Cleared Traditional

K974442 - PRE-POWDERED NITRILE EXAMINATION GLOVES

K974442 is an FDA 510(k) clearance for PRE-POWDERED NITRILE EXAMINATION GLOVES, manufactured by P.T. Latexindo Tobaperkasa. The device is a Class 2 Orthopedic device with product code LZY cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K974442 · P.T. Latexindo Tobaperkasa · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 1998
Decision
41d
Days
Class 2
Risk

K974442 is an FDA 510(k) clearance for the PRE-POWDERED NITRILE EXAMINATION GLOVES. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal Ball (product code LZY), Class II - Special Controls.

Submitted by P.T. Latexindo Tobaperkasa (Medan, ID). The FDA issued a Cleared decision on January 5, 1998 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - the FDA orthopedic device regulatory 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 P.T. Latexindo Tobaperkasa devices

FDA 510(k) Submission Details - K974442

510(k) Number K974442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1997
Decision Date January 05, 1998
Days to Decision 41 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 122d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZY Device Classification - Class 2, Special Controls

Product Code LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Devices cleared under the same product code (LZY) and FDA review panel - the closest regulatory comparables to K974442.
TANDEM Hip System
K231448 · Smith & Nephew, Inc. · Jul 2023
ENDO HEAD
K111145 · Medacta International · Aug 2011
IONGUARD TITANIUM MODULAR HEADS
K915548 · Biomet, Inc. · Mar 1992
MODULAR CATHCART FRACTURE SYSTEM
K903084 · Depuy, Inc. · Oct 1990
UNI-POLAR HEAD
K896580 · Richards Medical Co., Inc. · Feb 1990
FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR
K892059 · Protek, Inc. · Jul 1989