Cleared Traditional

K992865 - SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE

K992865 is an FDA 510(k) clearance for SENSICARE XP VINYL POWDER FREE MEDICAL ..., manufactured by Maxxim Medical. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K992865 · Maxxim Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
49d
Days
Class 1
Risk

K992865 is an FDA 510(k) clearance for the SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Maxxim Medical (Oldsmar, US). The FDA issued a Cleared decision on October 13, 1999 after a review of 49 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 Maxxim Medical devices

FDA 510(k) Submission Details - K992865

510(k) Number K992865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1999
Decision Date October 13, 1999
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

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 637
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K992865.
SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
K993231 · Shinemound Enterprise, Inc. · Oct 1999
SENSI-PRO DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
K993240 · Shinemound Enterprise, Inc. · Oct 1999
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992555 · Shijiazhuang Great Vision Plastic Products Co., LT · Oct 1999
SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K992861 · Shijiazhuang Great Eagle Plastic Products Co., Ltd. · Oct 1999
SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
K992922 · Shijiazhuang Hongray Plastic Products Co., Ltd. · Oct 1999
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
K992271 · Shanghai Cosmos Corp. · Oct 1999