(353 days)
Not Found
No
The device description and performance studies focus on the physical barrier properties and biocompatibility of a protective gown, with no mention of AI or ML technology.
No
Explanation: The device is a protective gown intended to protect against microorganisms, body fluids, and particulate matter, not to treat or prevent a disease or condition. It is classified as surgical apparel under 21 CFR 878.4040.
No
The device is a protective gown, a type of surgical apparel, designed to protect against microorganisms and body fluids. It does not perform any diagnostic function.
No
The device description clearly states it is a physical protective gown made from non-woven material, polyethylene, and polypropylene, and describes physical testing (barrier protection, biocompatibility). There is no mention of software.
Based on the provided text, the Donagamex protective gown is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the gown is "intended to be worn by healthcare persomel to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter." This describes a physical barrier for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the physical characteristics of the gown (material, construction, barrier level) and its classification as a Class II medical device under a regulation for general and plastic surgery devices (21 CFR 878.4040). This regulation is for surgical apparel, not IVD devices.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Being used in a laboratory setting for testing
The Donagamex protective gown is a medical device intended for personal protection, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare personnel to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).
The Donagamex protective gowns are sold non-sterile, single use. They are not intended for use in the operating room.
Product codes (comma separated list FDA assigned to the subject device)
OPC, QPC
Device Description
The Donagamex Blue Performance Protective Gown is a Class II medical device under the FDA product code QPC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Donagamex Blue Performance Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993. The Donagamex Blue Performance Protective Gowns are non-woven, blue gowns, available in various sizes and have no areas of reinforcement. They are made from a layer of polyethylene laminated over spun-bonded polypropylene and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a protective gown. The Donagamex Blue Performance Protective Gown is a single use, disposable medical device that will be sold non-sterile.
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
healthcare 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)
The device was tested in accordance with AAMI PB 70:2012 and meets AAMI Level 3 barrier protection requirements for a protective gown. Testing was performed using 3 nonconsecutive lots and 32 samples per lot in each critical zone area. The critical zone areas tested were the chest, back and sleeve seam.
Performance test results for the subject device include:
- AATCC 42 Water Resistance: Impact Penetration (g): Meets AAMI PB70 Barrier Classification for Level 3
- AATCC 127 Water Resistance: Hydrostatic Pressure (cm): Meets AAMI PB70 Barrier Classification for Level 3
- ASTM - D3776 Standard Test Methods for Mass Per Unit Area (Weight) of Fabric: Pass
- ASTM - D5034 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test): Pass
- ASTM - D5587 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure: Pass
- ASTM - D751 Standard Test Methods for Coated Fabrics (Seam Strength): Pass
- Flammability Test Method Standard for Flammability of Clothing Textiles (16 CFR Part 1610): Meets Class I Flammability per CPSC, Part 1610
- Textiles ISO 9073-10 Test Method for Nonwovens Part 10: Lint & other Particles Generation in the Dry State: Pass
- ISO 10993 Part-1 Biological Evaluation of Medical Devices. Biocompatibility tests included cytotoxicity, sensitization and irritation: Non-cytotoxic, non-sensitizing, non-irritating
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.
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
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 10, 2022
Dong Nai Garment Corporation (Donagamex) % Bari Steinberg Official Correspondent for Dong Nai Garment Corporation (Donagamex) mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K203821
Trade/Device Name: Donagamex Blue Performance Protective Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: OPC
Dear Bari Steinberg:
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 December 17, 2021. Specifically, FDA is updating this SE Letter to inlude the finalized trade name of the device as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Clarance Murray, OHT4: Office of Surgical and Infection Control Devices, 301-796-0870, Clarence.Murray@fda.hhs.gov.
