# K182656: JAMBRO Single Core A Sterilization wrap

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Zhande Medical Supplies Co., Ltd.
- Decided: Jun 11, 2019 after 259 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: 6 generations back to K881471 (1988). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160755: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap, Ahlstrom Nonwovens, LLC (2016) Summary page 5.

## Most influential descendants
- K220133: Sterilization Wraps (2022), 0 descendants of its own

## Indications for use
JAMBRO Single Core A is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: • Gravity steam at 250°F/121°C for 30 minutes • Pre-vacuum steam at 270°F/132°C for 4 minutes Gravity steam and Pre-vacuum steam sterilization: Validated for dry times of 30 minutes for JAMBRO Single Core A Types of medical devices to be sterilized in the gravity cycle; • General purpose non-lumened reusable metal and nonmetal devices including devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc. Types of medical devices to be sterilized in the pre-vacuum cycle are; • General purpose reusable metal and nonmetal devices including devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors, as well as other general medical instruments having mated surfaces, knurled areas etc. • Up to 2 single channel stainless steel lumened devices of the following dimensions; An inside diameter of 3 mm or larger and a length of 400 mm or shorter; Color of wrap: Blue Size of wrap: 48 in x 48 in The maximum validated weight of load for JAMBRO Single Core A is 25 lbs. The wrap is intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility of the enclosed device(s) until used.

Source page: https://510kreport.com/device/K182656
Methodology: https://510kreport.com/methodology