(372 days)
Not Found
No
The 510(k) summary describes a physical surgical gown and its material properties and performance against standards. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a surgical gown, intended to protect from transfer of microorganisms and fluids, not to treat or diagnose a disease or condition.
No
This device is a surgical gown, intended to protect personnel and patients from the transfer of microorganisms and fluids during surgical procedures. It does not perform any diagnostic function.
No
The device described is a physical surgical gown, not a software application. The description focuses on material properties, barrier performance, and sterilization methods, all related to a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical gown is "to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material." This describes a barrier function for protection, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description focuses on the physical characteristics of the gown (material, sizes, barrier levels) and its function as protective apparel. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Reagents or assays
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly described as a piece of protective medical apparel used in a surgical setting.
N/A
Intended Use / Indications for Use
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications.
The gowns are provided sterile and non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile.
There are two types of surgical gown: Comfort Gown and Safewear Gown. And each type of surgical gown is available in five product sizes, including M, L, XL, XXL and XXXL.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Comfort Gown include Level 1 standard surgical gown which met the requirements for Level 1 classification, and Level 2 standard surgical gown which met the requirements for Level 2 classification. It is made of the same material and is classified as Level 1 and Level 2 standard surgical gowns based on marketing reasons.
Safewear gown include Level 3 standard surgical gown, Level 3 standard plus surgical gown, Level 3 reinforced surgical gown and Level 3 reinforced plus surgical gown, which all met the requirements for AAMI Level 3. The four Level 3 surgical gowns differ in the weight of non-woven and whether there are reinforcements, which is 45g/m² and 50g/m² for Level 3 standard surgical gown, 50g/m² for Level 3 standard plus surgical gown, 35g/m² for Level 3 reinforced surgical gown with 35g/m² PE breathable film reinforcement and 45g/m2 for Level 3 reinforced plus surgical gown with 35g/m² PE breathable film reinforcement.
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
operating room 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 specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test
- AATCC 42: 2017 Water Resistance: Impact Penetration Test
- ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State
- ASTM D1683/D1683M: 2017 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- ASTM D5587:2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics
- ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
Key results from the tests:
- Flammability: Class 1
- Hydrostatic Pressure: Level 2 Surgical Gown: >20 cm H2O (PASS); Level 3 Surgical Gown: >50 cm H2O (PASS) for all types of Level 3 surgical gowns.
- Water Impact: 30 ft³/min/ft² (Results ranging from 32.68 to 40.55 ft³/min/ft²).
- Cytotoxicity: Non-cytotoxic (Viability >= 70% of blank).
- Sensitization: Non-sensitizing.
- Irritation: Non-irritating.
No clinical study is included in this submission.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 21, 2022
Xuchang Zhengde Environstar Medical Products Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China
Re: K213893
Trade/Device Name: Comfort Gown, Safewear Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: November 22, 2022 Received: November 30, 2022
Dear Diana Hong:
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
1
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,
Allan Guan -S
For Bifeng Qian, 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) K213893
Device Name Comfort Gown, Safewear Gown
Indications for Use (Describe)
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications.
The gowns are provided sterile and non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
| 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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K213893
-
- Date of Preparation: 12/20/2022
-
- Sponsor Identification
Xuchang Zhengde Environstar Medical Products Co., Ltd.
Area B, Baihua Road East, South Side of Erji river, Industry Cluster District, Yanling County, 461200 Xuchang, Henan, CHINA
Establishment Registration Number: 3009114792
Contact Person: Vincent Yu Position: Regulatory Engineer Tel: +86-18658510660 Email: yjf(@zhende.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Comfort Gown, Safewear Gown Common Name: Surgical Gown
Regulatory Information
Classification Name: Gown, Surgical Classification: II; Product Code: FYA; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;
Indications for use:
Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Comfort Gown met the requirements for Level 1 and Level 2 Standard Surgical Gown classifications, and Safewear Gown met the requirements for Level 3 Standard Surgical Gown, Level 3 Standard Plus Surgical Gown, Level 3 Reinforced Surgical Gown and Level 3 Reinforced Plus Surgical Gown classifications. The gowns are provided sterile. Non-sterile gowns are to be sold in bulk to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135
Device Description:
The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and can be provided in sterile and non-sterile.