Sincerely,
Liqun Zhao -S
For Clarence W. Murray, III, Ph.D. 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2021
Dong Nai Garment Corporation (Donagamex) Bari Steinberg Official Correspondent for Dong Nai Garment Corporation (Donagamex) mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K203821
Trade/Device Name: Donagamex Blue Performance Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OPC Dated: August 29, 2021 Received: September 7, 2021
Dear Bari Steinberg:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
2
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ligun Zhao -S
For Clarence W. Murray, III, Ph.D. 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
Enclosure
3
Indications for Use
510(k) Number (if known) K203821
Device Name
Donagamex Blue Performance Protective Gown
Indications for Use (Describe)
Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare persomel to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter.
The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/A AMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).
The Donagamex protective gowns are sold non-sterile, single use. 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) |
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4
510(K) SUMMARY
The assigned 510(k) number is: K203821
Date Summary Prepared: December 17, 2021
1. Submitter's Identification:
Dong Nai Garment Corporation
Road 2, Bien Hoa Industrial Zone 1 An Binh Ward, Bien Hoa City Dong Nai Province, Vietnam Tel.: +84 0253 836147 Fax: +84 0253 836151
Official Correspondent: Bari Steinberg, mdi Consultants Inc. E-mail: bari@mdiconsultants.com
2. Device Name: Donagamex Blue Performance Protective Gown
3. Regulatory Information:
Regulation Number: 21 CFR 878.4040 Device Class: Class II Regulation Name: Surgical Apparel Product Code: QPC Common Name: Gown, Non-Sterile, Non-Isolation
4. Predicate Device Information:
510K Number: K160337 Device Name: ValueCare Open Back Protective Gown
5. Intended Use:
Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare personnel to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).
The Donagamex protective gowns are sold non-sterile, single use. They are not intended for use in the operating room.
5
6. Device Description:
The Donagamex Blue Performance Protective Gown is a Class II medical device under the FDA product code QPC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Donagamex Blue Performance Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993. The Donagamex Blue Performance Protective Gowns are non-woven, blue gowns, available in various sizes and have no areas of reinforcement. They are made from a layer of polyethylene laminated over spun-bonded polypropylene and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a protective gown. The Donagamex Blue Performance Protective Gown is a single use, disposable medical device that will be sold non-sterile.
7. Device and Predicate Device Technical Characteristics:
| COMPARISON
CRITERIA | SUBJECT DEVICE
(K203821) | PREDICATE DEVICE
(K160337) | COMPARISON
RESULT |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Device Name | Donagamex Blue
Performance Protective
Gown
(AAMI Barrier Level 3) | ValueCare Open Back
Protective Gowns
(AAMI Barrier Level 3) | N/A |
| Manufacturer | Dong Nai Garment
Corporation (Donagamex) | ValueCare | N/A |
| Classification | Surgical Apparel
21 CFR Part 878.4040
Product Code: QPC
Class II | Surgical Apparel
21 CFR Part 878.4040
Product Code: QPC
Class II | Same |
| Indications for Use | Donagamex Blue
Performance Protective
Gowns are non-sterile,
single use surgical apparel
intended to be worn by
healthcare professionals to
help protect both the
patient and the health care
personnel from the
transfer of microorganisms,
body fluids, and particulate
matter.
The Donagamex Protective
gown meets the
requirements of AAMI
Level 3 barrier protection
for a protective gown per | 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. | Similar |
| | | | |
| ANSI/AAMI PB70: 2012
Liquid Barrier Performance
and Classification of
protective apparel and
drapes intended for use in
healthcare facilities (AAMI
PB70).
