(266 days)
Not Found
No
The 510(k) summary describes a physical barrier device (isolation gown) and its performance testing against established standards. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device is a surgical isolation gown intended to protect healthcare personnel from microorganisms, body fluids, and particulate material, not to provide therapy.
No
The device is a surgical isolation gown intended to protect healthcare personnel from microorganisms, body fluids, and particulate material. Its purpose is protective, not diagnostic.
No
The device description clearly states the device is constructed of polyolefin (Polypropylene) SMS nonwoven material and is a physical gown, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "protect health care personnel from the transfer of microorganisms, body fluids and particulate material." This describes a barrier device for personal protection, not a device used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the material, construction, and barrier performance of a gown. This aligns with a protective garment, not an IVD.
- Performance Studies: The performance studies mentioned relate to barrier performance and biocompatibility (cytotoxicity, irritation, sensitization), which are relevant for a protective gown, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
Therefore, the information clearly indicates that this device is a protective medical garment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Gown is a single use, disposable medical nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FYC
Device Description
The proposed SURGICAL Isolation Gown is constructed of polyolefin (Polypropylene) SMS nonwoven material with the color in yellow. The SURGICAL Isolation Gowns consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings. The product has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device was tested for barrier performance per ANSI/AAMI PB70:2012. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.
The test was done against ISO10993-5 and ISO10993-10. The result indicates the gown is noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-1.
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.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
February 15, 2018
Jingzhou Haixin Green Cross Medical Products Co., Ltd % Raymond Luo Technical Manager Shanghai Sungo management Consulting Company Limited 4th Floor, 1500# Central Avenue Shanghai, 200122 China
Re: K171535
Trade/Device Name: Surgical Isolation Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: January 9, 2018 Received: January 11, 2018
Dear Raymond Luo:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171535
Device Name SURGICAL ISOLATION GOWN
Indications for Use (Describe)
The Surgical Isolation Gown is intended to protect health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).The Surgical Isolation Gown is a single use, disposable medical nonsterile.
| 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
K 171535 Date of preparation: 2018-1-25
A. Applicant:
Name: Jingzhou Haixin Green Cross Medical Products Co., Ltd
Address: Room 916-918, Floor 9, International Finance Center, No.296, Xinhua Road, Wuhan City, Hubei Province, China
Official Contact Person Information
Name: Raymond Luo Tel: 0086-21-68828050 Mail: fda.sungo@gmail.com Shanghai Sungo Management Consulting Co., Ltd.
B. Device:
The proprietary name of the new device: SURGICAL ISOLATION GOWN Common Name: Isolation Gown Classification Name: Surgical Isolation Gown Classification regulation: 21 CFR 878.4040 Classification: Class II. Regulation Name: Surgical Apparel Product code: FYC
C. Predicate device:
K160339 Cardinal Health™ Isolation Gown Cardinal Health 200, LLC
D. Indications for use:
The Surgical Isolation Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Gown is a single use, disposable medical device provided non-sterile.
E. Device Description
The proposed SURGICAL Isolation Gown is constructed of polyolefin (Polypropylene) SMS nonwoven material with the color in yellow. The SURGICAL Isolation Gowns consist of a one critical zone throughout the entire gown including seams but excluding cuffs, hems, and bindings. The product has been tested for barrier performance per ANSI/AAMI PB70:2012. Testing was performed according to the
4
Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met AATCC-42/AATCC-127, and meets AAMI PB70:2012 Level 3 requirements.
Image /page/4/Figure/1 description: The image shows a diagram of a garment with various measurements labeled. The diagram includes labels such as A, B, C, D, E, F, G, H, and I, each pointing to a specific dimension of the garment. The garment appears to be a long-sleeved shirt or robe, and the measurements likely indicate the size and fit of the garment.
