(416 days)
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No
The 510(k) summary describes a reusable surgical gown and its sterilization parameters. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
A surgical gown is a protective barrier, not a device designed to treat or alleviate a medical condition. Its purpose is to prevent the transfer of contaminants, which is a preventive measure rather than a therapeutic one.
No
Explanation: The device is a surgical gown intended for protection during procedures, not for diagnosis.
No
The device description clearly identifies the device as a "reusable surgical gown," which is a physical garment and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect operating room personnel and patients from the transfer of micro-organisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic one.
- Device Description: The description details a reusable surgical gown and its sterilization parameters. This aligns with personal protective equipment used in a clinical setting, not a device used to perform tests on samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This surgical gown does not fit that description.
N/A
Intended Use / Indications for Use
The Blockade reusable surgical gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material.
Product codes
FYA
Device Description
The Blockade reusable surgical gown is provided non-sterile. Sterilization parameters are as follows:
- Prevac Steam Sterilization 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)
Medline Item Numbers / gown color / lig. barrier protection / gown size
| MDTGBS3CL | / Ceil | / AAMI Level 3 | / Large |
|---|---|---|---|
| MDTGBS3CXL | / Ceil | / AAMI Level 3 | / X-Large |
| MDTGBS3C2X | / Ceil | / AAMI Level 3 | / XX-Large |
| MDTGBS3JL | / Jade | / AAMI Level 3 | / Large |
| MDTGBS3JXL | / Jade | / AAMI Level 3 | / X-Large |
| MDTGBS3J2X | / Jade | / AAMI Level 3 | / XX-Large |
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
operating room personnel / Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
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Reference Device(s)
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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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2016
Medline Industries, Inc. Ms. Pauline Maralit Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060
Re: K150598
Trade/Device Name: Blockade Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: April 15, 2016 Received: April 19, 2016
Dear Ms. Maralit,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
Page 2 - Ms. Maralit
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150598
Device Name Blockade Surgical Gown
Indications for Use (Describe)
The Blockade reusable surgical gown is intended to be used by operating room personnel during surgical procedures to help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate material.
- The Blockade reusable surgical gown is provided non-sterile. Sterilization parameters are as follows:
-
- Prevac Steam Sterilization 135°C/274°F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)
Medline Item Numbers / gown color / lig. barrier protection / gown size
| MDTGBS3CL | / Ceil | / AAMI Level 3 | / Large |
|---|---|---|---|
| MDTGBS3CXL | / Ceil | / AAMI Level 3 | / X-Large |
| MDTGBS3C2X | / Ceil | / AAMI Level 3 | / XX-Large |
| MDTGBS3JL | / Jade | / AAMI Level 3 | / Large |
| MDTGBS3JXL | / Jade | / AAMI Level 3 | / X-Large |
| MDTGBS3J2X | / Jade | / AAMI Level 3 | / XX-Large |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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