Cleared Traditional

K100975 - NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED, COLOR BLUE

K100975 is an FDA 510(k) clearance for NITRIL EXAM GLOVE, manufactured by Jiangsu Sunshine Plastic Products, Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K100975 · Jiangsu Sunshine Plastic Products, Co., Ltd. · General Hospital
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Aug 2010
Decision
130d
Days
Class 1
Risk

K100975 is an FDA 510(k) clearance for the NITRIL EXAM GLOVE, PRE-POWERED COLOR WHITE, NITRILE EXAM GLOVE, PRE-POWDERED,.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Jiangsu Sunshine Plastic Products, Co., Ltd. (Taipei County, TW). The FDA issued a Cleared decision on August 17, 2010 after a review of 130 days - within the typical 510(k) review window.

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 Jiangsu Sunshine Plastic Products, Co., Ltd. devices

FDA 510(k) Submission Details - K100975

510(k) Number K100975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2010
Decision Date August 17, 2010
Days to Decision 130 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 129d · This submission: 130d
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 784
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K100975.
NUGARD NITILE GREY COLOR
K102230 · Terang Nusa Sdn Bhd · Sep 2010
NON-STERILE, POWDER FREE BLACK NITRILE EXAMINATION GLOVES WITH CHERRY FLAVOR
K101646 · Sgmp Co., Ltd. · Sep 2010
KIMBERLY-CLARK PURPLE NITRILE XTRA* STERILE POWDER-FREE EXAM GLOVE (CHEMOTHERAPY GLOVE) - 12 STERILE PAIRS
K102032 · Kimberly-Clark Corp. · Sep 2010
LAGLOVE BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE (PINK COLOR)
K093335 · La Glove (M) Sdn. Bhd. · Jun 2010
MICRO-TOUCH NITRILE
K093523 · Ansell Healthcare Products, LLC · Mar 2010
MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K093726 · Medline Industries, Inc. · Feb 2010