(128 days)
Not Found
No
The device is a physical isolation gown and the summary describes its material, construction, and performance testing against physical barrier standards. There is no mention of any software, data processing, or analytical capabilities that would involve AI/ML.
No
The device is an isolation gown intended to protect against transfer of microorganisms and body fluids, providing barrier protection. It is not designed to treat or alleviate a disease or condition.
No
Explanation: The device described is an isolation gown, which is a protective apparel used to prevent the transfer of microorganisms and body fluids. It does not perform any diagnostic function.
No
The device description clearly states it is a physical garment made of SMS nonwoven material, intended to provide a barrier. It undergoes physical and biological testing, not software validation.
Based on the provided information, 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 physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the material, construction, and barrier performance of the gown. It does not mention any components or functions related to analyzing samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Regulatory Classification: The device is identified under FDA product code FYC, which is for "Gown, Surgical Isolation." This product code is associated with personal protective equipment, not IVDs.
- Performance Studies: The performance studies focus on the physical properties and barrier performance of the gown (strength, tearing, barrier level, flammability, biocompatibility). They do not involve any diagnostic performance metrics.
In summary, the Isolation Gown is a medical device intended for physical protection, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
The Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FYC
Device Description
The Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Isolation Gown is offered in two colors (yellow and blue) and each color is offered in five sizes (S, M, L, XL and XXL) for a total of ten models. Each model is constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. The Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations.
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 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)
Non-clinical tests were conducted to verify that the proposed device met all design specification. The test results demonstrated that the proposed device complies with the following standards and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
- Water Resistance: Hydrostatic Pressure Test (AATCC 127-2018e) - Passed (Result of Yellow Isolation Gown XXL: Passed, Result of Blue Isolation Gown XXL: Passed)
- Water Resistance: Impact Penetration Test (AATCC 42-2017) - Passed (Result of Yellow Isolation Gown XXL: Passed, Result of Blue Isolation Gown XXL: Passed)
- Breaking Strength and Elongation (ASTM D 5034-2009 (2017)) - Passed (Result of Yellow Isolation Gown XXL: Passed, Result of Blue Isolation Gown XXL: Passed)
- Tearing Strength (ASTM D 5587-2015) - Passed (Result of Yellow Isolation Gown XXL: Passed, Result of Blue Isolation Gown XXL: Passed)
- Seam Strength (ASTM D1683/D1683M-2017 (2018)) - Passed (Result of Yellow Isolation Gown XXL: Passed, Result of Blue Isolation Gown XXL: Passed)
- Lint and other particles generation in the dry state (ISO 9073-10:2003) - Reported Data (Yellow: Average 187 total linting, Average 2.3 coefficient of linting; Blue: Average 584 total linting, Average 2.8 coefficient of linting)
- Thermal and Evaporative Resistance (ASTM F 1868-2017) - Reported Data (Yellow: 0.00217 m2·kPa/W; Blue: 0.00198 m2·kPa/W)
- Flammability Test (16 CFR Part 1610) - Passed (Class I for both Yellow and Blue)
- Mass Per Unit Area (ISO 9073-1:1989) - Reported Data (Yellow: 39.56; Blue: 40.62)
Biocompatibility Evaluation:
- Cytotoxicity (ISO 10993-5) - Non-cytotoxic, Passed
- Sensitization (ISO 10993-10) - Non-sensitizing, Passed
- Irritation (ISO 10993-10) - Negligibly irritating, Passed
The subject isolation gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, material composition, and configuration. The tearing strength (both warp direction and filing direction) is slightly different from that of the predicate device. The tearing strength of the proposed device has been tested according to ASTM D5587-15 and met the requirement of the standard.
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.
K160339 Cardinal Health™ Isolation Gown
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 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.
August 12, 2022
Allmed Medical (Hubei) Protective Products Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China
Re: K221027
Trade/Device Name: Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYC Dated: April 6, 2022 Received: April 6, 2022
Dear Ivy Wang:
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.
1
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 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 mediation-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.
Bifeng Oian, M.D., 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221027
Device Name Isolation Gown (S, M, L, XL, XXL (Yellow, Blue))
Indications for Use (Describe)
The Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical nonsterile.
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)
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X 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."