There are two types of surgical gown: Comfort Gown and Safewear Gown. And each type of surgical gown is available in five product sizes, including M, L, XL, XXL and XXXL.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the Comfort Gown include Level 1 standard surgical gown which met the requirements for Level 1 classification, and Level 2 standard surgical gown which
5
met the requirements for Level 2 classification. It is made of the same material and is classified as Level 1 and Level 2 standard surgical gowns based on marketing reasons.
Safewear gown include Level 3 standard surgical gown, Level 3 standard plus surgical gown, Level 3 reinforced surgical gown and Level 3 reinforced plus surgical gown, which all met the requirements for AAMI Level 3. The four Level 3 surgical gowns differ in the weight of non-woven and whether there are reinforcements, which is 45g/m² and 50g/m² for Level 3 standard surgical gown, 50g/m² for Level 3 standard plus surgical gown, 35g/m² for Level 3 reinforced surgical gown with 35g/m² PE breathable film reinforcement and 45g/m2 for Level 3 reinforced plus surgical gown with 35g/m² PE breathable film reinforcement. Detailed specifications for the proposed device are shown in the table below.
| Proposed
device | Type | Size | Style | AAMI
Level |
|--------------------|---------------------------------------|---------------------|----------------|---------------|
| Comfort
Gown | Level 1 Standard Surgical Gown | M, L, XL, XXL, XXXL | Non-reinforced | 1 |
| Comfort
Gown | Level 2 Standard Surgical Gown | M, L, XL, XXL, XXXL | Non-reinforced | 2 |
| Comfort
Gown | Level 3 Standard Surgical Gown | M, L, XL, XXL, XXXL | Non-reinforced | 3 |
| Safewear
Gown | Level 3 Standard Plus Surgical Gown | M, L, XL, XXL, XXXL | Non-reinforced | 3 |
| Safewear
Gown | Level 3 Reinforced Surgical Gown | M, L, XL, XXL, XXXL | Reinforced | 3 |
| Safewear
Gown | Level 3 Reinforced Plus Surgical Gown | M, L, XL, XXL, XXXL | Reinforced | 3 |
Specification of Surgical Gown Table1
-
- Identification of Predicate Devices
-
- Predicate Device 1
510(k) Number: K192290
Product Name: SMS Standard Surgical Gown, SMS Surgical Gown with Reinforcement, BVB Surgical Gown, BVB Splicing Surgical Gown
Predicate Device 2 510(k) Number: K172987 Product Name: Surgical Gown (used AE series as predicate device)
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
A 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test;
6
- AATCC 42: 2017 Water Resistance: Impact Penetration Test; >
-
ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
-
ASTM D1683/D1683M: 2017 Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
-
ASTM D5587:2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
-
ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);
-
ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics;
-
ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
- A ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
-
ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
-
ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity:
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;
| Test
