(311 days)
The 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 Surgical Gown meets the requirements for Level 3 classification.
The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gowns is to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
The proposed devices have a SMS design that provides a PB70:2012 level 3 Liquid Barrier Performance Barrier.
The proposed devices are single use, disposable medical devices and can be provided in nonsterile. These surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL.
This document is a 510(k) summary for a surgical gown, not an AI/ML device. Therefore, the requested information regarding AI/ML device performance criteria, study design, expert involvement, and ground truth establishment is not applicable.
The document describes the acceptance criteria and the study proving the device meets these criteria for a Surgical Gown (Model: surgical gown-hp-3).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria (Predicate Device K202706 or Standard) | Reported Device Performance (surgical gown-hp-3) | Remark (for comparison to predicate) |
|---|---|---|---|---|
| Performance | ||||
| Water Resistance (Imp. Pen.) | AATCC TM42-2017e | ≤1.0g | ≤1.0g (Pass) | Same / Meet standard requirement |
| Water Resistance (Hydro. Res.) | AATCC 127 - 2017 (2018) | ≥50cm | ≥50m (Pass, Meet level 3 requirement) | Same / Meet standard requirement |
| Tensile Strength | ASTM D5034-09(2017) | ≥30N(7 lbf) | Pass (≥30N(7 lbf)) | Meet standard requirement (See Note 2) |
| Tearing Strength | ASTM D5733-1999 | ≥10N(2.3 lbf) | Pass (≥10N(2.3 lbf)) | Meet standard requirement (See Note 2) |
| Seam Strength | ASTM D1683/D1683M-2011 | ≥30N(7 lbf) | Pass (≥30N(7 lbf)) | Meet standard requirement (See Note 2) |
| Flammability | 16 CFR Part 1610 | Class 1 | Class 1 (Pass) | Same |
| Biocompatibility | ||||
| Cytotoxicity | ISO 10993-5:2009 | No Cytotoxicity (under conditions of study) | Pass - Non-toxic | Same |
| Skin Sensitization | ISO 10993-10:2010 | No Irritation / Non-sensitizing (under conditions of study) | Pass - No Irritation / Non-sensitizing | Same |
| Skin Irritation | ISO 10993-10:2010 | No Sensitization / Non-irritating (under conditions of study) | Pass - No Sensitization / Non-irritating | Same |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test. It refers to compliance with standards like ANSI/AAMI PB70:2012, ASTM F2407-20, ISO 10993-5, and ISO 10993-10, which would dictate the number of test samples required by those standards.
The data provenance is not explicitly stated as "country of origin," but the submitter (Weihai Dishang Medical Technology Co., Ltd) is located in Weihai, Shandong, China. The studies are non-clinical (laboratory tests), not patient-based data. These are prospective tests conducted on the device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical medical device (surgical gown), not an AI/ML diagnostic or predictive device requiring expert review for ground truth. The "ground truth" here is established by the specifications and measurement methodologies defined in the referenced standards (e.g., AATCC, ASTM, ISO).
4. Adjudication method for the test set
Not applicable. This refers to laboratory testing against defined standards, not clinical assessment requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is for a physical medical device (surgical gown), not an AI/ML system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical medical device (surgical gown), not an AI/ML system.
7. The type of ground truth used
The "ground truth" is defined by the acceptance criteria specified in internationally recognized performance standards for surgical gowns. These include:
- ANSI/AAMI PB70:2012 (Liquid barrier performance and classification of protective apparel and drapes)
- ASTM F2407-20 (Standard Specification for Surgical Gowns)
- AATCC TM42-2017e (Water Resistance: Impact Penetration Test)
- AATCC 127 - 2017 (2018) (Water Resistance: Hydrostatic Pressure Test)
- ASTM D5034-09(2017) (Tensile Strength)
- ASTM D5733-1999 (Tearing Strength)
- ASTM D1683/D1683M-2011 (Seam Strength)
- 16 CFR Part 1610 (Flammability)
- ISO 10993-5:2009 (Biological evaluation - Cytotoxicity)
- ISO 10993-10:2010 (Biological evaluation - Irritation and skin sensitization)
8. The sample size for the training set
Not applicable. This is not an AI/ML product that uses a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML product.