| Size | Measurement Location (cm) | |||||||
|---|---|---|---|---|---|---|---|---|
| A | B | C | D | E | F | G | H/I | |
| Universal | 119 | 138 | 22 | 62 | 31 | 7.5 | 13 | 24 |
| XL | 125 | 146 | 24 | 68 | 33 | 7.5 | 14.5 | 24.5 |
| XXL | 133 | 160 | 30 | 72 | 36 | 7.5 | 16 | 25 |
F. Comparison with predicate
5
| Device | K171535 | K160339 | Comparison |
|---|---|---|---|
| Manufacturer | Jingzhou Haixin Green Cross Medical | ||
| Products Co., Ltd | Cardinal Health 200, LLC | NA | |
| Model Name | SURGICAL ISOLATION GOWN | Cardinal Health™ | NA |
| Classification | Class II Device, FYC (21 | ||
| CFR878.4040) | Class II Device, FYC (21 | ||
| CFR878.4040) | Same | ||
| Intend use | The Surgical Isolation Gown is | ||
| intended to protect health care patients | |||
| and health care personnel from the | |||
| transfer of microorganisms, body fluids | |||
| and particulate material. Not intended | |||
| for use in the operating room. In | |||
| addition, the Surgical Isolation Gown | |||
| meets the requirements of an AAMI | |||
| Level 3 barrier protection for an | |||
| isolation gown per ANSI/AAMI | |||
| PB70:2012 Liquid Barrier Performance | |||
| and Classification of Protective Apparel | |||
| Drapes Intended for Use in Health Care | |||
| Facilities (ANSI/AAMI PB70). The | |||
| Surgical Isolation Gown is a single use, | |||
| disposable medical device provided | |||
| non-sterile. | Cardinal Health Isolation Gown is | ||
| intended to protect health care patients | |||
| and health care personnel from the transfer of | |||
| microorganisms, body fluids and | |||
| particulate material. Not intended for | |||
| use in the operating room. In addition, | |||
| The Cardinal Health Isolation Gown | |||
| meets the requirements of an AAMI | |||
| Level 3 barrier protection for an | |||
| isolation gown per ANSI/AAMI | |||
| PB70:2012 Liquid Barrier | |||
| Performance and Classification of | |||
| Protective Apparel and Drapes | |||
| Intended for Use in Health Care | |||
| Facilities (ANSI/AAMI PB70). The | |||
| Cardinal Health Isolation | |||
| Gown is a single use, disposable medical | |||
| device provided non-sterile. | Similar |
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| Description | The Surgical Isolation Gown is a
surgical isolation gown with moderate
barrier protection identified by
Regulation 21 CFR 878.4040 under
FDA product code, FYC. The Surgical
Isolation Gown is a single use,
disposable medical device provided
non-sterile. The Surgical Isolation
Gown is offered in yellow with three
sizes. Each model is constructed of a
non-woven material and has been tested
according to ANSI/AAMI PB70:2012
Liquid Barrier Performance and
Classification of Protective Apparel and
Drapes Intended for Use in Health Care
Facilities and meets AAMI Level 3. | The Surgical Isolation Gown is a
surgical isolation gown with moderate
barrier protection identified by
Regulation 21 CFR 878.4040 under
FDA product code, FYC. The Surgical
Isolation Gown is a single use,
disposable medical device provided
non-sterile. The Surgical Isolation
Gown is offered in two color (blue and
yellow) models and each model is
offered in two sizes for a total of four
models. Each model is constructed of a
non-woven material and has been
tested according to ANSI/AAMI
PB70:2012 Liquid Barrier
Performance and Classification of
Protective Apparel and Drapes
Intended for Use in Health Care
Facilities and meets AAMI Level 3. | Similar |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Material | Polypropylene SMS non woven | Polypropylene SMS non woven | Same |
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| Composition | |||
