Cleared Traditional

K991155 - CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES

K991155 is an FDA 510(k) clearance for CHLORINATED POWDER FREE LATEX EXAMINATI..., manufactured by C.V. Anlis Abadi International. 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.

K991155 · C.V. Anlis Abadi International · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
76d
Days
Class 1
Risk

K991155 is an FDA 510(k) clearance for the CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by C.V. Anlis Abadi International (Medan, ID). The FDA issued a Cleared decision on June 21, 1999 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.

View all C.V. Anlis Abadi International devices

FDA 510(k) Submission Details - K991155

510(k) Number K991155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1999
Decision Date June 21, 1999
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 602
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K991155.
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDER FREE CONTAINING 50 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN
K991750 · Brightsway Holdings Sdn Bhd · Jun 1999
BRIGHTWAY BRAND BLUE COLOR LATEX EXAMINATION GLOVE, POWDERED CONTAINING 150 MLGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
K991752 · Brightsway Holdings Sdn Bhd · Jun 1999
MEDTEXX POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTA\
K991153 · Medtexx Industries (Thai) Co. , Ltd. · Jun 1999
HEALTH + AID PREMIUM POWDER FREE LATEX EXAMINATION GLOVES
K991305 · M.R.G. Industries Sdn. Bhd. · Jun 1999
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O
K991742 · Yty Industry (Manjung) Sdn Bhd · Jun 1999
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)
K991686 · Arista Latindo Industrial Ltd. P.T · Jun 1999