Cleared Traditional

K990117 - DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

K990117 is an FDA 510(k) clearance for DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, manufactured by Shanghai Palomar Mountain Industries, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K990117 · Shanghai Palomar Mountain Industries, Inc. · General Hospital
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Feb 1999
Decision
37d
Days
Class 1
Risk

K990117 is an FDA 510(k) clearance for the DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Palomar Mountain Industries, Inc. (Shanghai, CN). The FDA issued a Cleared decision on February 19, 1999 after a review of 37 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 Shanghai Palomar Mountain Industries, Inc. devices

FDA 510(k) Submission Details - K990117

510(k) Number K990117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1999
Decision Date February 19, 1999
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 129d · This submission: 37d
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 205
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K990117.
BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES
K991085 · Long First (Xiamen) Co., Ltd. · May 1999
BROTHERS VINYL, POWDERED, PATIENT EXAMINATION GLOVES
K990946 · Long First (Xiamen) Co., Ltd. · May 1999
DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDERED
K990081 · Shanghai Palomar Mountain Industries, Inc. · Feb 1999
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K984460 · Shanghai Huamao Gloves Co., Ltd. · Feb 1999
PRE-POWDER VINYL PATIENT EXAMINATION GLOVES
K984461 · Shanghai Huamao Gloves Co., Ltd. · Feb 1999
VINYL EXAMINATION GLOVES, PREPOWDERED USP
K984094 · Trans Ancient Products Co., Ltd. · Jan 1999