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510(k) Data Aggregation
K Number
K091720Device Name
SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM
Manufacturer
SKLAR CORP.
Date Cleared
2010-04-09
(302 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
SKLAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SklarLite™ Rigid Sterilization Container System is intended for use in hospitals and health care facilities to contain other medical devices that are to be sterilized. Containers allow sterilization of the enclosed medical devices, including surfaces and lumens, using high vacuum steam sterilizers at 270°F for 4 minutes with 30 minutes (minimum) dry time.
The containers have been validated for sterilization of up to two instruments with lumens no smaller than 2.4 mm I.D. in diameter and no longer than 380 mm in length for the Full-Size (580mm x 280mm) and Mid-Size (465mm x 280mm) containers, and no smaller than 1.0 mm I.D. in diameter and no longer than 250 mm in length for the Half-Size (285mm x 280mm) containers have been validated for a combined maximum load of 25lbs. with up to two internal stacked baskets and up to two silicon mats (one mat per basket) for the Full-Size, Mid-Size and Half-Size containers. Both solid and perforated bottom containers, maximum depth 150mm/each, can be stacked a maximum of 3 containers high during sterilization.
Sterilized devices may be stored and transported within the container. The container is intended to maintain sterility of the contents for up to six (6) months.
Device Description
The SklarLite" Rigid Sterilization Container System consists of a family of rigid, re-usable, stackable, sealed containers that provide an effective sterilization packaging method for medical devices. Container bottoms and lids, within a given size, are interchangeable. Containers can be fitted with safety lids, protecting filters during storage and/or transport. The system consists of the following components:
- Container bottoms (both perforated and non-perforated versions) .
- Container lids (both perforated and non-perforated_versions)_ .
- Container baskets .
- Container labels .
- Disposable filters .
The container system is designed for sterilant penetration through perforations in the lid and container bottom models that are perforated. Containers are offered in six colors. Filter media and sterilization indicator cards should be used in conjunction with the containers. Containers are protected by disposable plastic security seals.
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K Number
K082479Device Name
SKLAR SURGICAL GOWN
Manufacturer
SKLAR CORP.
Date Cleared
2009-04-24
(239 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
SKLAR CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sklar Surgical Gown is a single use, sterile or non-sterile item that is intended to be used in the operating room to be a protective covering, for operating room staff, from the transfer of body fluids and particulates.
The Sklar Surgical Gown is a disposable item that is intended to be used in the operating room as a protective covering, for operating room staff, from the transfer of body fluids and particulates.
The Sklar Surgical Gown is provided as sterile and non-sterile.
Sterile gowns are to be sold directly to users following EtO sterilization validation according to ISO 11135-1:2007. Non-sterile gowns are to be sold to OEMs for EtO sterilization according to ISO 11135-1:2007.
Device Description
The Sklar Surgical Gown is an open back gown manufactured from a non-woven fabric. The non-woven fabric is a polypropylene spunbond meltblown and the fibers are mechanically bonded together. The Surgical Gown comes in various sizes without any areas of reinforcement. The Surgical Gowns are supplied sterile and non-sterile, for single use only.
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