{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 on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
December 16, 2021
Weihai Dishang Medical Technology Co., Ltd Ricky Xia Manager Room 406-409, Block C, No.213 Torch Road, Torch High-tech Industrial Development Zone Weihai, Shandong 264209 China
Re: K210355
Trade/Device Name: Surgical Gown, Model: surgical gown-hp-3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: December 10, 2021 Received: December 15, 2021
Dear Ricky Xia:
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) K210355
Device Name Surgical Gown, Model: surgical gown-hp-3
Indications for Use (Describe)
The 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 Surgical Gown meets the requirements for Level 3 classification.
The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gowns is to be sold to repackager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
| Type of Use (Select one or both, as applicable) | For the Non-Health SET-Wellbeing Plan | For the Core Health SET-Wellbeing Plan |
|---|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: December 10, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Weihai Dishang Medical Technology Co.,Ltd |
|---|---|
| Address: | Room 406-409,Block C,No.213 Torch Road,Torch High-techIndustrial Development Zone,Weihai,Shandong China |
| Contact person: | Ricky.xia |
| Title: | Manager |
| E-mail: | ricky.xia@dishang.com |
| Tel: | +86- 18663126766 |
2. Device Identification
| 510(K) number: | K210355 |
|---|---|
| Trade/Device Name: | Surgical Gown, Model: surgical gown-hp-3 |
| Common name: | Gown, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FYA |
3. Predicate Device
| 510(K) number: | K202706 |
|---|---|
| Device Name: | Surgical Gown |
| Manufacturer: | B.J.ZH.F.Panther Medical Equipment CO., LTD. |
| Common name: | Gown, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FYA |
{4}------------------------------------------------
4. Device Description
The proposed devices have a SMS design that provides a PB70:2012 level 3 Liquid Barrier Performance Barrier.
The proposed devices are single use, disposable medical devices and can be provided in nonsterile. These surgical gowns are available in six sizes, including S, M, L, XL, XXL and XXXL.
5. Indication for use
The 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 Surgical Gown meets the requirements for Level 3 classification.
The Surgical Gown is single use, disposable medical device provided non-sterile. The Surgical Gown is to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135 prior to marketing to the end user.
{5}------------------------------------------------
6. Compared to Predicate Device
Compared to the predicate device, the subject device has the same intended use, similar product design, same performance effectiveness, performance safety as the predicate device, the comparison is listed in below table:
| Comparisons | Proposed Devicesurgical gown-hp-3K210355 | Predicate DeviceK202706 | remark |
|---|---|---|---|
| Name | Surgical Gown | Surgical Gown (Non-sterile) | / |
| Model | surgical gown-hp-3 | / | / |
| Product code | FYA | FYA | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication foruse | Surgical gowns are intendedto be worn by operating roompersonnel during surgicalprocedure to protect both thesurgical patient and theoperating room personnel fromtransfer of microorganisms,body fluids, and particulatematerial.Per ANSI/AAMI PB70:2012Liquid barrier performanceand classification of protectiveapparel and drapes intended foruse in health care facilities, thesurgical gowns met therequirements for Level 3classification.The Surgical Gown is singleuse, disposable medical deviceprovided non-sterile. TheSurgical Gown is to be sold tore-packager/re-labelerestablishments for ethyleneoxide (EtO) sterilizationaccording to ISO 11135 prior tomarketing to the end user. | Surgical gowns are intendedto be worn by operating roompersonnel during surgicalprocedure to protect both thesurgical patient and theoperating room personnelfrom transfer ofmicroorganisms, body fluids,and particulatematerial.Per ANSI/AAMI PB70:2012Liquid barrier performanceand classification ofprotective apparel anddrapes intended for use inhealth care facilities, thesurgical gowns met therequirements for Level 3classification. | Same |
