(118 days)
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. This is a single use, disposable device, provided sterile.
The proposed device Disposable Surgical Gowns have body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The Disposable Surgical Gowns are blue color, sterilized by ethylene oxide gas, single use and disposable medical device. The proposed device is available in S (115×140cm), M (120×150cm), L (130×160cm), XL (140×170cm), XXL (150×175cm), and XXXL (170×180cm).
This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
This document is a 510(k) Premarket Notification from the FDA for Disposable Surgical Gowns. It details the device, its intended use, comparison to a predicate device, and results of non-clinical tests.
Here's the breakdown of the acceptance criteria and study information, based on your request, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Seam strength (ASTM D1683M-17) | ASTM D1683M-17 | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (77.54 N) - Average result from 10 samples |
| Breaking strength (ASTM D5034-09) | ASTM D5034-09 (2017) | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 156.87N, CD: 125.20N) - Average result from 10 samples |
| Tear strength (ASTM D5587-15) | ASTM D5587: 2015(2019) | ≥10N | PASS (MD: 66.34N, CD: 38.44N) - Average result from 10 samples |
| Lint and other generation in the dry state (ISO 9073-10:2003(E)) | ISO 9073-10: 2003 | Log10(particle count) < 4 | PASS (2.6) - Average result from 10 samples |
| Flammability (CPSC 16 CFR Part 1610-2008) | CPSC 16 CFR Part 1610-2008 | Class I | PASS (Class I) |
| Water Penetration Resistance (AATCC 42-2013) | AATCC 42: 2013 | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 | PASS (≤1.0g) |
| Static hydrostatic resistance (AATCC 127-2014) | AATCC 127: 2014 | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≥50 cm) |
| EO and ECH sterilization residual (ISO 10993-7:2008) | ISO 10993-7:2008 | EO ≤ 4mg/d, ECH ≤ 9mg/d | PASS (EO ≤ 4mg/d, ECH ≤ 9mg/d) |
| Cytotoxicity (ISO 10993-5) | Not explicitly stated as a separate "Test Standard" column, but referenced ISO | Non-Cytotoxic | PASS (Under the conditions of the study, the device is non-cytotoxic) |
| Irritation (ISO 10993-10) | Not explicitly stated as a separate "Test Standard" column, but referenced ISO | Non-Irritating | PASS (Under the conditions of the study, the device is non-irritating) |
| Sensitization (ISO 10993-10) | Not explicitly stated as a separate "Test Standard" column, but referenced ISO | Non-Sensitizing | PASS (Under the conditions of the study, the device is non-sensitizing) |
2. Sample Size Used for the Test Set and Data Provenance
For the performance tests (Seam strength, Breaking strength, Tear strength, Lint generation), the reported sample size is 10 samples for which an average result is provided for each.
For Water Penetration Resistance, Static hydrostatic resistance, EO/ECH residuals, and Flammability, a specific sample size isn't explicitly stated but the results are indicated as "PASS."
For Biocompatibility (Cytotoxicity, Irritation, Sensitization), the sample size is not explicitly mentioned, but the statements refer to "the conditions of the study" and "the device extract."
The data provenance is from Xiamen Probtain Medical Technology Co., Ltd. in Xiamen, Fujian, China. The studies are non-clinical tests conducted to verify that the proposed device met design specifications. The document does not specify whether the tests were retrospective or prospective, but as they are laboratory performance and material tests for a new device submission, they would typically be conducted prospectively on newly manufactured samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this document. The "device" in question is a surgical gown, and the testing involves physical material properties and biological compatibility, not an AI/diagnostic device that would require human experts to establish ground truth from medical images or clinical data. The acceptance criteria are based on established industry standards (e.g., ASTM, ISO, AAMI, CPSC) and regulatory requirements for medical devices.
4. Adjudication Method for the Test Set
This is not applicable. As this is not an AI/diagnostic device, there is no human interpretation or adjudication of outputs against a ground truth. The results are based on objective measurements from standardized tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
This is not applicable. This document evaluates a physical medical device (surgical gown), not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable. This document evaluates a physical medical device (surgical gown), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by validated test methods and industry standards. For example:
- Physical properties: ASTM standards (D1683M-17, D5034-09, D5587-15) define how to measure properties like seam strength, breaking strength, and tear strength, and define passing criteria.
- Barrier performance: ANSI/AAMI PB70:2012 specifies the liquid barrier performance and classification for protective apparel, which dictates the acceptable levels for water penetration and hydrostatic pressure.
- Flammability: CPSC 16 CFR Part 1610-2008 sets the standard for flammability of clothing textiles.
