(148 days)
Not Found
No
The 510(k) summary describes a disposable surgical gown and its physical barrier properties. There is no mention of AI, ML, image processing, or any software-driven functionality. The performance studies focus on material properties and barrier standards.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is a surgical gown, used for protection and to prevent the transfer of microorganisms, not for treatment.
No
The device is a disposable surgical gown intended to protect against microorganisms and fluids during surgical procedures, not to diagnose a medical condition.
No
The device is a physical surgical gown made of materials like poly-reinforced fabric and PP/PE composite film, and its performance is evaluated through physical tests, not software-based metrics.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Intended Use: The intended use of the Disposable Surgical Gowns is to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate matter during surgical procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical characteristics and barrier performance of the gown.
- Lack of Diagnostic Elements: There is no mention of analyzing biological specimens, providing diagnostic information, or using any in vitro techniques.
The device described is a Class II medical device (based on the predicate device K170762, which is a Class II surgical gown) intended for infection control and barrier protection in a surgical setting.
N/A
Intended Use / Indications for Use
The Disposable 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 matter. In addition, 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). This is a single use, disposable device, provided sterile.
Product codes (comma separated list FDA assigned to the subject device)
FYA
Device Description
The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite breathable film. The proposed device is available in four different sizes, include M, L, XL,TL. The proposed devices can meet the requirements for Level 3 per ANSVAAMI PB70:2012. The proposed devices are disposable medical devices and provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel / operating room
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 subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.
Key Results:
- AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities: Level 3
- ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure: PASS (72/59N)
- ASTM D5034-21, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test): PASS (99/81N)
- ASTM D1683M-17 Standard Test Method for Failure in Sewn Seams of Woven Fabrics: PASS (Sleeve Seam:68.3N, Side Seam:69.7N, Belt Seam:71N)
- AATCC 42-2013, Water Penetration Resistance: Impact Penetration Test: PASS (0~0.019 g)
- Evaporative Resistance ASTM F1868-17: PASS (2.46 Pa.m²/W.)
- AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test: PASS (52~290 cm)
- CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles: PASS (Class I)
- ISO 9073- 10:2003(E) Lint and Other Particles Generation: PASS (3.0)
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization: PASS (non-irritating, and non-sensitizing)
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity: PASS (non-cytotoxic)
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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 11, 2022
Suzhou JaneE Medical Technology Co., Ltd % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 14 th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K212591
Trade/Device Name: Disposable Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 8, 2021 Received: December 8, 2021
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.
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,
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) K212591
Device Name Disposable Surgical Gown
Indications for Use (Describe)
The Disposable 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 matter. In addition, 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). This is a single use, disposable device, provided 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 K212591
A. Applicant:
Suzhou JaneE Medical Technology Co., Ltd. Address: No.339 HuaFeng Road, New District, Suzhou, Jiangsu Province, China, 215129 Contact person: Mr. Zhu Li Tel: +86 13951116714 Email: zhuli@sz-dk.cn
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050
Email: fda.sungo@gmail.com
B. Device:
Trade Name: Disposable Surgical Gown Common Name: Surgical Gown Model(s): Reinforced
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:
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical
4
Suzhou JaneE Medical Technology Co., Ltd. No.339 HuaFeng Road, New District, Suzhou, Jiangsu Province, China, 215129
procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. This is a single use, disposable device, provided sterile.
E. Device Description:
The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite breathable film. The proposed device is available in four different sizes, include M, L, XL,TL. The proposed devices can meet the requirements for Level 3 per ANSVAAMI PB70:2012. The proposed devices are disposable medical devices and provided sterile.
