Cleared Traditional

K160337 - Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns

K160337 is an FDA 510(k) clearance for Safecare Open Back Protective Gowns and..., manufactured by Bam Corporation Limited. The device is a Class 2 General Hospital device with product code QPC cleared through the Traditional 510(k) pathway after a 515-day FDA review.

K160337 · Bam Corporation Limited · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K160337

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
386d slower than avg
Panel avg: 129d · This submission: 515d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QPC Device Classification - Class 2, Special Controls

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 11
Devices cleared under the same product code (QPC) and FDA review panel - the closest regulatory comparables to K160337.
Donagamex Blue Performance Protective Gown
K203821 · Dong Nai Garment Corporation (Donagamex) · Dec 2021
ProTEC-USA EZDoff Gown
K210405 · Cadillac Products, Inc. · Dec 2021
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
K182830 · Cardinal Health200, LLC · Apr 2019
K160337 · Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
Download PDF FDA Summary Bam Corporation Limit…