| Methodology | Test Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Flammability | The test was performed in | ||
| accordance with 16 CFR | |||
| Part 1610 Standard for the | |||
| Flammability of Clothing | |||
| Textiles to evaluate the | |||
| flammability of the test | |||
| sample. | Meets Class1 | ||
| requirements | Class 1 | ||
| Hydrostatic | |||
| pressure | The test was performed in | ||
| accordance with AATCC | |||
| 127:2017 Water | |||
| Resistance Hydrostatic | |||
| Pressure Test to determine | |||
| the hydrostatic pressure of | |||
| the test sample. | Level 2 Surgical | ||
| Gown: >20 cm H2O; | |||
| Level 3 Surgical | |||
| Gown: >50 cm H2O; | |||
| AQL 4.0 | Level 2 Standard Surgical | ||
| Gown: PASS; | |||
| Level 3 Standard Surgical | |||
| Gown: PASS; | |||
| Level 3 Standard Plus | |||
| Surgical Gown: PASS; | |||
| Level 3 Reinforced | |||
| Surgical Gown: PASS; | |||
| Level 3 Reinforced Plus | |||
| Surgical Gown: PASS | |||
| Water impact | The test was performed in | 30 ft³/min/ft² | |
| (>15 cm³/s/cm²) | Level 2 Standard Surgical | ||
| Gown: | |||
| Average 40.55 ft³/min/ft² | |||
| (20.60 cm³/s/cm²); | |||
| Level 3 Standard Surgical | |||
| Gown: | |||
| Average 33.85 ft³/min/ft² | |||
| (17.20 cm³/s/cm²); | |||
| Level 3 Standard Plus | |||
| Surgical Gown: | |||
| Average 32.68 ft³/min/ft² | |||
| (16.60 cm³/s/cm²); | |||
| Level 3 Reinforced | |||
| Surgical Gown: | |||
| Average 40.55 ft³/min/ft² | |||
| (20.60 cm³/s/cm²); | |||
| Level 3 Reinforced Plus | |||
| Surgical Gown: | |||
| Average 34.84 ft³/min/ft² | |||
| (17.70 cm³/s/cm²) | |||
| Test Method | Purpose | Acceptance Criteria | Results |
| Cytotoxicity | The test was performed in accordance | ||
| with ISO 10993-5 Third edition | |||
| 2009-06-01 Biological evaluation of | |||
| medical devices - Part 5: Tests for in | |||
| vitro cytotoxicity to evaluate the | |||
| cytotoxicity of the test sample. | The viability should | ||
| be ≥70% of the | |||
| blank. And the 50% | |||
| extract of the test | |||
| sample should have | |||
| at least the same or a | |||
| higher viability than | |||
| the 100% extract. | The viability was ≥70% | ||
| of the blank. And the | |||
| 50% extract of the test | |||
| sample had a higher | |||
| viability than the 100% | |||
| extract. |
Under the conditions of
the study, the proposed
device was
non-cytotoxic. |
| Sensitization | The test was performed in accordance
with ISO 10993-10 Third Edition
2010-08-01 Biological evaluation of
medical devices - Part 10: Tests for
irritation and skin sensitization to
evaluate the sensitization of the test
sample. | Non-sensitizing | Under the conditions of
the study, the proposed
device was
non-sensitizing. |
| Irritation | The test was performed in accordance
with ISO 10993-10 Third Edition
2010-08-01 Biological evaluation of
medical devices - Part 10: Tests for
irritation and skin sensitization to
evaluate the irritation of the test
sample. | Non-irritating | Under the conditions of
the study, the proposed
device was non-irritating. |
Summary of Performance Testing Table2
7
8
9
10
Table3 Summary of Biocompatibility Testing
8. Clinical Test Conclusion
No clinical study is included in this submission.