| Level | 3 | 3 | Same |
| Style | Non-reinforced | Non-reinforced | Same |
| Use | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Weight persquare(g) | 45 g/m² | 55 g/m² | Similar,see note 1 |
| Size | S, M, L, XL, XXL, XXXL | S, M, L, XL, XXL, XXXL | Same |
| Material | SMS polypropylenenonwoven | SMS polypropylenenonwoven + Polyester | Similar,see note 1 |
{6}------------------------------------------------
| Performance | |||||
|---|---|---|---|---|---|
| Test item | Test standard | surgical gown-hp-3 | Predicate Device K202706 | Remark | |
| Water Resistance | Impact penetration | AATCC TM42-2017e | ≤1.0g | ≤1.0g | SameMeet standard requirement |
| Hydrostatic resistance | AATCC 127 - 2017 (2018) | ≥50cm | ≥50cm | SameMeet standard requirement | |
| Tensile Strength | ASTM D5034-09(2017), | ≥30N(7 lbf) | > 20N | Meet standard requirementSee note 2 | |
| Tearing Strength | ASTM D5733-1999 | ≥10N(2.3 lbf) | > 20N | Meet standard requirementSee note 2 | |
| Seam Strength | ASTM D1683/D1683M-2011 | ≥30N(7 lbf) | / | Meet standard requirementSee note 2 | |
| Flammability | 16 CFR Part 1610 | Class 1 | Class 1 | Same |
| Biocompatibility | ||||
|---|---|---|---|---|
| Test item | Teststandard | surgical gown-hp-3 | Predicate DeviceK202706 | Remark |
| Cytotoxicity | ISO 10993-5:2009 | No Cytotoxicity | No Cytotoxicity | Same |
| Skin sensitization | ISO 10993-10:2010 | No Irritation | No Irritation | Same |
| Skin irritation | ISO 10993-10:2010 | No Sensitization | No Sensitization | Same |
| Sterile | / | non-sterile | Sterile/non-sterile | See Note 3 |
Note 1: There is a little difference in material. We had evaluated performance and biocompatibility in according to ANSI AAMI PB70:2012, ASTM F2407-20, ISO 10993-5 and ISO 10993-10, and the result shows no new risk arise.
{7}------------------------------------------------
Note 2: Because of the update of version of ASTM F2407, in new version of the standard, the
test items, tensile strength, tearing strength and seam strength are changed from optional to mandatory, and specify requirement of each test item. The subject devices meet the requirement of new version standard.
Note 3: The subject device is non-sterile surgical gown that are required processing during their use-life.
7. Performance Data Clinical test:
Clinical testing is not required.
Non-clinical data
Performance:
-
ANSI AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
-
ASTM F2407-20 Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
| Test item | Test standard | Criteria | surgical gown-hp-3 | |
|---|---|---|---|---|
| WaterResistance | Impact penetration | AATCC TM42-2017e | ≤1.0g | Pass |
| Hydrostaticresistance | AATCC 127 -2017 (2018) | ≥50m | Pass,Meet level 3requirment | |
| Tensile Strength | ASTM D5034-09(2017), | ≥30N(7 lbf) | Pass | |
| Tearing Strength | ASTM D5733-1999 | ≥10N(2.3 lbf) | Pass | |
| Seam Strength | ASTM D1683/D1683M-2011 | ≥30N(7 lbf) | Pass | |
| Flammability | 16 CFR Part 1610 | Class1 | Pass |
{8}------------------------------------------------
Biocompatibility:
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro 1.
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation 2.
and skin sensitization.
| Test item | Test Standard | Criteria | Results |
|---|---|---|---|
| In Vitro Cytotoxicity | ISO 10993-5: 2009 | Under conditions of the study, thetest article must not show potentialtoxicity. | Pass -Under thecondition ofthe test, thetest article wasfound to benon-toxic |
| Skin Sensitization | ISO 10993-10: 2010 | Under the conditions of the study,the test article must be found tobe non-sensitizing. | Pass - Underthe conditionof the test, thetest article wasfound to benon-sensitizing |
| Skin Irritation test | ISO 10993-10: 2010 | Under the conditions of the test,the test article must be found tobe non- irritating | Pass - Underthe conditionsof the test, thetest article wasfound to benon- irritating |
9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210355, the Surgical Gown, model: surgical gown-hp-3, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202706.
§ 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.