What is the regulatory pathway for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

Poly-Med Disposable Personal Protective Gown Apron (K925077).

Who can help prepare an FDA 510(k) submission like Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns

Q: Who is the manufacturer of Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

Bam Corporation Limited filed the 510(k) submission for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns (K160337).

Q: What is the FDA product code for Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns?

QPC. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

K160337 · Bam Corporation Limited · QPC · Jul 7, 2017 · General, Plastic Surgery

Device Facts

Record ID	K160337
Device Name	Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns
Applicant	Bam Corporation Limited
Product Code	QPC · General, Plastic Surgery
Decision Date	Jul 7, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended 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.

Device Story

Single-use, non-sterile, open-back protective gowns; manufactured from extruded plastic film. Features include thumb loops for sleeve retention and back perforations for rapid removal if contaminated. Used by healthcare personnel to provide barrier protection against body fluids and particulates. Not intended for operating room use. Provides Level 3 barrier protection per ANSI/AAMI PB70:2012.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-10:2010 for irritation/sensitization, ISO 10993-5:2009 for cytotoxicity), flammability (16 CFR Part 1610 Class 1), and fluid barrier performance (ANSI/AAMI PB70:2012 Level 3, AATCC 127:2014, AATCC 42:2013).

Technological Characteristics

Extruded plastic film; open-back design with thumb loops and back perforations; non-sterile; single-use. Meets ANSI/AAMI PB70:2012 Level 3 barrier requirements. Not made with natural rubber latex.

Indications for Use

Indicated for healthcare patients and personnel to provide barrier protection against microorganisms, body fluids, and particulate material. Not for use in the operating room.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Poly-Med Disposable Personal Protective Gown Apron (K925077)

Related Devices

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K230384 — PolyWear® Personal Protective Level 3 Gown · PolyConversions, Inc. · Aug 11, 2023
K233526 — Medline Open-back Level 3 Protective Gown · Medline Industries, LP · Mar 5, 2024
K182830 — Cardinal HealthTM Poly-Coated Open-Back Protective Gown · Cardinal Health200, LLC · Apr 26, 2019
K203821 — Donagamex Blue Performance Protective Gown · Dong Nai Garment Corporation (Donagamex) · Dec 17, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ #### 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) 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. 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." {4}------------------------------------------------ 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) 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. 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." {5}------------------------------------------------ # 510(k)Summary # K160337 | Regulatory Affairs Contact: | Ms. Mary Mejaes BAM Corporation Ltd. Unit P, 12/F, Kings Wing Plaza 1 No. 3 On Kwan Street Shek 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 Gowns ValueCare® 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 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: 1. 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. 2. Backless to provide comfort 3. Thumb loops at the wrist which help to hold gown sleeves down 4. Back has perforations so the gowns can be removed without taking over the head in case they are contaminated | | Predicate Device: | Poly-Med Disposable Personal Protective Gown Apron, 510(k) K925077 | | | 510(k)Summary Page 1 out of 4 | {6}------------------------------------------------ ## 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 Back Protective Gowns 510K No: K160337 | Subject Device: SafeCare® Open Back Protective Gowns 510K No: K160337 | Predicate Device: PolyMed Disposable Personal Protective Gown Apron 510K No: K925077 | |-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Design | Design includes open back, thumb loops, back perforation for easy removal and waist tie | Design includes open back, thumb loops, back perforation for easy removal and waist tie | Design includes open back, thumb loops, back perforation for easy removal and waist tie | | Material | Made from extruded plastic film. | Made from extruded plastic film. | Made from extruded plastic film. | | Material Color | Blue | Blue or Yellow | Blue, Red, Pink, White, Yellow | | Indications for Use | These gowns are intended to protect health care patients and health care personnel from the transfer of micro- organisms, 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. | These gowns are intended to protect health care patients and health care personnel from the transfer of micro- organisms, 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. | Designed for use in healthcare to provide liquid and aerosol resistance. | | Labeling Claims | These gowns are intended to protect health care patients and health care personnel from the transfer of micro- organisms, 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. * Non-Sterile | These gowns are intended to protect health care patients and health care personnel from the transfer of micro- organisms, 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. * Non-Sterile | In compliance with OSHA Bloodborne Pathogen Standard, 29, CFR Part 1910.1030. Provides liquid and aerosol blood resistance. | | | * Not Made with Natural Rubber Latex * Meets ANSI/AAMI PB70: 2012 Level 3 * Open Back Non- protective * Single Use, Disposable | * Not Made with Natural Rubber Latex * Meets ANSI/AAMI PB70: 2012 Level 3 * Open Back Non- protective * Single Use, Disposable | Not provided | | Biocompatibility - Sensitization and Irritation | Under the condition of the studies: ISO 10993-10:2010, the device is non-irritating and non- sensitizing | Under the condition of the studies: ISO 10993-10:2010, the device is non-irritating and non- sensitizing | Not provided | | Biocompatibility- Cytotoxicity | Under the condition of the studies: ISO10993-5:2009, The test device extract did not show potential toxicity to L-929 cells | Under the condition of the studies: ISO 10993-5:2009, The test device extract did not show potential toxicity to L-929 cells | Not provided | | Barrier Testing | ANSI/AAMI PB70: 2012 Level 3: AATCC 127:2014 Hydrostatic Pressure Test AATCC 42:2013 Impact Penetration Test | ANSI/AAMI PB70: 2012 Level 3: AATCC 127:2014 Hydrostatic Pressure Test AATCC 42:2013 Impact Penetration Test | Not provided | | Flammability | Meets Class 1 "normal flammability " in accordance to 16 CFR Part 1610 | Meets Class 1 "normal flammability " in accordance to 16 CFR Part 1610 | Not provided | | Sterility | Provided non-sterile | Provided Non-sterile | Provided Non-sterile | # Comparison of Subject and Predicate Devices: {7}------------------------------------------------ # 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. {8}------------------------------------------------ - 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 Skin Irritation | Under the conditions of the studies: ISO 10993- 10:2010, the subject device is non-irritating. | | Dermal Sensitization Test | ISO 10993-10:2010 Skin Sensitization | Under the conditions of the studies: ISO 10993- 10:2010, the subject device is non-sensitizing. | | Cytotoxicity Test | ISO 10993-5:2009 In Vitro Cytotoxicity | Under the conditions of the studies: ISO 10993- 5:2009, the SafeCare® Open Back Protective Gowns and ValueCare® Open Back Protective Gowns extract did not show potential toxicity to L-929 cells. | | Flammability Test | 16 CFR Part 1610 | Subject Device meets Class 1 requirements per NFPA 16 CFR Part 1610 | | Fluid Penetration Test | ANSI/AAMI PB70:2012 AATCC 127:2014 Hydrostatic Pressure Test and AATCC 42:2013 Impact Penetration test | SafeCare® Open Back Protective Gowns and ValueCare® Open Back Protective Gowns have been successfully tested and meet the Level 3 requirements of the ANSI/AAMI PB70:2012 Liquid 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.