Cleared Traditional

K010875 - HYCARE LATEX EXAMINATION GLOVE, POWDERED

K010875 is an FDA 510(k) clearance for HYCARE LATEX EXAMINATION GLOVE, manufactured by Hycare Intl. Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K010875 · Hycare Intl. Co., Ltd. · General Hospital
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Jun 2001
Decision
76d
Days
Class 1
Risk

K010875 is an FDA 510(k) clearance for the HYCARE LATEX EXAMINATION GLOVE, POWDERED. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Hycare Intl. Co., Ltd. (Deerfield Beach, US). The FDA issued a Cleared decision on June 7, 2001 after a review of 76 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 - K010875

510(k) Number K010875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2001
Decision Date June 07, 2001
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 K010875.
POWDERED LATEX EXAMINATION GLOVES
K011922 · Seltom Pacific Sdn. Bhd. · Jul 2001
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES, (BLUE, GREEN)
K010854 · Protection Gloves Sdn. Bhd. · Jun 2001
CHLORINATED POWDERED LATEX EXAMINATION GLOVES, BLUE, GREEN
K011231 · Protection Gloves Sdn. Bhd. · Jun 2001
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH AND WITHOUT GRAPE SCENT AND WITH PROTEIN LABELING (50 MICROG
K011370 · Sgmp Co., Ltd. · Jun 2001
NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE AND NON-STERILE POWDER FREE PINK LATEX EXAMINATION GLOVE WITH STRAW
K011371 · Sgmp Co., Ltd. · Jun 2001
NON-STERILE POWDER-FREE BLUE LATEX EXAMINATION GLOVES, WITH AND WITHOUT BUBBLEGUM SCENTING & A PROTEIN LABELING CLAIM (5
K011377 · Sgmp Co., Ltd. · Jun 2001
K010875 · HYCARE LATEX EXAMINATION GLOVE, POWDERED
Download PDF Hycare Intl. Co., Ltd.