Cleared Traditional

K960841 - POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM

K960841 is an FDA 510(k) clearance for POWDER-FREE LATEX EXAM GLOVE W/HYPOALLE..., manufactured by Boston Medical Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K960841 · Boston Medical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
170d
Days
Class 1
Risk

K960841 is an FDA 510(k) clearance for the POWDER-FREE LATEX EXAM GLOVE W/HYPOALLERGENIC CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Boston Medical Corp. (Annapolis Junction, US). The FDA issued a Cleared decision on August 15, 1996 after a review of 170 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.

View all Boston Medical Corp. devices

FDA 510(k) Submission Details - K960841

510(k) Number K960841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1996
Decision Date August 15, 1996
Days to Decision 170 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
41d slower than avg
Panel avg: 129d · This submission: 170d
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 629
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K960841.
POWDERFREE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953955 · Codan Medlon, Inc. · Aug 1996
BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953956 · Codan Medlon, Inc. · Aug 1996
POWDERFREE BLUE LATEX EXAM GLOVES WITH PROTEIN CONTENT LABELING CLAIM
K953958 · Codan Medlon, Inc. · Aug 1996
PATIENT LATEX EXAMINATION GLOVES (POWDERED, NON STERILE)
K962650 · Sti Medical Sdn Bhd · Aug 1996
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT EXAMINATION GLOVES
K960225 · Tillotson Healthcare Corp. · Jul 1996
ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE
K960247 · Tillotson Healthcare Corp. · Jul 1996