Cleared Traditional

K101646 - NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR

K101646 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 LZA cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K101646 · Sgmp Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
89d
Days
Class 1
Risk

K101646 is an FDA 510(k) clearance for the NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sgmp Co., Ltd. (Sparks, US). The FDA issued a Cleared decision on September 8, 2010 after a review of 89 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 - K101646

510(k) Number K101646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2010
Decision Date September 08, 2010
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 1056
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K101646.
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG)
K102074 · Gx Corporation Sdn Bhd · Nov 2010
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K102096 · Syntex Healthcare Products Co., Ltd. · Oct 2010
NUGARD NITILE GREY COLOR
K102230 · Terang Nusa Sdn Bhd · Sep 2010
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032 · Kimberly-Clark Corp. · Sep 2010
POWDER FREE NITRILE (DARK BLUE) EXAMINATION GLOVES
K092874 · Quality Gallant Sdn. Bhd. · Jun 2010
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
K093335 · La Glove (M) Sdn. Bhd. · Jun 2010