11
9. Summary of Technological characteristics
| Table4 General Comparison for Comfort Gown | Remark | ||
|---|---|---|---|
| Item | Proposed Device | ||
| K213893 | Predicate Device 2 | ||
| K172987 | |||
| Product Code | FYA | FYA | Same |
| Regulation | |||
| No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for | |||
| Use | Surgical gown is intended to be worn | ||
| by operating room personnel during | |||
| surgical procedure to protect both the | |||
| surgical patient and the operating | |||
| room personnel from transfer of | |||
| microorganisms, body fluids, and | |||
| particulate material. | Surgical gown is intended to be worn | ||
| by operating room personnel during | |||
| surgical procedure to protect both the | |||
| surgical patient and the operating room | |||
| personnel from transfer of | |||
| microorganisms, body fluids, and | |||
| particulate material. | Same | ||
| Per ANSI/AAMI PB70:2012 Liquid | |||
| barrier performance and classification | |||
| of protective apparel and drapes | |||
| intended for use in health care | |||
| facilities, the comfort gown met the | |||
| requirements for Level 2 | |||
| classification. | Per ANSI/AAMI PB70:2012 Liquid | ||
| barrier performance and classification | |||
| of protective apparel and drapes | |||
| intended for use in health care | |||
| facilities, the AE series surgical gowns | |||
| met the requirements for Level 2 | |||
| classification. | Same | ||
| Style | Non-reinforced | Non-reinforced/Reinforced | Different |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per | |||
| square (g) | 35g/m² | 44g/m² | Different |
| Size | M, L, XL, XXL, XXXL | XL | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic | |||
| pressure | >20 cm; | AE series: >20 cm; | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking | |||
| strength | ≥30N | >20N | Different |
| Tearing | |||
| strength | ≥10N | >30N | Different |
| Seam | ≥30N | ≥30N | Same |
| Table4 General Comparison for Comfort Gown | |
|---|---|
| -- | ---------------------------------------------------- |
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| strength | |||
|---|---|---|---|
| Linting | $Log_{10}≤4$ | $Log_{10}≤4$ | Same |
| Air | |||
| permeability | >30 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier | |||
| protection | |||
| level | Level 1/Level 2 per AAMI PB 70 | Level 2 per AAMI PB 70 | Different |
| Material | SMS nonwoven, Polyester, Polyamide; | SMMMS, Polypropylene, | |
| Polyethylene, Polyester | Different | ||
| Cytotoxicity | Under the conditions of the study, the | Under the conditions of the study, the | |
| Irritation | device is non-toxic, non-irritating, and | device is non-toxic, non-irritating, and | Same |
| Sensitization | non-sensitizing. | non-sensitizing. | |
| Sterilization | Sterile/Non-Sterile | ||
| Sterile Method: Ethylene Oxide (EO); | |||
| Sterilization Assurance Level (SAL): | |||
| 10-6 | Non-sterile | Different |
Different - Weight per square
The weight per square for the proposed surgical gowns is different from the predicate device K172987. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection requirements as required by PB70. Therefore, this difference will not raise any safety issues.
Different - Size
The size for the proposed surgical gowns is different from the predicate device K172987. The proposed surgical gowns are available in 5 product sizes, including M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Breaking Strength
The breaking strength for the proposed surgical gowns is different from the predicate device K172987, however, the breaking strength of the proposed device is large than the predicate device. It can be considered that the proposed device showed a better performance to resist breaking. Therefore, this difference will not raise any safety issues.
Different - Tearing strength
13
The tearing strength for the proposed surgical gowns is different from the predicate device K172987, the tearing strength of the proposed device is less than the predicate device. The proposed acceptance criteria not less than 10N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.
Different - Barrier protection level
The barrier protection level of proposed device is not same as the predicate device K172987, the proposed Comfort Gown is available in level 2 two protection levels. These two levels gowns are exactly same and classified as Level 1 and Level 2 standard surgical gowns based on marketing reasons. The level 2 can be covered by the predicate device K172987. Although the level 1 is not covered by the predicate device K172987, since the proposed level 2 gowns are same, therefore, this difference will not raise any safety issues. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection requirements as required by PB70.
Different - Material
The material for the proposed surgical gowns is different from the predicated device. However, the biocompatibility for proposed device was evaluated and the results showed no adverse effect. Therefore, this difference will not raise any safety issues.
Different - Sterilization
The product status of the proposed device is different from the predicate device. The proposed device can be provided in sterile and non-sterile, and the predicate device is non-sterilized. However, although the predicate device is non-sterile, it shall be further sterilized prior to use. In addition, sterilization process for the proposed device has been validated per ISO 11135 and the result demonstrated that sterilization method is valid. Therefore, this difference will not raise any safety issues.