3
510(K) Summary (K221027)
(As requirement by 21 CFR 807.92)
Date prepared: 25th, March, 2022
A. Applicant:
Name: Allmed Medical (Hubei) Protective Products Co., Ltd Address: No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China Contact Person: Vince Tian Title: General Manager of Quality Tel: 86 717 4215906 Fax: 86 717 4215989 Email: vince@allmed.cn
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device:
Trade Name:Isolation Gown Model: S. M. L. XL. XXL (Yellow, Blue)
Regulatory Information Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
C. Predicate device: K160339 Cardinal Health™ Isolation Gown Cardinal Health 200, LLC
D. Indications for use of the device:
4
The Isolation Gowns are intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, The Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Isolation Gowns are a single use, disposable medical device provided non-sterile.
E. Device Description:
The Isolation Gown is a surgical isolation gown with moderate barrier protection identified by Regulation 21 CFR 878.4040 under FDA product code, FYC. The Isolation Gown is offered in two colors (yellow and blue) and each color is offered in five sizes (S, M, L, XL and XXL) for a total of ten models. Each model is constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. The Isolation Gown is a single use, disposable medical device that will be provided in a variety of non-sterile packaging configurations.
F. Non-clinical Test Conclusion
The Isolation Gowns were tested in accordance with the tests recommended in ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
| Test Item | Test Standard | Acceptance
Criteria for
Level 3 Barrier | Result of Yellow
Isolation Gown
XXL | Result of Blue
Isolation Gown
XXL |
|------------------------------------------------------|----------------------------|-----------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------------|
| Water
Resistance:
Hydrostatic
Pressure Test | AATCC 127-2018e | ≥50 cmH2O per
standard
ANSI/AAMI
PB70:2012 for
level 3 | Passed | Passed |
| Water
Resistance:
Impact
Penetration Test | AATCC 42-2017 | ≤1.0g AQL: 4%
Level 3 per
standard
ANSI/AAMI
PB70:2012 for
level 3 | Passed | Passed |
| Breaking
Strength and
Elongation | ASTM D 5034-2009
(2017) | ≥30N(7lbf) | Passed | Passed |
| Tearing Strength | ASTM D 5587-2015 | ≥10N (2.3 lbf) | Passed | Passed |
Based upon the document the following testing has been performed.
5
| (2019) | ||||
|---|---|---|---|---|
| Seam Strength | ASTM | |||
| D1683/D1683M-2017 | ||||
| (2018) | ≥30N (7lbf) | Passed | Passed | |
| Lint and other | ||||
| particles | ||||
| generation in the | ||||
| dry state | ISO 9073-10:2003 | Reported Data | Lint and other | |
| particles | ||||
| generation in the dry | ||||
| state[Material] | ||||
| Total linting: | ||||
| A: face 222 | ||||
| B: face 152 | ||||
| Average 187 | ||||
| Coefficient of linting: | ||||
| A: face 2.3 | ||||
| B: face 2.2 | ||||
| Average 2.3 | Lint and other | |||
| particles | ||||
| generation in the dry | ||||
| state[Material] | ||||
| Total linting: | ||||
| A: face 527 | ||||
| B: face 641 | ||||
| Average 584 | ||||
| Coefficient of linting: | ||||
| A: face 2.7 | ||||
| B: face 2.8 | ||||
| Average 2.8 | ||||
| Thermal and | ||||
| Evaporative | ||||
| Resistance | ASTM F 1868-2017 | Reported Data | Evaporative | |
| resistance(m2·kPa/W) | ||||
| [Material]: 0.00217 | Evaporative | |||
| resistance(m2·kPa/W) | ||||
| [Material]: 0.00198 | ||||
| Flammability | ||||
| Test | 16 CFR Part 1610 | Class I | Passed | Passed |
| Mass Per Unit | ||||
| Area | ISO 9073-1:1989 | Reported Data | 39.56 | 40.62 |
Biocompatibility Testing
The biocompatibility evaluation for the Isolation Gown was conducted in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The Isolation Gown is classified as a surface contacting device. Specific biocompatibility tests were selected under the guidance of ISO 10993-1:2018 Annex A.
