K Number
K101593
Device Name
EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL
Date Cleared
2010-09-03

(87 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are sterile or nonsterile single use 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. The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization
Device Description
Exact Medical Manufacturing Surgical Gown SMS w/PE Layer has the same design, material and performance characteristics of the predicate device.
More Information

Not Found

No
The device is a surgical gown, and the description focuses on material properties and barrier performance, with no mention of AI/ML or related concepts.

No
The device is a surgical gown intended to protect personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. It does not actively treat or diagnose a disease or condition.

No
Explanation: The device is a surgical gown intended to protect against transfer of microorganisms and body fluids, not to diagnose a medical condition.

No

The device description clearly indicates it is a physical surgical gown made of SMS with a PE layer, not software. The performance studies also focus on physical properties and barrier performance.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is a surgical gown worn by operating room personnel to protect against the transfer of microorganisms, body fluids, and particulate material. This is a barrier protection function, not a diagnostic function performed in vitro (outside the body).
  • Device Description: The description focuses on the physical characteristics and performance of a surgical gown.
  • Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.

IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This surgical gown does not fit that description.

N/A

Intended Use / Indications for Use

Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are sterile or nonsterile single use 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.

The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Product codes

FYA

Device Description

Exact Medical Manufacturing Surgical Gown SMS w/PE Layer has the same design, material and performance characteristics of the predicate device.

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 personnel / 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)

Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties- AAMI PB:70 Level 3, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K023117

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

Image /page/0/Picture/0 description: The image shows the logo for Exact Medical Manufacturing, Inc. The logo consists of the letters "EMM" in bold, black font, with the company name written in a smaller font size underneath. To the left of the text is a geometric design that is partially shaded.

101593

эс. 6: 510(k) Summary -- EMM Surgical Gown SMS w/PE Layer

.Page

Technological Characteristics Exact Medical Manufacturing Surgical Gown SMS w/PE Layer has the same design, material and performance characteristics of the predicate device. Summary of Testing Exact Medical Manufacturing Surgical Gown SMS w/PE Layer is substantially equivalent and meets the same acceptance criteria as the predicate device/gown in K023117. Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties- AAMI PB:70 Level 3, tensile, tear strength, flammability, linting and sterility. All results of the testing met acceptance criteria. Substantial Equivalence The surgical gowns described in this 510(k) submission are substantially equivalent in all specifications and performance compared to the predicate device indentified in K023117.

1

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract human form or a caduceus, rendered in black.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. David Nowicki President Exact Medical Manufacturing, Incorporated 4917 William Street. Suite C Lancaster, New York 14186

2010 SEE 3

Re: K101593

Trade/Device Name: Exact Medical Manufacturing Surgical Gowns SMS w/PE Layer Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: June 4, 2010 Received: June 8, 2010

Dear Mr. Nowicki:

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.

2

Page 2- Mr. Nowicki

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 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony D. West

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

3

SEP 3 2010

K101593

Page 26

Indications for Use Form

Indications for Use:

510(k) Number (if known):

Device Name: Exact Medical Manufacturing Surgical Gown SMS w/PE Layer

Indications for Use: Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are sterile or nonsterile single use 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.

The Exact Medical Manufacturing Surgical Gown SMS w/PE Layer are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

الماركة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة الم

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Provinsion of Anesthesional Payines Division Control, Dental Devices

510(k) Number. K101593