(163 days)
Not Found
No
The device description and performance studies focus on material properties and barrier protection, with no mention of AI or ML.
No.
A surgical gown is purely a barrier device, not intended to diagnose, cure, mitigate, treat, or prevent disease.
No
Explanation: The device is a surgical gown intended to protect personnel and patients from the transfer of microorganisms and fluids during surgical procedures. Its purpose is protective, not diagnostic.
No
The device is a physical surgical gown made of non-woven fabric, not software. The description details material properties and physical testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the surgical gowns are for protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical properties of the material and its barrier capabilities. There is no mention of analyzing samples from the human body or providing information for diagnosis.
- Performance Studies: The performance studies listed are related to the physical properties and barrier performance of the gown (water resistance, strength, flammability, etc.). There are no studies related to diagnostic accuracy or the analysis of biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting specific substances or markers
- Providing information for diagnosis, monitoring, or screening
In summary, the surgical gown is a barrier device used in a clinical setting, not a device used to perform tests on samples taken from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
Surgical Gown is designed for the medical personnel using in operation. The employed material is SMS compound non-woven fabric. The material has many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff,they don't have any peculiar smell,other matters. The Surgical gowns are for safe use in the operating room environment, i.e., lint free, free of toxic ingredients and non-fast dyes. It is a kind of Non- Reinforced surgical gown.
The chest front and sleeve critical zone of the Surgical Gown are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical Gown is a single use, disposable medical device that will be provided 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
Operating room personnel / health care facilities
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. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards:
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics A (Grab Test);
ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by TrapezoidProcedure;
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Appareland A 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
ISO9073-10-2003 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state
ASTM D1683/D1683M-17(2018)Standard Test Method for Failure in Sewn Seams of Woven Fabrics
AATCC42-2017 (Water Resistance: Impact penetration): ≤1.0g, Result: Pass
AATCC 127-2018 (Water Resistance: hydrostatic pressure): ≥50 cmH2O, Result: Pass
ASTM D1683/D1683M-2017(R2018) (Seam strength (sleeve seam)): ≥20N(4.5lbf), Result: Pass
ASTM D5587-15(2019), Tensile Testing Machine, CR (Tensile strength): ≥20N(4.5lbf), Result: Pass
ASTM D5034-09(2017), 1-in Grab Test, Tensile Testing Machine, CRE (Tear strength): ≥20N, Result: Pass
ASTM F 1868-2017, Procedure Part B (Evaporative Resistance Of Clothing Materials): ≥30cmH2O (0.00294Kpa), Result: Pass
ISO 9073-10:2004 (Lint and other particles generation in the dry state(material)): Critical area≤4.0 Less critical area≤4.0, Result: Pass
16 CFR Part 1610 (Flammability): Class I, Result: Pass
Further, biocompatibility tests showed:
Cytotoxicity: No cytotoxic
Irritation: No irritating
Sensitization: No sensitizing
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 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-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 24, 2021
Hubei Wanli Protective Products Co. Ltd Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, Shanghai 200122 China
Re: K211509
Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 24, 2021 Received: September 24, 2021
Dear Eva Li:
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.
For Clarence W. Murray, III, PhD 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) K211509
Device Name Surgical Gown (Model: WLG1002-L3)
Indications for Use (Describe)
Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/A AMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
A. Applicant
Hubei Wanli Protective Products Co.ltd. Address: Tangwan Street ,Xiliuhe Town,Xiantao ,Hubei,China
Contact Person: Andy Wen Tel: 0086-728-3227299 Fax: 0086-728-3223799 Email: sale01@hbwanli.com
Prepared Date: Oct 22nd , 2021 Submission
Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com
Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device
Trade Name: Surgical Gown Common Name: Surgical Gown Model: WLG1002-L3
- Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K170762 Cardinal Health™ Non-Reinforced Surgical Gown Cardinal Health 200, LLC
D. Intended use of the device:
Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to
4
protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Surgical Gowns are single use, disposable medical devices; provided non-sterile.
