Cleared Traditional

K981600 - LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED

K981600 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVES BUBBLE GUM FLA..., manufactured by Young Innovations, LLC Dba Plak Smacker. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K981600 · Young Innovations, LLC Dba Plak Smacker · General Hospital
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Nov 1998
Decision
182d
Days
Class 1
Risk

K981600 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Young Innovations, LLC Dba Plak Smacker (Riverside, US). The FDA issued a Cleared decision on November 2, 1998 after a review of 182 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Young Innovations, LLC Dba Plak Smacker devices

FDA 510(k) Submission Details - K981600

510(k) Number K981600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1998
Decision Date November 02, 1998
Days to Decision 182 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 slower than avg
Panel avg: 129d · This submission: 182d
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 478
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K981600.
SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
K982416 · Shun Thai Rubber Gloves Industry Co., Ltd. · Nov 1998
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · Siam Sempermed Corp., Ltd. · Nov 1998
EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK
K983608 · Yty Industry (Manjung) Sdn Bhd · Nov 1998
UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
K982611 · Uniject Gloves Pcl · Nov 1998
TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K982872 · Tg Medical Sdn. Bhd. · Oct 1998
EXTRA-CARE POWDER-FREE EXAMINATION GLOVE
K983175 · Ultrawin Sdn Bhd · Oct 1998