Cleared Traditional

K964819 - SHENG HO

K964819 is an FDA 510(k) clearance for SHENG HO, manufactured by Shang HO Industrial Corp. , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K964819 · Shang HO Industrial Corp. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
400d
Days
Class 1
Risk

K964819 is an FDA 510(k) clearance for the SHENG HO. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shang HO Industrial Corp. , Ltd. (Taichung Hsien, TW). The FDA issued a Cleared decision on January 6, 1998 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Shang HO Industrial Corp. , Ltd. devices

FDA 510(k) Submission Details - K964819

510(k) Number K964819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1996
Decision Date January 06, 1998
Days to Decision 400 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
271d slower than avg
Panel avg: 129d · This submission: 400d
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 444
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K964819.
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · Sri Johani Sdn. Bhd. · Feb 1998
POWDERED GREEN LATEX EXAMINATION GLOVES
K980039 · Sri Johani Sdn. Bhd. · Feb 1998
POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE
K973830 · Safe Glove , Ltd. · Jan 1998
PATIENT EXAMINATION POWDER-FREE GLOVES
K973020 · Wear Safe Malaysia Sdn. Bhd. · Jan 1998
PRE-POWDERED PATIENT EXAMINATION GLOVE
K973831 · Safe Glove , Ltd. · Jan 1998
POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM)
K974065 · Tillotson Healthcare Corp. · Jan 1998