14
| Item | Proposed Device
K213893 | Predicate Device 1
K192290 | Remark |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | FYA | FYA | Same |
| Regulation
No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for
Use | Surgical gown is intended to be worn
by operating room personnel during
surgical procedure to protect both the
surgical patient and the operating
room personnel from transfer of
microorganisms, body fluids, and
particulate material. | Surgical gown is intended to be worn
by operating room personnel during
surgical procedure to protect both the
surgical patient and the operating room
personnel from transfer of
microorganisms, body fluids, and
particulate material. | Same |
| | Per ANSI/AAMI PB70:2012 Liquid
barrier performance and classification
of protective apparel and drapes
intended for use in health care
facilities, the Level 3 Standard
Surgical Gown and level 3 Standard
Plus Surgical Gown met the
requirements for Level 3
classification. | Per ANSI/AAMI PB70:2012 Liquid
barrier performance and classification
of protective apparel and drapes
intended for use in health care
facilities, SMS Standard Surgical
Gown and SMS Surgical Gown with
Reinforcement met the requirements
for Level 3 classification. | Same |
| Style | Non-reinforced | Non-reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per
square (g) | $45g/m^2 +50 g/m^2, 50g/m^2;$ | $50g/m^2$ | Different |
| Size | M, L, XL, XXL, XXXL | M, L, XL, XXL, XXXL,
XXXL-XLONG | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic
pressure | >50 cm; | >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking
strength | ≥30N | cross direction: 61.17N
machine direction: 107.35N | Different |
| Tearing | >10N | cross direction: 19.71N | Different |
| Table5 General Comparison for level 3 standard surgical gown & level 3 standard plus |
|---|
| surgical gown of Safewear Gown |
15
| strength | machine direction: 62.28N | ||
|---|---|---|---|
| Seam strength | ≥30N | ≥30N | Same |
| Linting | Log1030 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier protection level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |
| Material | SMS nonwoven, Polyester, Polyamide; | SMS nonwoven, Polyester, Polyamide; | Same |
| Cytotoxicity | Under the conditions of the study, the | Under the conditions of the study, the | Same |
| Irritation | device is non-toxic, non-irritating, and | device is non-toxic, non-irritating, and | |
| Sensitization | non-sensitizing. | non-sensitizing. | |
| Sterilization | Sterile/Non-Sterile | ||
| Sterile Method: Ethylene Oxide (EO); | |||
| Sterilization Assurance Level (SAL): 10-6 | Sterile | ||
| Sterile Method: Ethylene Oxide (EO); | |||
| Sterilization Assurance Level (SAL): 10-6 | Different |
Different - Weight per square
The weight per square for the proposed surgical gowns is different from the predicate device K19290. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection requirements as required by PB70. Therefore, this difference will not raise any safety issues.
Different - Size
The size for the proposed surgical gowns is different from the predicate device K192290. The proposed surgical gowns are available in 5 product sizes, including M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Breaking Strength
The breaking strength for the proposed surgical gowns is different from the predicate device K192290. The proposed acceptance criteria not less than 30N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.
Different - Tearing strength
16
The tearing strength for the proposed surgical gowns is different from the predicate device K192290, the tearing strength of the proposed device is less than the predicate device. The proposed acceptance criteria not less than 10N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.
Different - Sterilization
The product status of the proposed device is different from the predicate device. The proposed device can be provided in sterile and non-sterile, and the predicate device is non-sterilized. However, although the predicate device is non-sterile, it shall be further sterilized prior to use. In addition, sterilization process for the proposed device has been validated per ISO 11135 and the result demonstrated that sterilization method is valid. Therefore, this difference will not raise any safety issues.
