Cleared Traditional

K021659 - PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)

K021659 is an FDA 510(k) clearance for PRE-POWDERED LATEX EXAMINATION GLOVES W..., manufactured by P.T. Healthcare Glovindo. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K021659 · P.T. Healthcare Glovindo · General Hospital
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Aug 2002
Decision
84d
Days
Class 1
Risk

K021659 is an FDA 510(k) clearance for the PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by P.T. Healthcare Glovindo (Medan, ID). The FDA issued a Cleared decision on August 12, 2002 after a review of 84 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 P.T. Healthcare Glovindo devices

FDA 510(k) Submission Details - K021659

510(k) Number K021659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2002
Decision Date August 12, 2002
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 817
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K021659.
POWDERED LATEX EXAM GLOVES WITH PROTEIN LABELING (200UG/G OR LESS)
K022530 · Hycare Intl. Co., Ltd. · Aug 2002
POWDER-FREE LATEX EXAMINATION GLOVE (SURFACE TREATED WITH ALOE VERA GEL)
K022601 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2002
GLOVCO EBONY
K013828 · Glovco (M) Sdn. Bhd. · Aug 2002
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS (50 MICROGRAMS OR LESS)
K021855 · Top Glove Sdn. Bhd. · Aug 2002
LATEX PRE-POWDERED EXAMINATION GLOVES WITH PROTEIN CLAIM
K020040 · Pt. Maja Agung Latexindo · Aug 2002
TOP GLOVE MEDICAL (THAILAND) POWDERED LATEX EXAMINATION GLOVES
K021950 · Top Glove Medical (Thailand) Co., Ltd. · Aug 2002