Cleared Traditional

K991457 - DISPOSABLE VINYL SYNTHETIC EXAM GLOVES, POWDER FREE

K991457 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 66-day FDA review.

K991457 · Shanghai Palomar Mountain Industries, Inc. · General Hospital
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Jul 1999
Decision
66d
Days
Class 1
Risk

K991457 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 July 1, 1999 after a review of 66 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 - K991457

510(k) Number K991457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1999
Decision Date July 01, 1999
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
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 K991457.
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
TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE
K992122 · Maxxim Medical · Jul 1999
POWDER FREE VINYL EXAMINATION GLOVES
K983856 · Shijiazhuang Brethern Plastic Co., Ltd. · Jun 1999
POWDERED VINYL EXAMINATION GLOVE
K983893 · Shijiazhuang Brethern Plastic Co., Ltd. · Jun 1999
BROTHERS, VINYL, POWDER-FREE, PATIENT EXAMINATION GLOVES
K991085 · Long First (Xiamen) Co., Ltd. · May 1999