E. Device Description:
Surgical Gown is designed for the medical personnel using in operation. The employed material is SMS compound non-woven fabric. The material has many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff,they don't have any peculiar smell,other matters. The Surgical gowns are for safe use in the operating room environment, i.e., lint free, free of toxic ingredients and non-fast dyes. It is a kind of Non- Reinforced surgical gown.
The chest front and sleeve critical zone of the Surgical Gown are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical Gown is a single use, disposable medical device that will be provided of non-sterile packaging configurations.
F. Technological Characteristics Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | Hubei Wanli Protective Products | ||
| Co.ltd. | Cardinal Health™ | — | |
| 510(K) number | K211509 | K170762 | — |
| Model Name | Surgical Gown | Cardinal Health™ Non-Reinforced | |
| Surgical Gown | — | ||
| Classification | Class II Device, FYA (21 | ||
| CFR878.4040) | Class II Device, FYA (21 | ||
| CFR878.4040) | Same | ||
| Intend use | Surgical Gown are intended to be | ||
| worn by operating room personnel | |||
| during surgical procedures to | |||
| protect the surgical patient and | |||
| operating room personnel from the | |||
| transfer of microorganisms, body | |||
| fluids and particulate material. This | |||
| surgical gown meets the | |||
| requirements of AAMI Level 3 | |||
| barrier protection for a surgical | |||
| gown per ANSI/AAMI PB70:2012 | |||
| Liquid barrier performance and | |||
| classification of protective apparel | |||
| and drapes intended for use in | |||
| health care facilities (AAMI PB70). | Surgical Gown are intended to be | ||
| worn by operating room personnel | |||
| during surgical procedures to protect the surgical | |||
| patient and operating room | |||
| personnel from the transfer of | |||
| microorganisms, body fluids and | |||
| particulate material. This surgical | |||
| gown meets the requirements of | |||
| AAMI Level 3 barrier protection | |||
| for a surgical gown per | |||
| ANSI/AAMI PB70:2012 Liquid | |||
| barrier performance and | |||
| classification of protective | |||
| apparel and drapes intended for | same |
5
| | Tangwan Street ,Xiliuhe Town,Xiantao ,Hubei,China
The Surgical Gowns are single use,
disposable medical devices;
provided non-sterile. | use in health care facilities (AAMI
PB70). The Surgical Gowns are
single use, disposable medical
devices; provided non-sterile. | |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Material
Composition | Sleeve/body (polyethylene SMS
Nonwoven) | Polyolefin (Polypropylene)
SMS nonwoven | Same |
| Color | Blue | Blue | same |
| Size | S,M,L,XL,XXL | M-S, M, L, XL, XXL | Similar |
| Sterility | Non-Sterile | Non-Sterile | same |
| Use | Single Use; Disposable | Single Use; Disposable | same |
| Weight per
square(g) | 45.9 g/m² | 31g/m² (1.32 oz/yd2) | Similar |
| Resistance to
blood and liquid
penetration | Level 3 AAMI PB70 | Level 3 AAMI PB70 | same |
| Biocompatibility | Under the conditions of the study,
the device extract was not
cytotoxic. Under the conditions of
the study, the non-polar and polar
device extracts were not found to be
an irritant.
Under conditions of the study, the
non-polar and polar device extracts
were not found to be a sensitizer. | Under the conditions of the study,
the device extract was not
cytotoxic. Under the conditions of
the study, the non-polar and polar
device extracts were not found to
be an irritant.
