Cleared Traditional

K897139 - LATEX PATIENT EXAMINATION GLOVES

K897139 is an FDA 510(k) clearance for LATEX PATIENT EXAMINATION GLOVES, manufactured by Kanam Latex Industries Pvt. , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K897139 · Kanam Latex Industries Pvt. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
27d
Days
Class 1
Risk

K897139 is an FDA 510(k) clearance for the LATEX PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kanam Latex Industries Pvt. , Ltd. (Raphine, US). The FDA issued a Cleared decision on January 23, 1990 after a review of 27 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 - K897139

510(k) Number K897139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1989
Decision Date January 23, 1990
Days to Decision 27 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 129d · This submission: 27d
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 K897139.
SEAMLESS LATEX PATIENT EXAMINATION GLOVES
K891490 · Med-Care Sdn. Bhd. · Jan 1990
PATIENT EXAMINATION GLOVES (LATEX)
K892307 · Guangming Latex Factory · Jan 1990
EXAM GLOVES (MFG. GUEY HER ENT. CO. LTD)
K893025 · Wen Hao, Inc. · Jan 1990
SURETEX LATEX EXAMINATION GLOVES
K900212 · Gulf Medical Technologies, Inc. · Jan 1990
J.M. PATIENT EXAMINATION GLOVES
K891624 · Jann Maw (U.S.A.), Inc. · Jan 1990
PATIENT EXAMINATION GLOVES
K893074 · Taba Gloves Pvt. , Ltd. · Jan 1990
K897139 · LATEX PATIENT EXAMINATION GLOVES
Download PDF Kanam Latex Industrie…