|---|---|---|---|
| Design | Medical Tape Neck Closure | Medical Tape Neck Closure | Same |
| Features | White Belt Tie | ||
| Snap fastener | White Belt Tie | ||
| Elastic Cuffs | |||
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Color | Yellow | Blue and Yellow | Similar |
| Element of Comparison | K171535 | K160339 | Comparison |
|---|---|---|---|
| Basis weight (oz/yd2) | |||
| ASTM D3776 | Testing not performed | Mean = 1.21 | |
| Ind Min = 1.19 | |||
| Ind Max = 1.23 | NA | ||
| Grab tensile MD (lb) | |||
| ASTM D5034 | Mean = 20.71 | ||
| Ind Min = 19.73 | |||
| Ind Max = 21.87 | Mean = 24.38 | ||
| Ind Min = 21.94 | |||
| Ind Max = 26.28 | Similar | ||
| Grab tensile CD (lb) | |||
| ASTM D5034 | Mean = 12.21 | ||
| Ind Min = 11.20 | |||
| Ind Max = 14.11 | Mean = 14.54 | ||
| Ind Min = 12.70 | |||
| Ind Max = 16.45 | Similar | ||
| Trap Tear MD, (lbs) | |||
| ASTM D5587-15 Highest Peak | Mean = 3.48 | ||
| Ind Min = 2.82 | |||
| Ind Max = 3.93 | Mean = 4.74 | ||
| Ind Min = 3.67 | |||
| Ind Max = 5.47 | Similar | ||
| Trap Tear CD, (lbs) | |||
| ASTM D5587-15 Highest Peak | Mean = 7.15 | ||
| Ind Min = 6.20 | |||
| Ind Max = 7.70 | Mean = 9.24 | ||
| Ind Min = 7.54 | |||
| Ind Max = 12.98 | Similar | ||
| Flammability CPSC, Part 1610 | Class I | Class I | Same |
| Hydrostatic Head (cm) | |||
| AATCC 127 | CHEST/BACK/SLEEVE: | ||
| Mean = 69 | |||
| Ind Min = 54 | |||
| Ind Max = 84 | Body/Sleeve: | ||
| Mean = 69 | |||
| Ind Min = 56 | |||
| Ind Max = 84 | Similar | ||
| Water Impact (g) | |||
| AATCC-42 (performed with | |||
| water per AATCC42:2013) | Sleeve Seams: | ||
| Mean = 0.04 | |||
| Ind Min = 0.02 | |||
| Ind Max = 0.08 |
CHEST:
Mean = 0.04
Ind Min = 0.02
Ind Max = 0.05
Back:
Mean = 0.05
Ind Min = 0.04
Ind Max = 0.07 | N/A
Body/Sleeve:
Mean = 0.08
Ind Min = 0.05
Ind Max = 0.13 | Similar |
| Liquid Barrier Performance | Device was tested in | Device was tested in | Same |
| Classification Properties | accordance with
ANSI/AAMI PB70:2012
and meets Level 3
requirements for an
isolation gown. The critical
zone areas tested were the
chest, the back, the sleeve
seam, the belt seam and side
seam. | accordance with
ANSI/AAMI PB70:2012
and meets Level 3
requirements for an
isolation gown. The critical
zone areas tested were the
body and sleeve (same
fabric), the sleeve seam,
front belt or tie attachment,
and the front seam arm
attachment using multiple
lots. | |
| Biocompatibility | The test was done against
ISO10993-5 and
ISO10993-10. The result
indicates the gown is
noncytotoxic, non-irritating,
and non-sensitizing per ISO
10993-1. | Under the conditions of
each study, the Cardinal
HealthTM Isolation gown is
noncytotoxic, non-irritating,
and non-sensitizing per ISO
10993-1. | Same |
| Sterilization Modality | None (Non-Sterile) | None (Non-Sterile) | Same |
| Lint and other particles
generated in dry state | SIDE A: OUTSIDE
TOTAL >0.3 1024
TOTAL >0.5 658
SIDE B: INSIDE
TOTAL >0.3 1066
TOTAL >0.5 697 | Performance values not
available in predicate
510(k) submission | NA |
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G. Summary of Non-clinical tests
The SURGICAL Isolation gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, material composition, and configuration/dimensions. Under the conditions of each study, the SURGICAL Isolation gown is non-cytotoxic, nonirritating, and non-sensitizing per ISO-10993 and have met the requirements of ANSVAAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for an AAMI Level 3 isolation gown.
H. Conclusion
The Surgical Isolation Gowns are as safe, as effective and performs as well as the legally marketed device identified in this submission.