Cleared Traditional

K100977 - PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE

K100977 is an FDA 510(k) clearance for PRE-POWDERED VINYL PATIENT EXAMINATION ..., manufactured by Jiangsu Sunshine Plastic Products, Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K100977 · Jiangsu Sunshine Plastic Products, Co., Ltd. · General Hospital
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Aug 2010
Decision
126d
Days
Class 1
Risk

K100977 is an FDA 510(k) clearance for the PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Jiangsu Sunshine Plastic Products, Co., Ltd. (Taipei County, TW). The FDA issued a Cleared decision on August 12, 2010 after a review of 126 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.

FDA 510(k) Submission Details - K100977

510(k) Number K100977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2010
Decision Date August 12, 2010
Days to Decision 126 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
3d faster than avg
Panel avg: 129d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 - LYZ Vinyl Patient Examination Glove

All 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K100977.
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102098 · Hong DI Plastic Products Co., Ltd. · Sep 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K101358 · Hebei Handform Plastic Products Co., Ltd. · Aug 2010
POWDER - FREE PATIENT EXAMINATION GLOVES
K101565 · Zibio Yingjie Medical Products Co., Ltd. · Aug 2010
POWDER FREE NON-STERILE VINYL EXAMINATION GLOVE
K100978 · Jiangsu Sunshine Plastic Products, Co., Ltd. · Aug 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K100963 · Hebei Shenzichen Plastic & Rubber Products Co., LT · Aug 2010
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K101663 · Hebei Excellent Plastic Co., Ltd. · Jul 2010
K100977 · PRE-POWDERED VINYL PATIENT EXAMINATION GLOVE, NON-STERILE
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