Cleared Traditional

K121947 - ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES

K121947 is an FDA 510(k) clearance for ETS BLUE POWDER-FREE PATIENT NITRILE EX..., manufactured by Northstar Healthcare Holdings. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K121947 · Northstar Healthcare Holdings · General Hospital
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Sep 2012
Decision
69d
Days
Class 1
Risk

K121947 is an FDA 510(k) clearance for the ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Northstar Healthcare Holdings (Hamilton, Bermuda, IE). The FDA issued a Cleared decision on September 10, 2012 after a review of 69 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 Northstar Healthcare Holdings devices

FDA 510(k) Submission Details - K121947

510(k) Number K121947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2012
Decision Date September 10, 2012
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 1168
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K121947.
ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
K120110 · Profit Point Manufacturing Sdn Bhd · Oct 2012
POWDER FREE BLACK NITRILE EXAMINATION GLOVES
K113393 · Tg Medical Sdn. Bhd. · Sep 2012
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K121528 · Shen Wei (Usa), Inc. · Sep 2012
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K122363 · Siam Sempermed Corp., Ltd. · Sep 2012
POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
K120890 · Shen Wei (Usa), Inc. · Aug 2012
NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
K121368 · Matang Mfg. Sdn. Bhd. · Aug 2012

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.