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Manufacturer | Suzhou JaneE Medical | ||
| Technology Co., Ltd. | Cardinal Health™ | - | |
| 510K number | K212591 | K170762 | - |
| Product Name | Disposable Surgical Gown | Cardinal Health™ Non- | |
| Reinforced Surgical Gown | - | ||
| Classification | Class II Device, FYA (21 | ||
| CFR878.4040) | Class II Device, FYA (21 | ||
| CFR878.4040) | Same | ||
| Intended Use | The Disposable 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 | |||
| matter. In addition, 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 | Cardinal Health™ Non- | ||
| Reinforced Surgical Gown is | |||
| 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. In addition, 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 | |||
| Cardinal Health™ Non- | |||
| Reinforced Surgical Gowns are | |||
| single use, disposable medical | Same | ||
| (AAMI PB70). This is a | |||
| single use, disposable | |||
| device, provided sterile. | devices; provided sterile and | ||
| non-sterile. | |||
| Material | |||
| Composition | Polyolefin | ||
| (Polypropylene) SMS | |||
| nonwoven | Polyolefin (Polypropylene) | ||
| SMS nonwoven | Same | ||
| Sterility | Sterile | Sterile and non-sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | Blue | Same |
| Size | M,L,XL,TL | M-S, M, L, XL, XXL | Similar. No |
| effect on | |||
| safety or | |||
| efficacy | |||
| Weight per | |||
| square(g) | Critical Area: 87.8g/m² | ||
| Non-Critical Area: | |||
| 45.12g/m² | 31g/m² (1.32 oz/yd²) | Similar. No | |
| effect on | |||
| safety or | |||
| efficacy. | |||
| Both passed | |||
| performance | |||
| tests. | |||
| Tensile | MD: 16.18 lbs (72N) CD: | ||
| 13.26 lbs (59N) | MD Mean 21.57 lbs CD Mean | ||
| 13.6 lbs | Similar. No | ||
| effect on | |||
| safety or | |||
| efficacy. | |||
| Both passed | |||
| performance | |||
| tests. | |||
| Tear | MD:22.25 lbs (99 N) | ||
| CD:18.20 lbs (81N) | MD Mean 3.47 lbs CD Mean | ||
| 5.63 lbs | Similar. No | ||
| effect on | |||
| safety or | |||
| efficacy. | |||
| Both passed | |||
| performance | |||
| tests. | |||
| Seam Strength | Sleeve Seam:68.3N | ||
| Side Seam:69.7N | |||
| Belt Seam:71N | No available | Similar. No | |
| effect on | |||
| safety or | |||
| efficacy. | |||
| Both passed | |||
| performance | |||
| tests. | |||
| Hydrostatic | |||
| Pressure(cm) | |||
| AATCC-127 | >50 cm | >50 cm | Same |
| Water Impact (g) | |||
| AATCC-42 | ≤1.0 g | ≤1.0 g | Same |
| 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. | | Same |
F. Comparison with predicate device
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6
Suzhou JaneE Medical Technology Co., Ltd. No.339 HuaFeng Road, New District, Suzhou, Jiangsu Province, China, 215129
7
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.
| Test Methodology | Test Methodology
Purpose | Acceptance Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| AAMI/ANSI
PB70:2012, Liquid
Barrier Performance
and Classification of
protective Apparel and
Drapes Intended For
Use In Health Care
Facilities. | The tests were
performed to determine
the classification of
subject surgical gown
product. | N/A | Level 3 |
| ASTM D5587-15,
Standard Test Method
for Tearing Strength of
Fabrics by Trapezoid
Procedure | The test was performed
in accordance with
ASTM D5587:
2015(2019) Standard
Test Method for
Tearing Strength of
Fabrics by Trapezoid
Procedure to evaluate
the tearing strength of
the test sample. | >30N | PASS
72/59N
(Average result from 3
nonconsecutive batches) |
| ASTM D5034-21,
Standard Test Method
for Breaking Strength
and Elongation of
Textile Fabrics (Grab
Test) | The test was performed
In accordance with
ASTM D5034-21.
Standard. Test Method
for Breaking Strength
and Elongation of
Textile Fabrics (Grab
Test) to evaluate the
breaking strength of the
test sample. | >10N | PASS
99/81N
(Average result from 3
nonconsecutive batches) |
| ASTM D1683M-17
Standard Test Method
for Failure in Sewn
Seams of Woven
Fabrics. | The test was performed
In accordance with
ASTM D1683M-17
Standard. Test Method
for Seam Strength of
Textile Fabrics (Grab
Test) to evaluate
Failure in Sewn Seams
of the test sample. | >30N | PASS
Sleeve Seam:68.3N
Side Seam:69.7N
Belt Seam:71N
(Average result from 3
nonconsecutive batches) |
| | | | |
| AATCC 42-2013,
Water Penetration
Resistance: Impact
Penetration Test; | The test was performed
in accordance with
AATCC 42: 2013
Water Resistance:
Impact Penetration Test
to evaluate the water
impact of the test
sample. | ≤1.0 g | PASS
00.019 g290 cm
(Average result from 3
nonconsecutive batches) |
| Evaporative Resistance
ASTM F1868-17 | The test was performed
in accordance with
ASTM F1868-17 to
evaluate the
Evaporative Resistance
of the test samples | 50 cm | PASS
52
(Average result from 3
nonconsecutive batches) |
| CPSC 16 CFR Part
1610-2008, Standard
for the Flammability of
clothing textiles | 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 Class I
requirements | PASS
Class I
(Average result from 3
nonconsecutive batches) |
| ISO 9073- 10:2003(E)
Lint and Other Particles
Generation | The test was performed
in accordance with ISO
9073-10: 2003 Textiles-
Test Methods for
Nonwovens-Part 10:
Lint and Other Particles
Generation in the Dry
State to evaluate the
linting of the test
sample. | Log10(particle count)