Cleared Traditional

K981488 - GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION

K981488 is an FDA 510(k) clearance for GLOVE, manufactured by Oak Carolina, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K981488 · Oak Carolina, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
71d
Days
Class 1
Risk

K981488 is an FDA 510(k) clearance for the GLOVE, OAKTEX EXAMINATION, GLOVE, PATIENT EXAMINATION. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Oak Carolina, Inc. (Travelers Rest, US). The FDA issued a Cleared decision on July 7, 1998 after a review of 71 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 Oak Carolina, Inc. devices

FDA 510(k) Submission Details - K981488

510(k) Number K981488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1998
Decision Date July 07, 1998
Days to Decision 71 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
58d faster than avg
Panel avg: 129d · This submission: 71d
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 K981488.
VINYL PATIENT EXAMINATION POWDER FREE GLOVES, NON-STERILE
K982015 · Taian Plastics Products (Jingxing) Co., Ltd. · Aug 1998
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K982257 · Taian Plastics Products (Jingxing) Co., Ltd. · Aug 1998
SENSITEX EXAMINATION GLOVE
K981963 · Oak Carolina, Inc. · Jul 1998
DISPOSABLE SYNTHETIC PATIENT EXMINATION GLOVES, POWDER FREE
K980093 · Universal Gloves Corp. · Mar 1998
VINYL EXAMINATION GLOVES POWDER FREE
K974777 · Sun Flower Gloves Co., Ltd. · Jan 1998
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES
K974334 · Hong Huang Tang Industrial Co., Ltd. · Jan 1998