Cleared Traditional

K891141 - CARERITE FACE MASK

K891141 is an FDA 510(k) clearance for CARERITE FACE MASK, manufactured by Cost Rite Health Products, Inc.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K891141 · Cost Rite Health Products, Inc. · General Hospital
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Apr 1989
Decision
46d
Days
Class 2
Risk

K891141 is an FDA 510(k) clearance for the CARERITE FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Cost Rite Health Products, Inc. (Chatsworth, US). The FDA issued a Cleared decision on April 18, 1989 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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 Cost Rite Health Products, Inc. devices

FDA 510(k) Submission Details - K891141

510(k) Number K891141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1989
Decision Date April 18, 1989
Days to Decision 46 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 129d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 453
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K891141.
THE PROTECTOR II, LASER SURGICAL MASK
K902547 · Anago, Inc. · Sep 1990
TECNOL LAZER(TM) SURGICAL MASK
K896193 · Tecnol New Jersey Wound Care, Inc. · Feb 1990
SURGIFRESH SUB-MICRON MASK NO. 901008-000
K893417 · Texas Medical Products, Inc. · Jun 1989
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989
ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK
K881618 · 3M Company · May 1988
TECNOL LASER SURGICAL MASK
K874894 · Tecnol New Jersey Wound Care, Inc. · Mar 1988