Under conditions of the study,
the non-polar and polar device
extracts were not found to be a
sensitizer. | same |
| Sterilization
Modality | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
Table 2 performance test
| Performance | Lot#20210110 | Lot#20210112 | Lot#20210114 | |
|---|---|---|---|---|
| Impact penetration | ||||
| AATCC42-2017 | ||||
| (≤1.0g) | Front | 0.2 | 0.1 | 0.2 |
| Back | 0.2 | 0.2 | 0.1 | |
| Sleeve seams | 0.2 | 0.1 | 0.2 | |
| Side seams | 0.2 | 0.2 | 0.1 | |
| Belt Seam | 0.1 | 0.1 | 0.1 | |
| hydrostatic pressure | ||||
| AATCC 127-2018 | ||||
| (≥50 cmH2o) | Front | 74.10 | 73.08 | 73.15 |
| Back | 70.19 | 71.66 | 71.53 | |
| Sleeve seams | 70.95 | 70.34 | 70.89 | |
| Side seams | 73.99 | 75.72 | 77.10 | |
| Belt Seam | 56.10 | 56.62 | 58.98 |
6
| Tangwan Street, Xinlune Town, Xiantao, Hubei, China | |||
|---|---|---|---|
| Testing item | Shoulder | Armhole | Sleeve |
| Seam strength(mean) | 71.8N | 66.0N | 77.0N |
| Testing Item | Mean |
|---|---|
| Tensile strength, MD* | 27.8 IBS |
| Tensile strength, CD* | 19.1 IBS |
| Tear strength, MD* | 10.7 IBS |
| Tear strength, CD* | 6.24 IBS |
| Weight per Unit Area | 45.9g/m2 |
| Evaporative Resistance Of Clothing Materials | Mean |
|---|---|
| Evaporative Resistance (Ret) | 0.0052 kPa.m²/W |
| Intrinsic Evaporative Resistance (Ref) | 0.0018 kPa.m²/W |
| Lint | And | Other | Particles
Generation In The Dry State | A:Face | B: Face |
|-----------------|-----|-------|------------------------------------------|--------|---------|
| Material(Md) | | | | 2.2 | 2.4 |
| Material(Uq) | | | | 2.3 | 2.5 |
| Sleeve seam(Md) | | | | 2.2 | 2.4 |
| Sleeve seam(Uq) | | | | 2.3 | 2.4 |
Table3 Biocompatibility Comparison
| Item | Proposed device | Acceptance
Criteria | Result |
|---------------|------------------------------------------------------------------------|------------------------|----------------|
| Cytotoxicity | Under the conditions of
the study, the device is
non-cytotoxic. | Non-Cytotoxic | No cytotoxic |
| Irritation | Under the conditions of
the study, the device is
non-irritating. | Non-Irritating | No irritating |
| Sensitization | Under the conditions of
the study, the device is
non-sensitizing | Non-Sensitizing | No sensitizing |
G. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoint safe levels using the following standards:
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And
7
Skin Sensitization
A CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics A (Grab Test);
-
A ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by TrapezoidProcedure;
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Appareland A Drapes Intended For Use In Health Care Facilities. -
A ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
-
ISO9073-10-2003 Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state
-
ASTM D1683/D1683M-17(2018)Standard Test Method for Failure in Sewn Seams of Woven Fabrics
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| AATCC42-2017 | Water Resistance: | ||
| Impact penetration | ≤1.0g | Pass | |
| AATCC 127-2018 | Water Resistance: | ||
| hydrostatic pressure | ≥50 cmH2O | Pass | |
| ASTM D1683/D1683M- | |||
| 2017(R2018) | Seam strength | ||
| (sleeve seam) | ≥20N(4.5lbf) | Pass | |
| ASTM D5587-15(2019), | |||
| Tensile Testing Machine, | |||
| CR | Tensile strength | ≥20N(4.5lbf) | Pass |
| ASTM D5034-09(2017), 1- | |||
| in Grab Test, Tensile | |||
| Testing Machine, CRE | Tear strength | ≥20N | Pass |
| ASTM F 1868-2017, | |||
| Procedure Part B | Evaporative Resistance Of | ||
| Clothing Materials | ≥30cmH2O (0.00294Kpa) | Pass | |
| ISO 9073-10:2004 | Lint and other particles | ||
| generation in the dry | |||
| state(material) | Critical area≤4.0 | ||
| Less critical area≤4.0 | Pass | ||
| 16 CFR Part 1610 | Flammability | Class I | Pass |
H. Summary of Clinical Performance Test
No clinical study is included in this submission.
I. Conclusion
The conclusions drawn fromthe nonclinical tests performed demonstrate thatthe subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Cardinal Health™ Non-Reinforced Surgical Gown cleared under K170762.