Cleared Traditional

K870312 - WHITE PLUME SURGICAL GAUZE FACE MASK

K870312 is the FDA 510(k) clearance for WHITE PLUME SURGICAL GAUZE FACE MASK by China National Medicines & Health Prod. I/E Corp.. It is a Class 2 General Hospital device (product code FXX) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K870312 · China National Medicines & Health Prod. I/E Corp. · General Hospital
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Feb 1987
Decision
27d
Days
Class 2
Risk

K870312 is an FDA 510(k) clearance for the WHITE PLUME SURGICAL GAUZE FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by China National Medicines & Health Prod. I/E Corp. (Suite 500, Washington, US). The FDA issued a Cleared decision on February 24, 1987 after a review of 27 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 China National Medicines & Health Prod. I/E Corp. devices

Submission Details

510(k) Number K870312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date February 24, 1987
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 434
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K870312.
KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001
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K832281 · Abco Dealers, Inc. · Aug 1983