(85 days)
Not Found
No
The 510(k) summary describes a surgical gown and does not mention any AI or ML technology. The device description and performance studies focus on material properties and barrier protection.
No
Surgical gowns are protective coverings for operating room staff, not devices intended to treat or diagnose a disease or condition.
No
Explanation: The device is a surgical gown, intended to protect from microorganisms and fluids. It does not perform any diagnostic function.
No
The device description clearly states it is a physical surgical gown made of materials like spunlace, polyester, and polyethylene, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical gown is for protecting operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties and materials of the gown (nonwoven, polyester cuffs, Velcro closure, reinforced areas). There is no mention of components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
In summary, the Exact Medical Manufacturing Surgical Gown is a medical device intended for barrier protection during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Device Name: Exact Medical Manufacturing Surgical Gowns-Spunlace w/PE Layer Model Numbers 18-201L, 18-201-XL, 18-201 XXL and 18-201 XLXL Indications for Use: Exact Medical Manufacturing Surgical Gown - Spunlace w/PE Layer are sterile 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.
Product codes
FYA
Device Description
Exact Medical Manufacturing Surgical Gown-SPL are single use, disposable surgical gowns using in the OR as a protective covering, for the operating room staff, from the transfer of microorganisms, body fluids and particulates. Exact Medical Manufacturing Surgical Gowns- Spunlace w/PE Layer are comprised of disposable nonwoven (Spunlace), 100% polyester cuffs, Velcro neck closure, reinforced areas fabric or polyethylene
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)
Exact Medical Manufacturing Surgical Gowns-Spunlace w/PE Layer is substantially equivalent and meets the same acceptance criteria as the predicate device/gown in K964142. Non-clinical performance testing includes: Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO 10993, Barrier properties, 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)
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.
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Image /page/0/Picture/0 description: The image contains the logo for EMM Exact Medical Manufacturing, Inc. The logo consists of a geometric design on the left and the text "EMM Exact Medical Manufacturing, Inc." on the right. The text is in a simple, sans-serif font, with "EMM" in a larger, bolder font than the rest of the text. The geometric design is made up of small squares.
Sec. 6: 510(k) Summary – Surgical Gown-Spunlace w/PE Layer, rev. 072511
510(k) Summary for Exact Medical Manufacturing Inc., Surgical Gowns – Spunlace w/PE Layer
T
100
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| Date Summary was Prepared | June 1, 2011 |
|---|---|
| 510(k) Submitter | David Nowicki, President |
| Exact Medical Manufacturing Inc. | |
| 4917 William Street | |
| Lancaster, NY 14043 | |
| dnowicki@exactmm.com | |
| (p)716-681-0866, (f) 716-681-4110 | |
| Primary Contact for this 510(k) | |
| Submission | David Nowicki, President |
| Exact Medical Manufacturing Inc. | |
| 4917 William Street | |
| Lancaster, NY 14043 | |
| dnowicki@exactmm.com | |
| (p)716-681-0866, (f) 716-681-4110 | |
| Device Common Name | Surgical Gown |
| Trade Name | Surgical Gown - Spunlace w/PE Layer |
| Device Product Codes and | |
| Classification Name | FYA, 21CFR878.4040, Surgical Apparel, Class II |
| Predicate Device | Medline (Proxima) Surgical Gowns 510(k)964142 |
| Device Description | Exact Medical Manufacturing Surgical Gown-SPL are single use, disposable surgical gowns |
| using in the OR as a protective covering, for the operating room staff, from the transfer of | |
| microorganisms, body fluids and particulates. Exact Medical Manufacturing Surgical Gowns- | |
| Spunlace w/PE Layer are comprised of disposable nonwoven (Spunlace), 100% polyester | |
| cuffs, Velcro neck closure, reinforced areas fabric or polyethylene | |
| Intended Use | Device Name: Exact Medical Manufacturing Surgical Gowns-Spunlace w/PE Layer Model Numbers 18- |
| 201L, 18-201-XL, 18-201 XXL and 18-201 XLXL Indications for Use: Exact Medical Manufacturing | |
| Surgical Gown - Spunlace w/PE Layer are sterile or non-sterile 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 - Spunlace w/PE Layer are also sold as bulk non- | |
| sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide | |
| sterilization. | |
| Sterilization method: ETO (ethylene oxide) | |
| Standard: AAMI 11135-1:2007, Sterilization of Healthcare Products | |
| Pre-Conditioning: Temperature C o = 42 | |
| RH% = 60 | |
| Dwell Time Hours = 6 | |
| EO Cycle: Temperature C o = 54 | |
| RH% =/> 30 | |
| EO Concentration = 730mg/m3 | |
| Dwell Time Hours = 9 | |
| Aeration: Temperature = ambient | |
| Time =/> 72 hours | |
| EO Residuals; EO=4mg max., ECH=9mg. max. | |
| Technological Characteristics | Exact Medical Manufacturing Surgical Gowns-Spunlace w/PE Layer have the same design, |
| material and performance characteristics of the predicate device. | |
| Summary of Testing | Exact Medical Manufacturing Surgical Gowns-Spunlace w/PE Layer is substantially equivalent |
| and meets the same acceptance criteria as the predicate device/gown in K964142. Non- | |
| clinical performance testing includes: | |
| Biocompatibility (cytotoxicity, irritation, sensitization) in compliance with the methods of ISO | |
