Cleared Traditional

K004048 - SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K004048 is an FDA 510(k) clearance for SENSIGRIP LTC POWDER FREE LATEX EXAMINA..., manufactured by Tillotson Healthcare Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K004048 · Tillotson Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
39d
Days
Class 1
Risk

K004048 is an FDA 510(k) clearance for the SENSIGRIP LTC POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Tillotson Healthcare Corp. (Bedford, US). The FDA issued a Cleared decision on February 6, 2001 after a review of 39 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 Tillotson Healthcare Corp. devices

FDA 510(k) Submission Details - K004048

510(k) Number K004048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2000
Decision Date February 06, 2001
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 813
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K004048.
LATEX EXAMINATION GLOVES-POWDER FREE
K010356 · Enzymic Technologies Sdn Bhd · Mar 2001
NONSTERILE POWDERED PURPLE LATEX EXAMINATION GLOVES, WITH & WITHOUT GRAPE SCENT WITH PROTEIN LABELING (200 MICROGRAMS OR
K010095 · Sgmp Co., Ltd. · Feb 2001
JK GLOVES PRE-POWDERED LATEX EXAMINATION GLOVE
K010231 · Jk Gloves Sdn. Bhd. · Feb 2001
POWDERED LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMSPER OR LESS)
K003737 · Perusahaan Getah Asas Sdn. Bhd. · Feb 2001
GUTHRIE SHIELD PLUS BLUE LATEX EXAMINATION GLOVES (POWDER-FREE)
K010078 · Guthrie Medicare Products (Melaka) Sdn Bhd · Jan 2001
FORMULA ONE POWDERED LATEX EXAMINATION GLOVE, WITH PROTEIN CONTENT LABELING CLAIM 200 MICROGRAMS OR LESS AND MADE FROM A
K002719 · Tillotson Healthcare Corp. · Jan 2001