGENIC)
K911447 · Aladan Corp. · Apr 1991
LATEX PATIENT EXAMINATION GLOVES
K911081 · Medical Device Inspection Co., Inc. · Mar 1991