Cleared Traditional

K982897 - POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K982897 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVE WIT..., manufactured by Pt. Maja Agung Latexindo. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K982897 · Pt. Maja Agung Latexindo · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
128d
Days
Class 1
Risk

K982897 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 M.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Maja Agung Latexindo (Baldwin Park, US). The FDA issued a Cleared decision on December 23, 1998 after a review of 128 days - within the typical 510(k) review window.

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 Pt. Maja Agung Latexindo devices

FDA 510(k) Submission Details - K982897

510(k) Number K982897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1998
Decision Date December 23, 1998
Days to Decision 128 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
1d faster than avg
Panel avg: 129d · This submission: 128d
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 802
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K982897.
GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE
K983570 · Glove Seal Sdn Bhd · Jan 1999
MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE
K983827 · Sinetimed Latex Sdn Bhd · Jan 1999
BLOSSOM POWDERED LATEX EXAMINATION GLOVES
K984040 · Mexpo Intl., Inc. · Jan 1999
POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS)
K984019 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998
POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
K984020 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
K982901 · Vitalcare Group, Inc. · Dec 1998