(515 days)
Not Found
No
The device is a protective gown made of plastic film, with no mention of software, data processing, or any AI/ML related terms or functionalities.
No.
This device is described as a protective gown intended to prevent the transfer of microorganisms and body fluids, not to treat or diagnose a disease or condition.
No
Explanation: The device described is a protective gown, which is a barrier device intended to protect against the transfer of microorganisms and fluids. It does not perform any diagnostic function.
No
The device description clearly states it is made from "extruded plastic film" and describes physical characteristics like "thumb loops" and "perforations," indicating it is a physical product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gowns are for protecting healthcare patients and personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier protection function, not a diagnostic function.
- Device Description: The description focuses on the physical properties of the gowns as a barrier (extruded plastic film, barrier testing, design points like thumb loops and perforations). There is no mention of any components or functions related to testing samples from the human body.
- Performance Studies: The performance studies listed are related to the safety and barrier properties of the material (dermal irritation, sensitization, cytotoxicity, flammability, fluid penetration). These are relevant to personal protective equipment, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the provided information describes a piece of personal protective equipment (PPE) designed to prevent the transfer of substances, not a device used to diagnose conditions by testing samples outside of the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QPC, FYC
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
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
health care patients and health care personnel
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)
Comparison of Subject and Predicate Devices:
Aspect: Biocompatibility -Sensitization and Irritation
Subject Device: Under the condition of the studies: ISO 10993-10:2010, the device is non-irritating and non- sensitizing
Aspect: Biocompatibility- Cytotoxicity
Subject Device: Under the condition of the studies: ISO10993-5:2009, The test device extract did not show potential toxicity to L-929 cells
Aspect: Barrier Testing
Subject Device: ANSI/AAMI PB70: 2012 Level 3: AATCC 127:2014 Hydrostatic Pressure Test AATCC 42:2013 Impact Penetration Test
Aspect: Flammability
Subject Device: Meets Class 1 "normal flammability " in accordance to 16 CFR Part 1610
Summary of Testing:
Test Performed: Dermal Irritation Test
Test Standard: ISO 10993-10:2010 Skin Irritation
Results: Under the conditions of the studies: ISO 10993- 10:2010, the subject device is non-irritating.
Test Performed: Dermal Sensitization Test
Test Standard: ISO 10993-10:2010 Skin Sensitization
Results: Under the conditions of the studies: ISO 10993- 10:2010, the subject device is non-sensitizing.
Test Performed: Cytotoxicity Test
Test Standard: ISO 10993-5:2009 In Vitro Cytotoxicity
Results: 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.
Test Performed: Flammability Test
Test Standard: 16 CFR Part 1610
Results: Subject Device meets Class 1 requirements per NFPA 16 CFR Part 1610
Test Performed: Fluid Penetration Test
Test Standard: ANSI/AAMI PB70:2012 AATCC 127:2014 Hydrostatic Pressure Test and AATCC 42:2013 Impact Penetration test
Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Poly-Med Disposable Personal Protective Gown Apron, 510(k) K925077
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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:
- 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 |
| 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.