Cleared Traditional

K893756 - SURGICARE (R) SPECIALTY EXAMINATION GLOVES

K893756 is an FDA 510(k) clearance for SURGICARE SPECIALTY EXAMINATION GLOVES, manufactured by Inter Continental Health Care. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K893756 · Inter Continental Health Care · General Hospital
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Jul 1989
Decision
74d
Days
Class 1
Risk

K893756 is an FDA 510(k) clearance for the SURGICARE (R) SPECIALTY EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Inter Continental Health Care (Boston, US). The FDA issued a Cleared decision on July 28, 1989 after a review of 74 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.

FDA 510(k) Submission Details - K893756

510(k) Number K893756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date July 28, 1989
Days to Decision 74 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 129d · This submission: 74d
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 1355
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K893756.
LATEX EXAM GLOVES (MFG. GUANGDONG ZHONGSHAN)
K893143 · Guangzhou Chemicals Import & Export Corp. · Jul 1989
LATEX EXAM GLOVES (MFG. GUANGZHOU NO. 11 RUBBER)
K893144 · Guangzhou Chemicals Import & Export Corp. · Jul 1989
MEDI, ULTRA, CURI EXAM GLOVES
K893057 · Sinjaca Inc. Dba Sic Medical & Surgical Supplies · Jul 1989
LATEX EXAMINATION GLOVES
K893825 · Frank W. Winne & Son, Inc. · Jul 1989
LATEX EXAMINATION GLOVES
K894195 · Jiahn Chiaur Enterprise Co., Ltd. · Jul 1989
LATEX EXAMINATION GLOVES
K893295 · Lee AH Sheng Ent. Co., Ltd. · Jul 1989
K893756 · SURGICARE (R) SPECIALTY EXAMINATION GLOVES
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