| Biocompatibility Evaluation | ||||
|---|---|---|---|---|
| Biological Effect | Standard | Result | ||
| 1 | Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Passed |
| 2 | Sensitization | ISO 10993-10 | Non-sensitizing | Passed |
| 3 | Irritation | ISO 10993-10 | Negligibly irritating | Passed |
G. Summary of Technological Characteristics
Table 1 General Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| -------- | ----------------- | ------------------ | -------- |
6
| 510K # | - | K160339 | - |
|---|---|---|---|
| Manufacturer | Allmed Medical ( Hubei ) Protective | ||
| Products Co., Ltd | Cardinal Health 200, LLC | - | |
| Product Name | Isolation Gown | Cardinal Health™ Isolation Gown | Similar |
| Level | Level 3 | Level 3 | Same |
| Product Code | FYC | FYC | Same |
| Regulation Number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Indications for use | The Isolation Gowns are intended to | ||
| protect health care patients and health | |||
| care personnel from the transfer of | |||
| microorganisms, body fluids and | |||
| particulate material. Not intended for | |||
| use in the operating room. In addition, | |||
| The Isolation Gowns meet the | |||
| requirements of an AAMI Level 3 | |||
| barrier protection for an isolation gown | |||
| per ANSI/AAMI PB70:2012 Liquid | |||
| Barrier Performance and Classification | |||
| of Protective Apparel and Drapes | |||
| Intended for Use in Health Care | |||
| Facilities (ANSI/AAMI PB70). The | |||
| Isolation Gowns are a single use, | |||
| disposable medical device provided | |||
| non-sterile. | Cardinal HealthTM Isolation Gown is | ||
| intended to protect health care patients | |||
| and health care personnel from the | |||
| transfer of microorganisms, body fluids | |||
| and particulate material. Not intended | |||
| for use in the operating room. In | |||
| addition, The Cardinal HealthTM | |||
| Isolation Gown meets the requirements | |||
| of an AAMI Level 3 barrier protection | |||
| for an isolation gown per ANSI/AAMI | |||
| PB70:2012 Liquid Barrier Performance | |||
| and Classification of Protective Apparel | |||
| and Drapes Intended for Use in Health | |||
| Care Facilities (ANSI/AAMI | |||
| PB70).The Cardinal HealthTM | |||
| Isolation Gown is a single use, | |||
| disposable medical device provided | |||
| non-sterile. | Same | ||
| Design Feature | Tape Neck Closure | ||
| Belt Tie | |||
| Elastic Cuffs | Medical Tape Neck Closure | ||
| White Belt Tie | |||
| Elastic Cuffs | Similar | ||
| Material | |||
| Composition | Body, Sleeves and Belt:Polypropylene | ||
| SMS non-woven | |||
| Cuff: Polyester | Polyolefin (Polypropylene) SMS | ||
| nonwoven | Similar | ||
| Color | Blue and Yellow | Blue and Yellow | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
Table 2 Performance Comparison of Proposed and Predicate Devices
| Element of
Comparison | Proposed Device
(Yellow) | Proposed Device
(Blue) | Predicate Device
(K160339)
(Yellow) | Predicate Device
(K160339)
(Blue) | Comparison | | |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|-----|
| Basis weight | 39.56g/m²
(1.17 oz/yd²) | 40.62g/m²
(1.20 oz/yd²) | Mean = 1.21
Ind Min = 1.19 | Mean = 1.18
Ind Min = 1.15 | Similar | | |
| | | | Ind Max = 1.23
Unit: oz/yd² | Ind Max = 1.20
Unit: oz/yd² | | | |
| Grab tensile MD
ASTM D5034 | Average
value:88.53N
(20 lbs) | Average
value:139.39N
(31.32 lbs) | Mean = 24.38
Ind Min = 21.94
Ind Max = 26.28
Unit: lb | Mean = 22.23
Ind Min = 20.42
Ind Max = 24.03
Unit: lb | Similar | | |
| Grab tensile CD
ASTM D5034 | Average
value:58.05N
(13.05 lbs) | Average
value:77.01N
(17.31 lbs) | Mean = 14.54
Ind Min = 12.70
Ind Max = 16.45
Unit: lb | Mean = 14.18
Ind Min = 12.40
Ind Max = 15.76
Unit: lb | Similar | | |
| Trap Tear MD
ASTM D5587-15 | Average
value:24.52N
(5.51 lbs) | Average
value:34.42N
(7.74 lbs) | Mean = 4.74
Ind Min = 3.67
Ind Max = 5.47
Unit: lb | Mean = 4.40
Ind Min = 3.26
Ind Max = 5.54
Unit: lb | Different | | |
| Trap Tear CD
ASTM D5587-15 | Average
value:15.13N
(3.4 lbs) | Average
value:17.54N
(3.94 lbs) | Mean = 9.24
Ind Min = 7.54
Ind Max = 12.98
Unit: lb | Mean = 7.99
Ind Min = 6.64
Ind Max = 11.11
Unit: lb | Different | | |
| Flammability