| 10993, Barrier properties, tensile, tear strength, flammability, linting and sterility. All results of | |
| the testing met acceptance criteria. | |
| Substantial Equivalence | |
| Conclusion | The surgical gowns described in this 510(k) submission are substantially equivalent in all |
| specifications and performance compared to the predicate device indentified in K964142 and | |
| do not present any differences that could raise concerns related safety and effectiveness. |
4917 William Street - Suite C ・ Lancaster, NY 14086 ・ (716) 681-0866
··
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Exact Medical Manufacturing, Inc. % Mr. Robert O. Dean President Compliance Systems International, LLC. 1083 Delaware Avenue Buffalo, NY 14209
AUG 26 2011
Re: K111535
RT11955
Trade/Device Name: EMM Surgical Gowns-Spunlace w/PE Layer ade/Device Name: Linner 2011 XL, 18-201 XXL, and 18-201 XLXL Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA Dated: July 28, 2011 Received: August 1, 2011
Dear Mr. Dean:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(x) promised is substantially equivalent (for the referenced above and have determined the accession marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed in of the Medical D indications for use stated in the cholosation to readers of the Medical Device interstate commerce prior to Niay 20, 1 70, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 Amendments, or to uevices that have been to the do not require approval of a prematice the Federal Food, Drug, and Cosment Act (710) that sket the device, subject to the general
approval application (PMA). You may, therefore, market the Aet include approval application (1 MA). Tou may, more of controls provisions of the Act include confors provisions of the Act. "The genting of devices, good manufacturing practice, requirements for annual registration, insting and adulteration. Please note: CDRH does labeling, and promotions against insoftanting 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 If your device is classifica (see above) into child in the regulations affecting your (PMA), It may be subject to adultions, Title 21, Parts 800 to 898. In the Feder device can be found in the Code of Poderal Regulations, wour device in the Federal Register.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issuance of a suscises with other requirements
mean that FDA has made a determination that your devices with other Federal agencies. mean that FDA has made a delemination that your administered by other Federal agencies.
of the Act or any Federal statutes and regulations a byt not limited to: registration of the Act or any Federal statues and reguirements, including, but not limited to: registration
You must comply with all the Act's requirements, and not device reporting You must comply with an the Act s requirements, most 801); medical device reporting and listing (21 CFK Part 807), laoching (21 CFR 803); good manufacturing
(reporting of medical device-related adverse events) (21 CFR 803); goverlight (21 CFR Part 82 (reporting of medical device-lefated adverse verse) (D) regulation (21 CFR Part 820);
practice requirements as set forth in the quality systems (QS) regulations 531-542 of practice requirements as set form in the quality systems (@) . . .
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), If you desire specific advice for your actives of these Offices/CDRH/CDRHOffices
please go to http://www.fda.gov/AboutFDA/Centers@ffices/CDRH's) ( please go to http://www.ida.gov/A00an Drives and Radiological Health's (CDRH's) Office of
/ucm115809.htm for the Center for Devices and Radios by reference to /ucm113809.mill for the Center 101 DOYlots a mixtled, "Misbranding by reference to Compliance. "Also, please note the regardions regarding the reporting the reporting of
premarket notification" (21CFR Part 807.97). For questions regarding of premarket nothlication (21CFR Part 800), (21 CFR Part 803), please go to adverse events under the MDR regulation (21 Or KaProblem/default.htm for the CDRH's
http://www.fda.gov/MedicalDevices/Safety/Reportaliance http://www.lua.gov/Medical/Devision of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general intonnational on 9 and Consumer Assistance at its toll-free
Division of Small Manufacturers, International and Consumer Assistance at its toll-fr DIVIsion of Sinan Manufacturers. 11, 2019 796-7100 or at its Internet address
number (800) 638-2041 or (301) 796-7100 or at its Internet start defentlation number (800) 038-2041 01 (2017) 790 1700 views for You/Industry/default.htm.
incerely yours,
F. Swart-Tuorinen
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
Sec. 7: Intended Use, rev.072511
Indications for Use Form
Indications for Use:
510(k) Number (if known): K111535
Device Name: Exact Medical Manufacturing Surgical Gowns-Spunlace w/PE Layer Model Numbers 18-201L, 18-201-XL, 18-201 XXL and 18-201 XLXL Indications for Use: Exact Medical Manufacturing Surgical Gown - Spunlace w/PE Layer are sterile 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 - Sounlace w/PE Laver are also sold as built nonsterile, single use items, to repackagerrelabeler establishments for further packaging and ethylene oxide sterilization.
Sterilization method: ETO (ethylene oxide) Standard: AAMI 11135-1:2007, Sterilization of Healthcare Products Pre-Conditioning: Temperature C = 42 . -RH% = 60 Dwell Time Hours = 6 EO Cycle: Temperature C° = 54 RH% =/> 30 EO Concentration = 730mg/m3 Dwell Time Hours = 9 Aeration: Temperature = ambient Time =/> 72 hours EO Residuals; EO=4mg max., ECH=9mg. max.
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)
Susa Pease
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111535