Cleared Traditional

K052273 - POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE

K052273 is an FDA 510(k) clearance for POLYMER COATED LATEX EXAMINATION GLOVES, manufactured by Pt Mahakarya Inti Buana. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K052273 · Pt Mahakarya Inti Buana · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
39d
Days
Class 1
Risk

K052273 is an FDA 510(k) clearance for the POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt Mahakarya Inti Buana (Morawa, Sumut, ID). The FDA issued a Cleared decision on September 30, 2005 after a review of 39 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 - K052273

510(k) Number K052273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2005
Decision Date September 30, 2005
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 1287
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K052273.
POWDER FREE LATEX EXAMINATION GLOVES, SIZES SMALL, MEDIUM, LARGE, X-LARGE
K052709 · Pt.Shamrock Manufacturing Corp. · Nov 2005
FLEXISKIN POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
K051987 · Pt. Mandiri Inti Buana · Oct 2005
POWDERED LATEX PATIENT EXAMINATION GLOVES
K051913 · Shinemound Enterprise, Inc. · Sep 2005
B-CARE POWDER FREE LATEX EXAMINATION GLOVES
K051404 · B-Care Industries Co., Ltd. · Sep 2005
PRE-POWDERED STERILE EXAM GLOVES
K052214 · Kanam Latex Industries Pvt. , Ltd. · Sep 2005
NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING
K052016 · Sgmp Co., Ltd. · Sep 2005
K052273 · POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
Download PDF FDA Summary Pt Mahakarya Inti Bua…