Part 1610 | Class I | Class I | Class I | Class I | Same | | |
| Hydrostatic Head
(cm)
AATCC 127 | Body/Sleeve
Ind Min-51.02
Ind Max=82.86 | Body/Sleeve
Ind Min-52.24
Ind Max=101.22 | Body/Sleeve:
Mean = 69
Ind Min = 56
Ind Max = 84 | Body/Sleeve:
Mean = 72
Ind Min = 53
Ind Max = 80 | Similar | | |
| Water Impact (g)
AATCC 42 | Body/Sleeve:
Ind Min = 0.0
Ind Max = 0.3 | Body/Sleeve:
Ind Min = 0.0
Ind Max = 0.3 | Body/Sleeve:
Mean = 0.08
Ind Min = 0.05
Ind Max = 0.13 | Body/Sleeve:
Mean = 0.08
Ind Min = 0.04
Ind Max = 0.13 | Similar | | |
| Liquid Barrier
Performance
Classification
Properties | Device was tested in accordance with
ANSI/AAMI PB70:2012 and meets
Level 3 requirements for an isolation
gown. The critical zone areas tested
were the the body and sleeve (same
fabric), the sleeve seam, the shoulder
seam, and binding material. | | Device was tested in accordance with
ANSI/AAMI PB70:2012 and meets
Level 3 requirements for an isolation
gown. The critical zone areas tested
were the body and sleeve (same
fabric), the sleeve seam, front belt or
tie attachment, and the front seam arm
attachment using multiple lots. | | Similar | | |
| Biocompatibility | The test was done against
ISO10993-5 and ISO10993-10. The
result indicates the gown is
non-cytotoxic, and non-sensitizing and
negligibly irritating | | Under the conditions of each study, the
Cardinal HealthTM Isolation gown is
non-cytotoxic, non-irritating, and
non-sensitizing per ISO 10993-1. | | Same | | |
| Sterilization
Modality | None (Non-sterile) | | | None (Non-sterile) | Same | | |
| Seam Strength | Seam Strength: | Seam Strength: | Performance values not available in
predicate 510(k) submission | N/A | | | |
| | 58.18N | 65.27N | | | | | |
| | Seam Strength
Ultimate | Seam Strength
Ultimate | | | | | |
| | Elongation(%):51.
04 | Elongation(%):32.
63% | | | | | |
| | Lint and other
particles
generation in the
dry state | Lint and other
particles
generation in the
dry state[Material]
Total linting:
A: face 222
B: face 152
Average 187
Coefficient of
linting:
A: face 2.3
B: face 2.2
Average 2.3 | | | Lint and other
particles
generation in the
dry state[Material]
Total linting:
A: face 527
B: face 641
Average 584
Coefficient of
linting:
A: face 2.7
B: face 2.8
Average 2.8 | Performance values not available in
predicate 510(k) submission | N/A |
| | Thermal and
Evaporative
Resistance | Evaporative
resistance(m2·kPa/
W)
[Material]:
0.00217 | | | Evaporative
resistance(m2·kPa/
W)
[Material]:
0.00198 | Performance values not available in
predicate 510(k) submission | N/A |
7
8
Analvsis:
The subject isolation gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, material composition, and configuration. The tearing strength (both warp direction and filing direction) is slightly different from that of the predicate device. The tearing strength of the proposed device has been tested according to ASTM D5587-15 and met the requirement of the standard.
Under the conditions of each study, the subject isolation gown is non-cytotoxic, non-sensitizing and neeligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for an AAMI Level 3 isolation gown.
H. Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specification. The test results demonstrated that the proposed device complies with the following standards and ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
- ISO 10993-05:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity A
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin
9
Sensitization
-
ASTM D5034-09 (2017), Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
-
ASTM D5587-15 (2019), Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
- AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and > Drapes Intended For Use In Health Care Facilities
-
ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
-
ISO 9073-10-2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state
- A ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- A 16 CFR 1610, Standard for the Flammability of Clothing Textiles
I. Clinical Test Conclusion
No clinical study is included in this submission.
J. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the subject Isolation Gown is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160339.