Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
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 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 1 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 1 |
| September 2026 | 1 |
| October 2026 | 0 |
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