Cleared Traditional

K892975 - LOW POWDER SINGLE USE LATEX EXAM GLOVES

K892975 is an FDA 510(k) clearance for LOW POWDER SINGLE USE LATEX EXAM GLOVES, manufactured by Phoenix Medical Technology, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K892975 · Phoenix Medical Technology, Inc. · General Hospital
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Jun 1989
Decision
68d
Days
Class 1
Risk

K892975 is an FDA 510(k) clearance for the LOW POWDER SINGLE USE LATEX EXAM GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Phoenix Medical Technology, Inc. (Andrews, US). The FDA issued a Cleared decision on June 19, 1989 after a review of 68 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 - K892975

510(k) Number K892975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1989
Decision Date June 19, 1989
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 K892975.
PATIENT EXAMIAINATION GLOVES (LATEX)
K892247 · Jiann FA Rubber Factory Co., Ltd. · Jun 1989
QUALITEX LATEX EXAMINATION GLOVES
K892414 · Agri-Bag Corp. · Jun 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892471 · Tabri Gloves Sdn. Bhd. · Jun 1989
LATEX EXAMINATION GLOVES
K893015 · Universal Gloves Private , Ltd. · Jun 1989
CHAMP-PAQ LATEX PATIENT EXAMINATION GLOVES
K893107 · Winmed Instruments Mfg. Corp. · Jun 1989
WARDEN LATEX EXAMINATION GLOVES
K893179 · Kuo Jun Ent. Co., Ltd. · Jun 1989
K892975 · LOW POWDER SINGLE USE LATEX EXAM GLOVES
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