These gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non-protective . They are not intended for use in the operating room.

Device Description

SafeCare® Open Back Protective Gowns (Models: 46969-097X, 46969097XB, 46969097X-10, 46969-098 & 46969-098D) and ValueCare® Open Back (Model: 4550-25X) Protective Gowns are open back gowns made from extruded plastic film.

The SafeCare® and ValueCare® Open Back Protective gowns provide barrier protection to the wearer from body fluids and particulate materials and have passed barrier testing according to ANSI/AAMI PB70:2012 Level 3 protection or equivalent.

The significant design points of the gowns are:

Made from extruded plastic film to provide an effective barrier meeting the requirements for penetration testing as per ANSI/AAMI PB70: 2012 Level 3 according to AATCC 42:2013 and AATCC 127:2014 test methods.
Backless to provide comfort
Thumb loops at the wrist which help to hold gown sleeves down
Back has perforations so the gowns can be removed without taking over the head in case they are contaminated

AI/ML Overview

The provided text describes information about the substantial equivalence of SafeCare® Open Back Protective Gowns and ValueCare® Open Back Protective Gowns to a predicate device, the Poly-Med Disposable Personal Protective Gown Apron. The information focuses on design, materials, indications for use, labeling, and various performance tests to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided text, noting where specific details are not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each test in a numerical or pass/fail threshold. Instead, it states that the device "meets" certain levels or is "non-irritating," "non-sensitizing," etc. The table below synthesizes the test results for the subject devices (SafeCare® and ValueCare® Open Back Protective Gowns) against relevant standards, effectively serving as the reported device performance. The "Acceptance Criteria" column reflects the standard or outcome deemed acceptable.

Acceptance Criteria (Standard/Requirement)	Reported Device Performance (SafeCare® & ValueCare® Open Back Protective Gowns)
Dermal Irritation Test: ISO 10993-10:2010 Skin Irritation	The subject device is non-irritating.
Dermal Sensitization Test: ISO 10993-10:2010 Skin Sensitization	The subject device is non-sensitizing.
Cytotoxicity Test: ISO 10993-5:2009 In Vitro Cytotoxicity	The device extract did not show potential toxicity to L-929 cells.
Flammability Test: 16 CFR Part 1610 (Class 1 "normal flammability")	Meets Class 1 "normal flammability" in accordance with 16 CFR Part 1610.
Fluid Penetration Test: ANSI/AAMI PB70:2012 Level 3 (AATCC 127:2014 Hydrostatic Pressure Test & AATCC 42:2013 Impact Penetration Test)	Successfully tested and meets the Level 3 requirements of the ANSI/AAMI PB70:2012 liquid barrier classifications.
Sterility	Provided non-sterile.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample sizes used for any of the tests (e.g., dermal irritation, sensitization, cytotoxicity, flammability, fluid penetration).

Regarding data provenance, the studies were conducted to support the 510(k) submission for BAM Corporation Limited, Hong Kong, China. The text does not explicitly state whether the studies were retrospective or prospective, but clinical trials are not mentioned, suggesting these are likely laboratory-based performance tests performed on the device itself.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to this submission. The tests conducted are laboratory-based performance tests (e.g., biocompatibility and barrier testing) against established standards and test methods. They do not involve expert interpretation or ground truth establishment in the way clinical studies or diagnostic imaging studies would.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or assessments. As this submission describes laboratory performance tests, an adjudication method is not applicable.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This submission is for protective gowns and involves laboratory performance testing, not an AI-assisted diagnostic or interpretive device involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a protective gown, not an algorithm or software. The performance tests are for the physical properties of the gown.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the performance tests described, the "ground truth" is established by adherence to recognized international and national standards and test methods. For example:

Biocompatibility (Dermal Irritation, Sensitization, Cytotoxicity): Ground truth is determined by the criteria and pass/fail results defined within ISO 10993-10:2010 and ISO 10993-5:2009.
Flammability: Ground truth is defined by the success criteria outlined in 16 CFR Part 1610 (meeting Class 1).
Fluid Penetration: Ground truth is the successful adherence to the Level 3 requirements of ANSI/AAMI PB70:2012, as measured by AATCC 127:2014 and AATCC 42:2013.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are used for machine learning algorithms. The device described, protective gowns, does not involve such algorithms. The tests performed are physical and biological property assessments of the manufactured product.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 8, 2021

BAM Corporation Limited Mary Mejaes Official Correspondent No. 138 Shatin Rural Committee Road, Shatin, N.t. Unit 1706, Tower 2, Grand Central Plaza Hong Kong, N.T. China

Re: K160337

Trade/Device Name: Safecare Open Back Protective Gowns ValueCare Open Back Protective Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: QPC

Dear Mary Mejaes:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 7, 2017. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Ryan Ortega, Acting Assistant Director, Office of Surgical and Infection Control Devices, at 240-402-2303 or Ryan.ortega@fda.hhs.gov.

