Cleared Traditional

K905550 - PATIENT EXAMINATION GLOVES

K905550 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES, manufactured by Medical Device Inspection Co., Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K905550 · Medical Device Inspection Co., Inc. · General Hospital
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Dec 1990
Decision
8d
Days
Class 1
Risk

K905550 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on December 19, 1990 after a review of 8 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K905550

510(k) Number K905550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1990
Decision Date December 19, 1990
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 129d · This submission: 8d
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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K905550.
HIGH RISK
K903559 · Medical Resources, Ltd. · Dec 1990
PATIENT EXAM GLOVES(MFG: LIAONING MACHINERY)
K905585 · Pioneer Trading Co. · Dec 1990
ZOETIC GLOVES
K905515 · Janco Polymers Pvt., Ltd. · Dec 1990
LATEX EXAMINATION GLOVES
K902796 · Ek Hong Rubber Industry (Thailand) Co., Ltd. · Dec 1990
HYPOALLERGENIC CRANBERRY/MALAYTEX LATEX EXAM GLOVE
K904526 · Malaytex USA, Inc. · Nov 1990
SLIMFLEX, PATIENT EXAMINATION GLOVES
K905033 · Slim River Latex Sdn. Bhd. · Nov 1990
K905550 · PATIENT EXAMINATION GLOVES
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