Cleared Traditional

K982716 - OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM

K982716 is an FDA 510(k) clearance for OMNIGRACE LATEX EXAMINATION GLOVE, manufactured by Omnigrace (Thailand) , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K982716 · Omnigrace (Thailand) , Ltd. · General Hospital
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Nov 1998
Decision
118d
Days
Class 1
Risk

K982716 is an FDA 510(k) clearance for the OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Omnigrace (Thailand) , Ltd. (Hatyai, Songkhla, TH). The FDA issued a Cleared decision on November 30, 1998 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Omnigrace (Thailand) , Ltd. devices

FDA 510(k) Submission Details - K982716

510(k) Number K982716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1998
Decision Date November 30, 1998
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 479
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K982716.
CHLORINATED, POLYMER-COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K983723 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998
UNISEAL GLOVES LOW PROTEIN POWDERED
K981979 · American Healthcare Products (M) Sdn Bhd · Nov 1998
NON-STERILE E.P. LATEX EXAMINATION GLOVE
K982453 · Ansell Perry · Nov 1998
MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
K982877 · Matang Mfg. Sdn. Bhd. · Nov 1998
SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
K982416 · Shun Thai Rubber Gloves Industry Co., Ltd. · Nov 1998
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · Siam Sempermed Corp., Ltd. · Nov 1998