(239 days)
Not Found
No
The device description and intended use clearly describe a physical surgical gown, with no mention of software, algorithms, or any technology that would incorporate AI or ML.
No
The device is a surgical gown intended for protective covering for operating room staff, not for treating or diagnosing any medical condition.
No
Explanation: The "Intended Use / Indications for Use" section clearly states that the Sklar Surgical Gown is a "protective covering" for operating room staff to prevent the transfer of body fluids and particulates. It does not mention diagnosis, disease detection, or any diagnostic capabilities.
No
The device description clearly indicates it is a physical surgical gown made from non-woven fabric, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: An In Vitro Diagnostic device is a medical device that is intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Intended Use of the Sklar Surgical Gown: The intended use of the Sklar Surgical Gown is clearly stated as a "protective covering, for operating room staff, from the transfer of body fluids and particulates." It is a barrier device used on the outside of the body to protect the user.
- No Specimen Examination: The description and intended use do not involve the examination of any human specimens.
Therefore, based on the provided information, the Sklar Surgical Gown is a medical device, but it falls under a different category than In Vitro Diagnostics. It is a protective barrier device used in a clinical setting.
N/A
Intended Use / Indications for 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.
Product codes
FYA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room staff / operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Sklar Corporation
889 South Matlack Street
West Chester, РА 19382
Phone: 610-430-3200
Toll Free: 800-221-2166
Fax: 610-350-0583
www.sklarcorp.com
08.0479
510(k) Pre-Market Notification Sklar Surgical Gown
APR 2 4 2009
EXHIBIT 1
510(K) SUMMARY
1. Submitted By:
Michelle Wirtner, General Counsel Sklar Corporation (d/b/a Sklar Instruments) 889 South Matlack Street West Chester, PA 19382 Tel: 800-221-2166 Fax: 610-350-0583
Date Submitted: 8/25/08
2. Device Names: Trade/Proprietary Name: Sklar Surgical Gown
Common Name: Surgical gown
Classification: Class II, 21 CFR 878.4040 Product Code: FYA (Surgical Apparel)
3. Predicate Device Information:
Welmed Inc. Surgical Gowns - K070431
4. 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.
ડ. Indications for 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.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2009
Sklar Corporation C/o Ms. Natalya Valerio Mdi Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K082479
Trade/Device Name: Sklar General Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 14, 2009 Received: April 15, 2009
Dear Ms. Valerio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration
2
Page 2- Ms. Valerio
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Exhibit #5
FDA 510(k) Pre-Market Notification Sklar Surgical Gown
Page
Indications for Use
510(k) Number (if known): . .
Device Name: Sklar General Surgical Gown
Indications For Use:
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.
Prescription Use (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swarikar
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KC824