Cleared Traditional

K000555 - TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & POWDER LABEL CLAIM CONTAINS 70MGM OR LESS O

K000555 is an FDA 510(k) clearance for TEKMEDIC POWDERED SINGLE-USE LATEX PATI..., manufactured by Tekmedic (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K000555 · Tekmedic (M) Sdn Bhd · General Hospital
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Apr 2000
Decision
54d
Days
Class 1
Risk

K000555 is an FDA 510(k) clearance for the TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN & .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Tekmedic (M) Sdn Bhd (Alexandria, US). The FDA issued a Cleared decision on April 12, 2000 after a review of 54 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.

View all Tekmedic (M) Sdn Bhd devices

FDA 510(k) Submission Details - K000555

510(k) Number K000555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2000
Decision Date April 12, 2000
Days to Decision 54 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 129d · This submission: 54d
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 618
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K000555.
POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
K000867 · Sgmp Co., Ltd. · Apr 2000
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS)
K000390 · Sgmp Co., Ltd. · Apr 2000
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K000391 · Sgmp Co., Ltd. · Apr 2000
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC (POWDERFREE)
K991677 · London International Group, Inc. · Apr 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE
K000828 · Pamitex Industries Sdn Bhd · Apr 2000
POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING
K000671 · Sgmp Co., Ltd. · Mar 2000