Cleared Traditional

K983608 - EVERGREEN NON-STERILE

K983608 is an FDA 510(k) clearance for EVERGREEN NON-STERILE, manufactured by Yty Industry (Manjung) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K983608 · Yty Industry (Manjung) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
22d
Days
Class 1
Risk

K983608 is an FDA 510(k) clearance for the EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATIO.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Yty Industry (Manjung) Sdn Bhd (Crofton, US). The FDA issued a Cleared decision on November 5, 1998 after a review of 22 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 Yty Industry (Manjung) Sdn Bhd devices

FDA 510(k) Submission Details - K983608

510(k) Number K983608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1998
Decision Date November 05, 1998
Days to Decision 22 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 129d · This submission: 22d
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 225
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K983608.
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972615 · Wembley Rubber Products (M) Sdn Bhd · Jan 1999
TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K983145 · Shen Wei (Usa), Inc. · Jan 1999
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · Siam Sempermed Corp., Ltd. · Nov 1998
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982806 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K982807 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K980916 · Perusahaan Getah Asas Sdn. Bhd. · Aug 1998