Cleared Traditional

MASK, SURGICAL APPAREL (K911334) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911334 · Thai Hospital Products Co., Ltd. · General Hospital
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Aug 1991
Decision
156d
Days
Class 2
Risk

K911334 is an FDA 510(k) clearance for the MASK, SURGICAL APPAREL. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Thai Hospital Products Co., Ltd. (Prachinburi, TH). The FDA issued a Cleared decision on August 29, 1991 after a review of 156 days - an extended review 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: 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 Thai Hospital Products Co., Ltd. devices

Submission Details

510(k) Number K911334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date August 29, 1991
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
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 401
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K911334.
3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95
K955382 · 3M Company · May 1996
3M SURGICAL MASK WITH FACE SHEILD
K940707 · 3M Company · May 1994
SURGICAL APPAREL
K914832 · W.L. Gore & Associates, Inc. · Feb 1992
TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK
K910110 · 3M Company · Mar 1991
3M BRAND EAR LOOP FACE MASK, 2000F
K910182 · 3M Company · Mar 1991
ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK
K890771 · 3M Company · Mar 1989