17
| Item | Proposed Device | Predicate Device 1 | Remark |
|---|---|---|---|
| K213893 | K192290 | ||
| Product Code | FYA | FYA | Same |
| Regulation | |||
| No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for | |||
| Use | Surgical gown is intended to be worn | ||
| by operating room personnel during | |||
| surgical procedure to protect both the | |||
| surgical patient and the operating | |||
| room personnel from transfer of | |||
| microorganisms, body fluids, and | |||
| particulate material. | |||
| Per ANSI/AAMI PB70:2012 Liquid | |||
| barrier performance and | |||
| classification of protective apparel | |||
| and drapes intended for use in health | |||
| care facilities, the Level 3 | |||
| Reinforced Surgical Gown and Level | |||
| 3 reinforced plus surgical gown met | |||
| the requirements for Level 3 | |||
| classification. | Surgical gown is intended to be worn by | ||
| operating room personnel during | |||
| surgical procedure to protect both the | |||
| surgical patient and the operating room | |||
| personnel from transfer of | |||
| microorganisms, body fluids, and | |||
| particulate material. | |||
| Per ANSI/AAMI PB70:2012 Liquid | |||
| barrier performance and classification of | |||
| protective apparel and drapes intended | |||
| for use in health care facilities, SMS | |||
| Standard Surgical Gown and SMS | |||
| Surgical Gown with Reinforcement met | |||
| the requirements for Level 3 | |||
| classification. | Same | ||
| Style | Reinforced | Reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per | |||
| square (g) | $45 g/m^2$ , $35g/m^2$ | $45g/m^2$ | Different |
| Size | M, L, XL, XXL, XXXL | M, L, XL, XXL, XXXL, XXXL-XLONG | Different |
| Flammability | Class I | Class I | Same |
| Hydrostatic | |||
| pressure | >50 cm; | >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking | |||
| strength | ≥30N | cross direction: 81.90N | |
| machine direction: 110.44N | Different | ||
| Tearing | >10N | cross direction: 25.32N | Different |
| strength | machine direction: 45.3N | ||
| Seam strength | ≥30N | ≥30N | Same |
| Linting | Log1030 ft³/min/ft² | >30 ft³/min/ft² | Same |
| Barrier | |||
| protection | |||
| level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |
| Material | SMS nonwoven, Polyester, Polyamide, LOCTITE LIOFOL LA 3720, PE breathable film; | SMS nonwoven, Polyester, Polyamide, LOCTITE LIOFOL LA 3720, PE breathable film; | Same |
| Cytotoxicity | Under the conditions of the study, the device is non-toxic, | Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing. | Same |
| Irritation | non-irritating, and non-sensitizing. | ||
| Sensitization | |||
| Sterilization | Sterile/Non-Sterile | ||
| Sterile Method: Ethylene Oxide (EO); | |||
| Sterilization Assurance Level (SAL): 10-6 | Sterile | ||
| Sterile Method: Ethylene Oxide (EO); | |||
| Sterilization Assurance Level (SAL): 10-6 | Different |
General Comparison for level 3 reinforced surgical gown & Level 3 reinforced Table6 plus surgical gown of Safewear Gown
18
Different - Weight per square
The weight per square for the proposed surgical gowns is different from the predicate device K19299. However, the difference in the weight per square will not affect the intended use. In addition, the performance testing results demonstrated that the proposed surgical gowns can meet the barrier protection requirements as required by PB70. Therefore, this difference will not raise any safety issues.
Different - Size
The size for the proposed surgical gowns is different from the predicate device K192290. The proposed surgical gowns are available in 5 product sizes, including M, L, XL, XXL and XXXL. However, the difference in the size will not affect the device performance. Different size can be selected by surgeon's condition. Therefore, this difference will not affect the safety and effectiveness of the proposed device.
Different - Breaking Strength
The breaking strength for the proposed surgical gowns is different from the predicate device K19299. The proposed acceptance criteria not less than 30N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.
19
Different - Tearing strength
The tearing strength for the proposed surgical gowns is different from the predicate device K192290, the tearing strength of the proposed device is less than the predicate device. The proposed acceptance criteria not less than 10N was sourced from ASTM F2407. In addition, the test result demonstrated the proposed device can meet the acceptance criteria. Therefore, this difference will not raise any safety issues.
Different – Sterilization
The product status of the proposed device is different from the predicate device. The proposed device can be provided in sterile and non-sterile, and the predicate device is non-sterilized. However, although the predicate device is non-sterile, it shall be further sterilized prior to use. In addition, sterilization process for the proposed device has been validated per ISO 11135 and the result demonstrated that sterilization method is valid. Therefore, this difference will not raise any safety issues.
20
10. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate devices K172987 and K192290.