Cleared Traditional

K973831 - PRE-POWDERED PATIENT EXAMINATION GLOVE

K973831 is an FDA 510(k) clearance for PRE-POWDERED PATIENT EXAMINATION GLOVE, manufactured by Safe Glove , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K973831 · Safe Glove , Ltd. · General Hospital
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Jan 1998
Decision
91d
Days
Class 1
Risk

K973831 is an FDA 510(k) clearance for the PRE-POWDERED PATIENT EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Safe Glove , Ltd. (Glendale, US). The FDA issued a Cleared decision on January 6, 1998 after a review of 91 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 Safe Glove , Ltd. devices

FDA 510(k) Submission Details - K973831

510(k) Number K973831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1997
Decision Date January 06, 1998
Days to Decision 91 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
38d faster than avg
Panel avg: 129d · This submission: 91d
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 445
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K973831.
POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE
K973830 · Safe Glove , Ltd. · Jan 1998
SHENG HO
K964819 · Shang HO Industrial Corp. , Ltd. · Jan 1998
PATIENT EXAMINATION POWDER-FREE GLOVES
K973020 · Wear Safe Malaysia Sdn. Bhd. · Jan 1998
POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM)
K974065 · Tillotson Healthcare Corp. · Jan 1998
EVERGREEN NON-STERILE POWDERED LATEX EXAMINATION GLOVE
K974191 · Yty Industry (Manjung) Sdn Bhd · Dec 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973913 · Pwa Industries Sdn. Bhd. · Dec 1997