The Donagamex protective
gowns are sold non-sterile,
single use. They are not
intended for use in the
operating room. | | | |
| Sterile or Non-Sterile | Non-Sterile | Non-sterile | Same |
| Reusable or
Disposable (Single
Use) | Single use | Single use | Same |
| Design | Elastic at the cuff for
keeping the sleeves in
place on the wearer,
belt tie | Design includes open back,
thumb loops, back
perforation for easy removal
and waist tie | Similar |
| Material
Composition | Nonwoven polypropylene
spunbond fabric
with polyethylene laminate
film (SF) | Made from extruded plastic
film | Similar |
| Size | Medium to XX-Large | Not reported in 510k
Summary | N/A |
| Color | Blue | Blue | Same |
| Sterilization
Method (if
applicable) | None, non-sterile gowns | None, non-sterile gowns | Similar |
| Packaging | Bulk for non-sterile gowns | Not reported in 510k
Summary | N/A |
| Natural rubber
Latex | Not made with natural
rubber latex | Not made with Natural
Rubber Latex | Same |
| PERFORMANCE TEST RESULTS : | | | |
| AATCC 42 Water
Resistance: Impact
Penetration (g) | Meets AAMI PB70 Barrier
Classification for Level 3 | Meets AAMI PB70 Barrier
Classification for Level 3 in
critical zones | Same |
| AATCC 127 Water
Resistance:
Hydrostatic
Pressure (cm) | Meets AAMI PB70 Barrier
Classification for Level 3 | Meets AAMI PB70 Barrier
Classification for Level 3 in
critical zones | Same |
| Liquid Barrier
Performance
Classification | Device was tested in
accordance with AAMI PB
70:2012 and meets AAMI
Level 3 barrier protection
requirements for a
protective gown. Testing
was performed using 3
nonconsecutive lots and 32
samples per lot in each
critical zone area. The
critical zone areas tested
were the chest, back and
sleeve seam. | Device meets the barrier
protection requirements of
AAMI Level 3 per
ANSI/AAMI PB70:2012, but
has an open back which is
non-protective. | Similar |
| ASTM - D3776
Standard Test
Methods for Mass
Per Unit Area
(Weight) of Fabric | Pass | Not reported in 510k
Summary | N/A |
| ASTM - D5034
Standard Test
Method for
Breaking Strength
and Elongation of
Textile Fabrics
(Grab Test) | Pass | Not reported in 510k
Summary | N/A |
| ASTM - D5587
Standard Test
Method for
Tearing Strength of
Fabrics by
Trapezoid
Procedure | Pass | Not reported in 510k
Summary | N/A |
| ASTM - D751
Standard Test
Methods for
Coated Fabrics
(Seam Strength) | Pass | Not reported in 510k
Summary | N/A |
| Flammability Test
Method Standard
for Flammability of
Clothing Textiles
(16 CFR Part 1610) | Meets Class I Flammability
per CPSC, Part 1610 | Meets Class I Flammability
per CPSC, Part 1610 | Same |
| Textiles ISO 9073-
10
Test Method for
Nonwovens Part
10: Lint & other | Pass | Not reported in 510k
Summary | N/A |
| Particles
Generation in the
Dry State | | | |
| ISO 10993 Part-1
Biological
Evaluation of
Medical Devices.
Biocompatibility
tests included
cytotoxicity,
sensitization and
irritation. | Non-cytotoxic, non-
sensitizing, non-irritating | Non-cytotoxic, non-
sensitizing, non-irritating | Same |
Table 1: Side by Side Comparison
6
7
8
Both gowns are disposable, single use, non-reinforced gowns intended to help protect from the transfer of body fluids and particulate matter in settings other than the operating room. They are similar in color, design and are both offered as non-sterile.
The primary difference is that the ValueCare Open Back Protective Gown provides liquid barrier protection in front of gown only (critical zones), while the Donagamex Blue Performance Protective Gowns provide AAMI Level 3 in front and back of gown.
The above differences in design and AAMI liquid protection level raise no new issues of safety and effectiveness since both gowns are designed, tested, and labeled in compliance with the applicable AAMI PB70: 2012 liquid barrier requirements.
8. Summary of Clinical Testing:
Clinical performance for non-sterile, disposable protective gowns is not applicable for this product. Numerous predicated devices (gowns) exist and have been used extensively for a number of years that are made from the same or similar materials.
