Cleared Traditional

K072406 - NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)

K072406 is an FDA 510(k) clearance for NON-STERILE, 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 207-day FDA review.

K072406 · Sgmp Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
207d
Days
Class 1
Risk

K072406 is an FDA 510(k) clearance for the NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR A.... 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 March 21, 2008 after a review of 207 days - an extended review 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: 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 Sgmp Co., Ltd. devices

FDA 510(k) Submission Details - K072406

510(k) Number K072406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2007
Decision Date March 21, 2008
Days to Decision 207 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
78d slower than avg
Panel avg: 129d · This submission: 207d
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 K072406.
POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM
K072300 · Perusahaan Pelindung Getah (M) Sdn Bhd · May 2008
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE
K072614 · Matang Mfg. Sdn. Bhd. · Apr 2008
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
K072403 · Sgmp Co., Ltd. · Mar 2008
BLUE LATEX EXAM GLOVES NON STERILE CHLORINATED POWDER FREE
K073299 · Betel Care Sdn. Bhd. · Mar 2008
SINGLE USE, DISPOSABLE, BLUE COLOR, POWDER FREE LATEX PATIENT EXAMINATION GLOVE
K072802 · Ultrawin Sdn Bhd · Feb 2008
MEDICAL GLOVE SERIES
K072145 · Zhanjiang Jiali Glove Products Co., Ltd. · Feb 2008