Cleared Traditional

K090537 - POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

K090537 is an FDA 510(k) clearance for POWDER FREE VINYL PATIENT EXAMINATION G..., manufactured by Tangshan Jiteng 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 20-day FDA review.

K090537 · Tangshan Jiteng Plastic Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
20d
Days
Class 1
Risk

K090537 is an FDA 510(k) clearance for the POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Tangshan Jiteng Plastic Products Co., Ltd. (Bei Si Huan Zho, Beijing, CN). The FDA issued a Cleared decision on March 19, 2009 after a review of 20 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.

FDA 510(k) Submission Details - K090537

510(k) Number K090537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2009
Decision Date March 19, 2009
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 K090537.
VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)
K090513 · Shandong Huayue Glove Co., Ltd. · May 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
K090691 · Shijiazhuang Benestar Plastic Co., Ltd. · May 2009
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE
K083931 · Quantum Co., Ltd. · Apr 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K083015 · Zibo Goldenline Plastic Product Co., Ltd. · Mar 2009
VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED)
K083600 · Quantum Co., Ltd. · Feb 2009
PATIENT VINYL EXAMINATION GLOVES, POWDERFREE, NON-STERILE
K083259 · Tangshan Zhongying Plastic Products Co., Ltd. · Feb 2009
K090537 · POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
Download PDF FDA Summary Tangshan Jiteng Plast…