Cleared Traditional

K963458 - PADDED MITTS/PADDED-PLUS MITTS/FINGER S...

K963458 is the FDA 510(k) clearance for PADDED MITTS/PADDED-PLUS MITTS/FINGER S... by Skil-Care Corp.. It is a Class 1 General Hospital device (product code FMQ) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K963458 · Skil-Care Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
45d
Days
Class 1
Risk

K963458 is an FDA 510(k) clearance for the PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDE.... Classified as Restraint, Protective (product code FMQ), Class I - General Controls.

Submitted by Skil-Care Corp. (Yonkers, US). The FDA issued a Cleared decision on October 18, 1996 after a review of 45 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6760 - 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 Skil-Care Corp. devices

Submission Details

510(k) Number K963458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date October 18, 1996
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMQ Restraint, Protective
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6760
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 - FMQ Restraint, Protective

All 34
Devices cleared under the same product code (FMQ) and FDA review panel - the closest regulatory comparables to K963458.
MEDLINE BODY HOLDER
K963360 · Medline Industries, Inc. · Oct 1996
MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT
K963362 · Medline Industries, Inc. · Oct 1996
MEDLINE PELVIC HOLDER
K963404 · Medline Industries, Inc. · Oct 1996
WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH
K963569 · Medline Industries, Inc. · Oct 1996
STRAIT JACKET
K963463 · Deroyal Industries, Inc. · Oct 1996
HEELBO QUILTED TORSO RESTRAINT
K963108 · Hollister, Inc. · Oct 1996