Cleared Traditional

K964358 - AMSEAL SURGICAL FACE MASK

K964358 is an FDA 510(k) clearance for AMSEAL SURGICAL FACE MASK, manufactured by American Seal Co.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K964358 · American Seal Co. · General Hospital
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Feb 1997
Decision
105d
Days
Class 2
Risk

K964358 is an FDA 510(k) clearance for the AMSEAL SURGICAL FACE MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by American Seal Co. (Hayward, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all American Seal Co. devices

FDA 510(k) Submission Details - K964358

510(k) Number K964358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date February 14, 1997
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
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 464
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K964358.
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