Sincerely,

Bifeng Qian -S

For Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

July 7, 2017

BAM Corporation Limited Mary Mejaes Official Correspondent No. 138 Shatin Rural Committee Road, Shatin, N.T. Unit 1706, Tower 2, Grand Central Plaza Hong Kong, CN

Re: K160337

Trade/Device Name: SafeCare Open Back Protective Gowns ValueCare Open Back Protective Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: June 20, 2017 Received: June 27, 2017

Dear Mary Mejaes:

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 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

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the quality systems (OS) 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,

Mark S. Fellman -S

for

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160337

Device Name ValueCare® Open Back Protective Gowns

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K160337

Device Name SafeCare® Open Back Protective Gowns

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k)Summary

K160337

Regulatory Affairs Contact:	Ms. Mary MejaesBAM Corporation Ltd.Unit P, 12/F, Kings Wing Plaza 1No. 3 On Kwan StreetShek Mun, Shatin, N.T.Hong Kong
Telephone:	(011) 852-3695-5272
Fax:	(011) 852-2314-1317
Email:	mary@bam-corp.com
Date Summary Prepared:	July 3, 2017
Common Name:	Single Use/Non-Sterile Open Back Protective Gowns
Classification Name:	Surgical Isolation Gowns,Class II, 21 CFR 878: 4040, Product Code : FYC
Proprietary Name:	SafeCare® Open Back Protective GownsValueCare® Open Back Protective Gowns
Device Description:	SafeCare® Open Back Protective Gowns (Models: 46969-097X,46969097XB, 46969097X-10, 46969-098 & 46969-098D) and ValueCare®Open Back (Model: 4550-25X) Protective Gowns are open back gownsmade from extruded plastic film.The SafeCare® and ValueCare® Open Back Protective gowns provide barrierprotection to the wearer from body fluids and particulate materials andhave passed barrier testing according to ANSI/AAMI PB70:2012 Level 3protection or equivalent.
	The significant design points of the gowns are:1. Made from extruded plastic film to provide an effective barrier meetingthe requirements for penetration testing as per ANSI/AAMI PB70: 2012Level 3 according to AATCC 42:2013 and AATCC 127:2014 test methods.2. Backless to provide comfort3. Thumb loops at the wrist which help to hold gown sleeves down4. Back has perforations so the gowns can be removed without takingover the head in case they are contaminated
Predicate Device:	Poly-Med Disposable Personal Protective Gown Apron, 510(k) K925077
	510(k)SummaryPage 1 out of 4

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Indications for Use: These gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non-protective. They are not intended for use in the operating room.

