Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K160337Substantially Equivalent

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns

Bam Corporation Limited, Hong Kong, CN / Traditional, Substantially Equivalent

K160337 is the FDA 510(k) clearance record for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns, a class II device, cleared for Bam Corporation Limited on under FDA product code QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection). FDA's definition for product code QPC reads: "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...". FDA records list one 510(k) clearance for Bam Corporation Limited. As of , FDA records show no recalls naming K160337.

Clearance record

Decision date
Received
(515 days to decision)
Product code
QPC Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bam Corporation Limited # 138 Shatin Rural Committee Rd., Shatin, N.T., Hong Kong, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPC

Trailing 12 months
3 clearances under product code QPC in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QPC, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260