# K240438: CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)

- Pathway: 510(k) (Traditional)
- Applicant: Comercializadora Brever
- Decided: Nov 4, 2024 after 264 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K881471 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171533: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap, Ahlstrom Nonwovens, LLC (2017) Summary page 6.

## Indications for use
CDB Hospital ® Sterilization Wraps intended to be used to enclose another medical device that is to be sterilized by a healthcare provider via the following: • Pre-vacuum Steam 270°F/132°C for 4 minutes • Advanced Sterilization Products (ASP) STERRAD® 100S • Advanced Sterilization Products (ASP) STERRAD® 100NX (Standard, Express and Flex cycles) • STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems (Lumen, Non Lumen and Flexible Cycles) The wrap is intended to allow sterilization of the enclosed medical device(s) and maintain sterility of the enclosed device(s) until used. Pre-Vacuum Steam Sterilization: • Validated for dry time of 30 minutes for 44gsm. • Validated for dry time of 30 minutes for 70gsm. • Validated maximum weight of 6 lbs for 44 gsm. • Validated maximum weight of 15 lbs for 70 gsm. • All models of CDB Hospital ® Sterilization Wraps validated for pre-vacuum steam sterilization with stainless steel lumens of 3 mm diameter or larger and length 400 mm or shorter as part of the load. Advanced Sterilization Products (ASP) STERRAD® 100S Sterilization: All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100S sterilization with stainless steel lumens as part of the load with a maximum weight of 10.7lbs. Advanced Sterilization Products (ASP) STERRAD® 100NX Sterilization: All models of CDB Hospital® Sterilization Wraps validated with ASP STERRAD® 100NX sterilization cycles are detailed below: VALIDATED ADVANCED STERILIZATION PRODUCTS (ASP) STERRAD® 100NX CYCLES Advanced Sterilization Products (ASP) STERRAD® System and Cycle Intended Load for 100NX Standard Cycle: Reusable metal and non-metal medical devices, including up to 10 lumens of the following dimensions per chamber load: • An inside diameter of 0.7mm or larger and a length of 200mm or shorter of single channel stainless steel lumens. Intended Load for 100NX Flex Cycle: One or two single-channel flexible endoscopes with or without a silicone mat. Flexible endoscope may contain: A single channel Teflon/PE/PTFE lumen with an inside diameter of 1 mm or larger and a length of 850 mm or shorter (a maximum of two flexible endoscopes, one per tray per sterilization cycle). Intended Load for 100NX Express Cycle: Non-lumened reusable metal and non-metal medical devices requiring surface sterilization, or sterilization of mated stainless steel and titanium surfaces, and rigid or semi-rigid endoscopes without lumens. STERIS Amsco® V-PRO 1, STERIS Amsco® V-PRO 1 Plus, STERIS Amsco® V-PRO maX Low Temperature Sterilization Systems: • All models of CDB Hospital® Sterilization Wraps have been validated for use with STERIS V-PRO® cycles detailed below. • CDB Hospital® Sterilization Wraps were validated to be effectively aerated during the preprogrammed STERIS Amsco V-PRO® Sterilization Cycles. VALIDATED STERIS AMSCO® V-PRO CYCLES STERIS Amsco® V-PRO Cycle Intended Load for Lumen Cycle: Reusable metal and non-metal medical devices, including up to 20 stainless steel lumens with dimensions of 3.0mm diameter or larger and a length of 400mm or shorter. Intended Load for Non Lumen Cycle: Non lumened reusable metal and non-metal medical devices. Intended Load for Flexible Cycle: Single lumen surgical flexible endoscopes and bronchoscopes in the following load configuration: 1.) One tray containing a flexible endoscope with a light cord (if not integral to endoscope) and mat. The flexible endoscope having an inside diameter of 3 mm or larger and a length of 450 mm or shorter. 2.) An additional tray containing non-lumened medical devices.

Source page: https://510kreport.com/device/K240438
Methodology: https://510kreport.com/methodology