Cleared Traditional

K993231 - SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES

K993231 is an FDA 510(k) clearance for SENSI-PRO DISPOSABLE POWDERED VINYL SYN..., manufactured by Shinemound Enterprise, Inc.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K993231 · Shinemound Enterprise, Inc. · General Hospital
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Oct 1999
Decision
30d
Days
Class 1
Risk

K993231 is an FDA 510(k) clearance for the SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE P.... Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shinemound Enterprise, Inc. (North Billerica, US). The FDA issued a Cleared decision on October 27, 1999 after a review of 30 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.

FDA 510(k) Submission Details - K993231

510(k) Number K993231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1999
Decision Date October 27, 1999
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 749
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K993231.
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992797 · Shijiazhuang Hongxiang Plastics Products Co; , Ltd. · Nov 1999
PRE-POWDERED NON-STERILE VINYL EXAMINATION GLOVES
K983613 · Shanghai Jiatai Plastic Products Co., Ltd. · Oct 1999
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
K992156 · Ansell Perry · 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
SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE
K992865 · Maxxim Medical · Oct 1999
K993231 · SENSI-PRO DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES WITH WHITE PIGMENT ADDITIVES
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