Cleared Traditional

K992100 - PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED

K992100 is an FDA 510(k) clearance for PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAM..., 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 38-day FDA review.

K992100 · Shanghai Palomar Mountain Industries, Inc. · General Hospital
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Jul 1999
Decision
38d
Days
Class 1
Risk

K992100 is an FDA 510(k) clearance for the PVC (POLYVINYL CHLORIDE) SYNTHETIC EXAMINATION GLOVES, POWDERED. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai Palomar Mountain Industries, Inc. (Songjiang Shanghai, CN). The FDA issued a Cleared decision on July 29, 1999 after a review of 38 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 - K992100

510(k) Number K992100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1999
Decision Date July 29, 1999
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 K992100.
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
K992107 · General Gloves Corp. · Aug 1999
DISPOSABLE PVC SYNTHETIC EXAMINATION GLOVES, POWDER FREE
K992017 · Shanghai Antares Industries, Inc. · Aug 1999
VINYL POWDERED EXAM GLOVE / CAT.# 15-020
K992289 · Vitalcare Group, Inc. · Aug 1999
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992206 · Shanghai China Star Corp · Jul 1999
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE)
K991951 · Safeskin Corp. · Jul 1999
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
K992205 · Shanghai China Star Corp · Jul 1999