Cleared Traditional

K160337 - Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns (FDA 510(k) Clearance)

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

K160337 · Bam Corporation Limited · General Hospital
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Jul 2017
Decision
515d
Days
Class 2
Risk

K160337 is an FDA 510(k) clearance for the Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns. Classified as Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection (product code QPC), Class II - Special Controls.

Submitted by Bam Corporation Limited (Hong Kong, CN). The FDA issued a Cleared decision on July 7, 2017 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Bam Corporation Limited devices

Submission Details

510(k) Number K160337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2016
Decision Date July 07, 2017
Days to Decision 515 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
387d slower than avg
Panel avg: 128d · This submission: 515d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPC Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
Definition A Non-sterile, Non-isolation Gown Intended To Be Worn By Healthcare Personnel To Provide Moderate Or High Barrier Protection In Non-sterile And Non Patient Isolation Situations. Gowns With Antimicrobial/antiviral Agents Or Claims Are Excluded.
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 - QPC Gown, Non-sterile, Non-isolation, Intended To Provide Moderate Or High Barrier Protection

All 9
Devices cleared under the same product code (QPC) and FDA review panel - the closest regulatory comparables to K160337.
VR® Personal Protective Level 3 Gown (VR Gowns)
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AAMI Level 4 Protective
K242689 · Azac Group · Jan 2025
Medline Open-back Level 3 Protective Gown
K233526 · Medline Industries, LP · Mar 2024
PolyWear® Personal Protective Level 3 Gown
K230384 · PolyConversions, Inc. · Aug 2023
Protective Gown AAMI Level 4
K222128 · Kenpax International Limited · Aug 2023
Dukal Corporation AAMI Level 4 Open-Back Protective Gown
K212464 · Dukal Corporation · Mar 2022