Cleared Traditional

K052636 - TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW

K052636 is an FDA 510(k) clearance for TEH LOONG POWDER FREE SYNTHETIC VINYL P..., manufactured by Teh Loong Corp.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K052636 · Teh Loong Corp. · General Hospital
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Nov 2005
Decision
45d
Days
Class 1
Risk

K052636 is an FDA 510(k) clearance for the TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Teh Loong Corp. (Chicago, US). The FDA issued a Cleared decision on November 10, 2005 after a review of 45 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 - K052636

510(k) Number K052636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2005
Decision Date November 10, 2005
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 - LYZ Vinyl Patient Examination Glove

All 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K052636.
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
K052635 · Teh Loong Corp. · Dec 2005
ESTEEM STRETCHY VINYL GLOVE WITH COATING
K052568 · Cardinalhealth · Nov 2005
DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR
K052612 · Shanghai Antares Industries, Inc. · Nov 2005
TEH LOONG POWDERED SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, WHITE
K052634 · Teh Loong Corp. · Oct 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE, YELLOW)
K051924 · Shijiazhuang Manful Light Industrial Products Co., · Sep 2005
POWDERED VINYL PATIENT EXAMINATION GLOVES WHITE (NON-COLORED)
K051923 · Shijiazhuang Wonder Plastic Co., Ltd. · Aug 2005
K052636 · TEH LOONG POWDER FREE SYNTHETIC VINYL PATIENT EXAMINATION GLOVES, YELLOW
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