Cleared Traditional

B-D(R) HYPOALLERGENIIC NON-STERILE PAT EXAM GLOVES (K913902) - FDA 510(k) Clearance

Class I General Hospital device.

K913902 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Sep 1991
Decision
26d
Days
Class 1
Risk

K913902 is an FDA 510(k) clearance for the B-D(R) HYPOALLERGENIIC NON-STERILE PAT EXAM GLOVES. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 25, 1991 after a review of 26 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.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K913902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1991
Decision Date September 25, 1991
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 - LYZ Vinyl Patient Examination Glove

All 83
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K913902.
SENSICARE POWDER FREE MEDICAL GLOVE
K925244 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1993
DERMACARE SYNTHETIC MEDICAL GLOVE
K914763 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
SENSICARE SYNTHETIC MEDICAL GLOVES
K915478 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1992
TRU-TOUCH POWDER FREE
K905503 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1991
TRU-TOUCH VINYL, NON-STERILE
K891719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
TRU-TOUCH VINYL, STERILE
K892327 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989