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.

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

AI/ML Overview

This document describes the 510(k) submission for Exact Medical Manufacturing's Surgical Gowns – Spunlace w/PE Layer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of an AI-based device. Therefore, many of the requested categories related to AI device evaluation (e.g., AI integration, multi-reader multi-case studies, training set details) are not applicable.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from "met acceptance criteria")	Reported Device Performance
Barrier Properties	Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards.	"All results of the testing met acceptance criteria."
Tensile Strength	Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards.	"All results of the testing met acceptance criteria."
Tear Strength	Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards.	"All results of the testing met acceptance criteria."
Flammability	Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards. (Typically per 16 CFR Part 1610 for apparel textiles.)	"All results of the testing met acceptance criteria."
Linting	Equivalent to the predicate device (Medline (Proxima) Surgical Gowns K964142) as per relevant standards.	"All results of the testing met acceptance criteria."
Sterility	Achieves sterility through Ethylene Oxide (ETO) process meeting AAMI 11135-1:2007 (Sterilization of Healthcare Products) with specific parameters: - Pre-Conditioning: Temperature = 42°C, RH = 60%, Dwell Time = 6 hours - EO Cycle: Temperature = 54°C, RH >= 30%, EO Concentration = 730mg/m3, Dwell Time = 9 hours - Aeration: Temperature = ambient, Time >= 72 hours - EO Residuals: EO <= 4mg max., ECH <= 9mg max.	"All results of the testing met acceptance criteria." (Specific to sterility, this would mean the ETO process outlined achieves the defined sterility assurance level and residual limits.)
Biocompatibility	Meets the methods of ISO 10993 for Cytotoxicity, Irritation, and Sensitization.	"All results of the testing met acceptance criteria."

Study Proving Device Meets Acceptance Criteria:

The document describes "Non-clinical performance testing" that was conducted to demonstrate substantial equivalence to the predicate device (Medline (Proxima) Surgical Gowns 510(k)964142).

Study Design: This was a series of in-vitro and laboratory tests designed to evaluate the physical properties, barrier performance, biocompatibility, and sterilization effectiveness of the new surgical gown. It's a non-clinical, comparative study against established standards and the characteristics of the predicate device.
Conclusion: "All results of the testing met acceptance criteria." and the gowns are deemed "substantially equivalent in all specifications and performance compared to the predicate device... and do not present any differences that could raise concerns related safety and effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for each test. The wording "All results of the testing met acceptance criteria" suggests that a sufficient number of samples were tested for each performance characteristic to demonstrate compliance with the relevant standards.
Data Provenance: Not specified. It's reasonable to assume the testing was conducted in a laboratory setting, likely in the US, given the submission to the FDA. The data would be prospective in nature for these performance tests (i.e., new tests performed on newly manufactured devices or materials).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is not an AI/diagnostic device that requires expert ground truth for image interpretation or similar tasks. The "ground truth" here is defined by established international and national performance standards (e.g., ISO 10993 for biocompatibility, AAMI 11135-1:2007 for sterilization, and likely ASTM or AAMI standards for physical properties and barrier performance).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As this is not an AI/diagnostic device, there is no expert adjudication process for results. Performance is assessed against quantitative and qualitative standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI-assisted diagnostic or interpretation device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device (surgical gown), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance tests consists of established industry, national, and international standards for medical device performance, material properties, biocompatibility, and sterilization. For example:
- Physicochemical tests: Standards like ASTM for tensile/tear strength, AAMI for barrier properties.
- Biocompatibility: ISO 10993 series.
- Sterilization: AAMI 11135-1:2007.
- The predicate device's performance also serves as a comparator for demonstrating substantial equivalence.

8. The sample size for the training set

Not Applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI device that requires a training set or its associated ground truth establishment.

Summary

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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

100

Date Summary was Prepared	June 1, 2011
510(k) Submitter	David Nowicki, PresidentExact Medical Manufacturing Inc.4917 William StreetLancaster, NY 14043dnowicki@exactmm.com(p)716-681-0866, (f) 716-681-4110
Primary Contact for this 510(k)Submission	David Nowicki, PresidentExact Medical Manufacturing Inc.4917 William StreetLancaster, NY 14043dnowicki@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 andClassification 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 gownsusing in the OR as a protective covering, for the operating room staff, from the transfer ofmicroorganisms, body fluids and particulates. Exact Medical Manufacturing Surgical Gowns-Spunlace w/PE Layer are comprised of disposable nonwoven (Spunlace), 100% polyestercuffs, 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 ManufacturingSurgical Gown - Spunlace w/PE Layer are sterile or non-sterile single use devices that are intended to beworn by operating room personnel during surgical procedures to protect both the surgical patient and theoperating 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 oxidesterilization.
	Sterilization method: ETO (ethylene oxide)Standard: AAMI 11135-1:2007, Sterilization of Healthcare ProductsPre-Conditioning: Temperature C o = 42RH% = 60Dwell Time Hours = 6EO Cycle: Temperature C o = 54RH% =/> 30EO Concentration = 730mg/m3Dwell Time Hours = 9Aeration: Temperature = ambientTime =/> 72 hoursEO 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 equivalentand 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 ISO10993, Barrier properties, tensile, tear strength, flammability, linting and sterility. All results ofthe testing met acceptance criteria.
Substantial EquivalenceConclusion	The surgical gowns described in this 510(k) submission are substantially equivalent in allspecifications and performance compared to the predicate device indentified in K964142 anddo not present any differences that could raise concerns related safety and effectiveness.

4917 William Street - Suite C ・ Lancaster, NY 14086 ・ (716) 681-0866

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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.

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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

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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.

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

Regulation Number and Section

§ 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.