Cleared Traditional

K052016 - NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING

K052016 is an FDA 510(k) clearance for NON-STERILE POWDER FREE MULTICOLOR - RED, manufactured by Sgmp Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K052016 · Sgmp Co., Ltd. · General Hospital
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Sep 2005
Decision
37d
Days
Class 1
Risk

K052016 is an FDA 510(k) clearance for the NON-STERILE POWDER FREE MULTICOLOR - RED, BLUE, PURPLE AND YELLOW LATEX EXAMI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sgmp Co., Ltd. (Sparks, US). The FDA issued a Cleared decision on September 1, 2005 after a review of 37 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 Sgmp Co., Ltd. devices

FDA 510(k) Submission Details - K052016

510(k) Number K052016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2005
Decision Date September 01, 2005
Days to Decision 37 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
92d faster than avg
Panel avg: 129d · This submission: 37d
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 671
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K052016.
POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE
K052273 · Pt Mahakarya Inti Buana · 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
STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN CLAIM (50 UG OR LESS)
K051329 · Siam Sempermed Corp., Ltd. · Jul 2005
POWDERED LATEX PATIENT EXAMINATION GLOVES
K051465 · P.T. Anlis Abadi Internasional · Jul 2005
COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET)
K051345 · Glovco (M) Sdn. Bhd. · Jun 2005