Cleared Traditional

K051777 - NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)

K051777 is an FDA 510(k) clearance for NITRILE POWDER FREE EXAMINATION GLOVES ..., manufactured by Hartalega Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K051777 · Hartalega Sdn Bhd · General Hospital
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Aug 2005
Decision
42d
Days
Class 1
Risk

K051777 is an FDA 510(k) clearance for the NITRILE POWDER FREE EXAMINATION GLOVES (BLUE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on August 12, 2005 after a review of 42 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 Hartalega Sdn Bhd devices

FDA 510(k) Submission Details - K051777

510(k) Number K051777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2005
Decision Date August 12, 2005
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 907
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K051777.
NON-STERILE, POWDER-FREE NITRILE BLUE & WHITE EXAMINATION GLOVES
K052502 · Yty Industry (Manjung) Sdn Bhd · Nov 2005
POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE
K052877 · Syntex Healthcare Products Co., Ltd. · Nov 2005
NON-STERILE POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE, WITH VITAMIN E
K052890 · Siam Sempermed Corp., Ltd. · Oct 2005
NITRILE POWDERED EXAMINATION GLOVES (BLUE)
K051778 · Hartalega Sdn Bhd · Jul 2005
VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR)
K051662 · Grand Work Plastic Products Co., Ltd. · Jul 2005
POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES
K050968 · Pt. Medisafe Technologies · Jul 2005