Cleared Traditional

K893075 - PATIENT EXAMINATION GLOVES

K893075 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES, manufactured by Quality Latex Corp. Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K893075 · Quality Latex Corp. Sdn Bhd · General Hospital
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Nov 1989
Decision
208d
Days
Class 1
Risk

K893075 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Quality Latex Corp. Sdn Bhd (Malaysia, MY). The FDA issued a Cleared decision on November 7, 1989 after a review of 208 days - an extended review 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: 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.

FDA 510(k) Submission Details - K893075

510(k) Number K893075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date November 07, 1989
Days to Decision 208 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 129d · This submission: 208d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K893075.
LATEX EXAMINATION GLOVES
K893350 · Pan Africa Exports , Ltd. · Nov 1989
LATEX EXAMINATION GLOVES
K895552 · Jung Hua Co. · Nov 1989
SHANNON LATEX MEDICAL GLOVES
K895804 · Cashmor Mfg. , Ltd. · Nov 1989
LATEX EXAMINATION GLOVES
K893804 · S-P Pantec Co., Ltd. · Nov 1989
LATEX EXAM GLOVES (MFG: CHINA NAT CHEM CONST CORP)
K894194 · Invent Ent. (U.S.A.) Corp. · Nov 1989
LATEX PATIENT EXAMINATION GLOVES
K894967 · Yan Ling Rubber Products Co. · Nov 1989
K893075 · PATIENT EXAMINATION GLOVES
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