Broadline OR Towels
by Broadline Medical Industries 510(k)
Active
510(k) K991667
Overview
Broadline OR Towels are surgical towels designed for use in the operating room. They are made of 100% cotton, hand-sewn, vacuumed, and de-linted for maximum absorbency and to maintain a sterile field around the surgical site.
These towels are supplied in sterile and non-sterile forms, available in white, blue, and green. They are intended for single use in healthcare settings and are authorized under FDA 510(k) clearance K991667 with product code KKX.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK991667 | Date27 Sep 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KKX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4370
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Other devices from Broadline Medical Industries
Questions
What are Broadline OR Towels used for?
Broadline OR Towels are surgical towels designed for use in the operating room to maintain a sterile field around the surgical site, providing maximum absorbency during procedures.
Are Broadline OR Towels sterile or non-sterile, and how are they supplied?
Broadline OR Towels are supplied in both sterile and non-sterile forms, available in white, blue, and green colors, allowing healthcare facilities to choose based on procedural needs.
Are Broadline OR Towels intended for single use or reuse?
Broadline OR Towels are intended for single use in healthcare settings, as specified in their labeling, to ensure infection control and prevent cross-contamination.
What material are Broadline OR Towels made of, and how are they processed?
Broadline OR Towels are made of 100% cotton, hand-sewn, vacuumed, and de-linted to enhance absorbency and minimize lint, which helps maintain a clean surgical field.
What is the FDA authorization for Broadline OR Towels?
Broadline OR Towels are authorized under FDA 510(k) clearance K991667 with product code KKX, confirming their substantial equivalence to a legally marketed device.