9. Summary of Non-Clinical Performance Testing:
The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design test methods including physical, mechanical, liquid barrier and biocompatibility testing. The Donagamex Blue Performance Protective Gown was found to be acceptable for its intended use in each of these applicable industry recognized standards:
AATCC 42:2017 Standard Test Method for Water Resistance: Impact Penetration
AATCC 127:2018 Standard Test Method for Water Resistance: Hydrostatic Pressure
ASTM - D5034:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM - D5587:2019 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
9
ASTM - D751:2019 Standard Test Methods for Coated Fabrics
ASTM - D3776:2020 Standard Test Methods for Mass Per Unit Area (Weight) of Fabric
16 CFR Part 1610 - Flammability Test Method Standard for Flammability of Clothing Textiles
ISO 9073-10 Textiles - Test Method for Nonwovens Part 10: Lint & other Particles Generation in the Dry State
AMMI /ANSI / ISO 10993-5:2009 – In Vitro Cytotoxicity using Agar Overlay test (USP, ISO)
AAMI / ANSI / ISO 10993-10:2010 – In Vitro Irritation reactivity using Primary Skin Irritation Test
AAMI / ANSI / ISO 10993-10:2010 – In Vitro Sensitization using the Buehler Method Test
Table 2: Non-Clinical Tests
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 42:2017 | |||
| Standard Test Method | |||
| for Water Resistance: | |||
| Impact Penetration | Determine resistance of | ||
| gown to the | |||
| penetration of water by | |||
| impact | Level 3: ≤ 1.0 gm | Pass | |
| AATCC 127:2018 | |||
| Standard Test Method | |||
| for Water Resistance: | |||
| Hydrostatic Pressure | Determine resistance of | ||
| gown to the | |||
| penetration of water | |||
| under hydrostatic | |||
| pressure | Level 3: ≥ 50 cm | Pass | |
| ASTM - D5034:2017 | |||
| Standard Test Method | |||
| for Breaking Strength | |||
| and Elongation of | |||
| Textile Fabrics (Grab | |||
| Test) | Determine the breaking | ||
| strength of gown | More or equals to | ||
| 7 lbs | Pass | ||
| ASTM - D5587:2019 | |||
| Standard Test Method | |||
| for Tearing Strength of | |||
| Fabrics by Trapezoid | |||
| Procedure | Determine the tearing | ||
| strength of gown | More or equals to | ||
| 2.3 lbs | Pass | ||
| ASTM - D751:2019 | |||
| Standard Test Methods | |||
| for Coated Fabrics | Determine if any failure | ||
| occurs in gown seams | More or equals to | ||
| 7 lbs | Pass | ||
| ASTM - D3776:2020 | |||
| Standard Test Methods | |||
| for Mass Per Unit Area | |||
| (Weight) of Fabric | Determine the fabric | ||
| weight | N/A | N/A |
10
| Flammability Test
Method Standard for
Flammability of
Clothing Textiles (16
CFR Part 1610) | To test the clothing
textile flammability | Class I Normal
Flammability Result | Pass |
|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------|------|
| ISO 9073-10
Textiles - Test Method
for Nonwovens Part 10:
Lint & other Particles
Generation in the Dry
State | Characterize the size
and quantity of the lint
generation | N/A | N/A |
Table 3: Biocompatibility Tests
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| In vitro Cytotoxicity | |||
| ISO 10993-5:2009 | To determine if device | ||
| extract is cytotoxic | The device must be non- | ||
| cytotoxic | Under the study | ||
| conditions non- | |||
| cytotoxic | |||
| Primary Skin Irritation | |||
| ISO 10993-10:2010 | To determine if device is | ||
| a skin irritant | The device must be a | ||
| non-irritant | Under the study | ||
| conditions not an | |||
| irritant | |||
| Dermal Sensitization | |||
| ISO 10993-10:2010 | To determine if device is | ||
| a dermal sensitizer | The device must be a | ||
| non-sensitizer | Under the study | ||
| conditions not a | |||
| sensitizer |
10. Conclusions:
Based on the non-clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, K160337.