Aspect	Subject Device:ValueCare® Open BackProtective Gowns510K No: K160337	Subject Device:SafeCare® Open BackProtective Gowns510K No: K160337	Predicate Device:PolyMed DisposablePersonal Protective GownApron510K No: K925077
Design	Design includes open back, thumb loops, backperforation for easyremoval and waist tie	Design includes open back, thumb loops, backperforation for easyremoval and waist tie	Design includes open back, thumb loops, backperforation for easyremoval and waist tie
Material	Made from extrudedplastic film.	Made from extrudedplastic film.	Made from extrudedplastic film.
Material Color	Blue	Blue or Yellow	Blue, Red, Pink, White,Yellow
Indications for Use	These gowns are intendedto protect health carepatients and health carepersonnel from thetransfer of micro-organisms, body fluids andparticulate material. Theback of the gown is openand non- protective. Theyare not intended for use inthe operating room.	These gowns are intendedto protect health carepatients and health carepersonnel from thetransfer of micro-organisms, body fluids andparticulate material. Theback of the gown is openand non- protective. Theyare not intended for use inthe operating room.	Designed for use inhealthcare to provideliquid and aerosolresistance.
Labeling Claims	These gowns are intendedto protect health carepatients and health carepersonnel from thetransfer of micro-organisms, body fluids andparticulate material. Theback of the gown is openand non- protective. Theyare not intended for use inthe operating room.* Non-Sterile	These gowns are intendedto protect health carepatients and health carepersonnel from thetransfer of micro-organisms, body fluids andparticulate material. Theback of the gown is openand non- protective. Theyare not intended for use inthe operating room.* Non-Sterile	In compliance with OSHABloodborne PathogenStandard, 29, CFR Part1910.1030.Provides liquid andaerosol blood resistance.
	* Not Made withNatural Rubber Latex* Meets ANSI/AAMIPB70: 2012 Level 3* Open Back Non-protective* Single Use, Disposable	* Not Made withNatural Rubber Latex* Meets ANSI/AAMIPB70: 2012 Level 3* Open Back Non-protective* Single Use, Disposable	Not provided
Biocompatibility -Sensitization andIrritation	Under the condition of thestudies:ISO 10993-10:2010, thedevice is non-irritating andnon- sensitizing	Under the condition of thestudies:ISO 10993-10:2010, thedevice is non-irritating andnon- sensitizing	Not provided
Biocompatibility-Cytotoxicity	Under the condition of thestudies:ISO10993-5:2009,The test device extract didnot show potential toxicityto L-929 cells	Under the condition of thestudies:ISO 10993-5:2009,The test device extract didnot show potential toxicityto L-929 cells	Not provided
Barrier Testing	ANSI/AAMI PB70: 2012Level 3:AATCC 127:2014Hydrostatic Pressure TestAATCC 42:2013 ImpactPenetration Test	ANSI/AAMI PB70: 2012Level 3:AATCC 127:2014Hydrostatic Pressure TestAATCC 42:2013 ImpactPenetration Test	Not provided
Flammability	Meets Class 1 "normalflammability " inaccordance to 16 CFR Part1610	Meets Class 1 "normalflammability " inaccordance to 16 CFR Part1610	Not provided
Sterility	Provided non-sterile	Provided Non-sterile	Provided Non-sterile

Comparison of Subject and Predicate Devices:

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Summary of the technological characteristics of the device compared to the Predicate Device:

The PolyMed Disposable Personal Protective Gown Apron 510(k) K925077 and the SafeCare® Open Back Protective Gowns and ValueCare® Open Back Protective Gowns 510(k) K160337 are both made from extruded Plastic Film material.
The construction and design features which include an open back, thumb loops, heat sealed sleeve seams and perforated back for easy removal are found in both gowns.
Both the subject and predicate device are being promoted as suitable to be worn by health care professionals as barrier protection.
Neither gown is intended to be used for surgical procedures and both are provided non-sterile.

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The SafeCare® and ValueCare® Open Back Protective Gowns are substantially equivalent to the ● PolyMed Disposable Personal Protective Gown Apron in that they both provide the following characteristics: fluid barrier and tensile strength.

Test Performed	Test Standard	Results
Dermal Irritation Test	ISO 10993-10:2010 SkinIrritation	Under the conditions of the studies: ISO 10993-10:2010, the subject device is non-irritating.
Dermal SensitizationTest	ISO 10993-10:2010 SkinSensitization	Under the conditions of the studies: ISO 10993-10:2010, the subject device is non-sensitizing.
Cytotoxicity Test	ISO 10993-5:2009 In VitroCytotoxicity	Under the conditions of the studies: ISO 10993-5:2009, the SafeCare® Open Back ProtectiveGowns and ValueCare® Open Back ProtectiveGowns extract did not show potential toxicityto L-929 cells.
Flammability Test	16 CFR Part 1610	Subject Device meets Class 1 requirements perNFPA 16 CFR Part 1610
Fluid Penetration Test	ANSI/AAMI PB70:2012AATCC 127:2014Hydrostatic Pressure Testand AATCC 42:2013 ImpactPenetration test	SafeCare® Open Back Protective Gowns andValueCare® Open Back Protective Gowns havebeen successfully tested and meet the Level 3requirements of the ANSI/AAMI PB70:2012Liquid Barrier classifications.

Summary of Testing:

Conclusion:

Based on the results of biocompatibility testing, physical performance testing, and intended use the subject devices are as safe and as effective and perform as well as the predicate device. The SafeCare® and ValueCare® Open Back Protective Gowns are substantially equivalent to the predicate device cleared under K925077.

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.