- Biocompatibility: ISO 10993 series (ISO 10993-5, ISO 10993-10) defines the methods and acceptance criteria for cytotoxicity, irritation, and sensitization.
- Sterilization residuals: ISO 10993-7:2008 sets the acceptable limits for ethylene oxide and ethylene chlorohydrin residuals.
8. The Sample Size for the Training Set
This is not applicable. This document describes performance testing for a physical medical device, not the development or validation of an AI model with a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable. As there is no AI model or training set involved, the concept of establishing ground truth for a training set does not apply here.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
March 7, 2023
Xiamen Probtain Medical Technology Co., Ltd % Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave. Shanghai 200122, China
Re: K223401
Trade/Device Name: Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 1, 2023 Received: March 1, 2023
Dear Jarvis Wu:
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 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
{1}------------------------------------------------
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).
Sincerelv.
Allan Guan -S
For Bifeng Qian, MD, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL)
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. 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)
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}------------------------------------------------
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China
510(K) Summary
K223401
Document prepared date: 2023/03/01
A. Applicant:
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD Address: 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen,Fujian,361100,China Contact Person: Jianli Kang +86-592-7557106 Tel: Fax: +86-592-7199255 Email: kangjianli@probtain.com
Submission Correspondent: Primary contact: Mr. Jarvis Wu 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 Gowns (S,M,L,XL,XXL,XXXL) Common Name: Surgical Gown Model: S,M,L,XL,XXL,XXXL
Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FY A Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K212591 Disposable Surgical Gown Suzhou JaneE Medical Technology Co., Ltd.
{4}------------------------------------------------
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD
4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China
D. Intended use of the device/ 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. This is a single use, disposable device, provided sterile.
E. Device Description:
The proposed device Disposable Surgical Gowns have body, sleeve and belt are made of SMMS nonwoven material, and cuff is made of cotton. The Disposable Surgical Gowns are blue color, sterilized by ethylene oxide gas, single use and disposable medical device. The proposed device is available in S (115×140cm), M (120×150cm), L (130×160cm), XL (140×170cm), XXL (150×175cm), and XXXL (170×180cm).
This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012.
| Device | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Manufacturer | Suzhou JaneE MedicalTechnology Co., Ltd. | XIAMEN PROBTAINMEDICAL TECHNOLOGYCO., LTD | |
| 510K number | K212591 | K223401 | |
| Product Name | Disposable Surgical Gown | Disposable Surgical Gowns | Same |
| Product Code | FYA | FYA | Same |
| Classification | Class II Device, FYA (21CFR878.4040) | Class II Device, FYA(21 CFR878.4040) | Same |
| Intend use | The Disposable SurgicalGowns are intended to beworn by operating roompersonnel during surgicalprocedures to protect thesurgical patient and operatingroom personnel from thetransfer of microorganisms,body fluids and particulatematter. This is a single use,disposable device, providedsterile. | The Disposable Surgical Gownsare intended to be worn byoperating room personnelduring surgical procedures toprotect the surgical patient andoperating room personnel fromthe transfer of microorganisms,body fluids and particulatematter. This is a single use,disposable device, providedsterile. | Same |
| MaterialComposition | Polyolefin (Polypropylene)SMS nonwoven | Sleeve/body/belt (SMMS non-woven)Cuff (Cotton) | Similar |
| Sterility | Sterile | Sterile | Same |
| Sterilization | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
| Method | |||
| SterilizationResiduals | EO ≤ 4mg/dayECH ≤ 9mg/day | EO ≤ 4mg/dayECH ≤ 9mg/day | Same |
| Color | Blue | Blue | Same |
| Size | M,L,XL,TL | S、M、L、XL、XXL、XXXL | Similar. Noeffect onsafety orefficacy |
| Weight persquare(g) | Critical Area: 87.8g/m²Non-Critical Area: 45.12g/m² | 44g/m² | Similar. Noeffect onsafety or |
| efficacy. | |||
| Tensile(Breakingstrength)D5034-09 | MD: 16.18 lbs (72N)CD: 13.26 lbs (59N) | MD: 156.87NCD: 125.20N | Similar. Noeffect onsafety orefficacy.Both passedperformancetests. |
| TearingStrengthASTMD5587-15 | MD:22.25 lbs (99 N)CD:18.20 lbs (81N) | MD: 66.34NCD: 38.44N | Similar. Noeffect onsafety orefficacy.Both passedperformancetests. |
| Seam StrengthASTMD16383M-17 | Sleeve Seam:68.3NSide Seam:69.7NBelt Seam:71N | 77.54N | Similar. Noeffect onsafety orefficacy.Both passedperformancetests. |
| HydrostaticPressure(cm)AATCC-127 | >50 cm | >50 cm | Same |
| Water Impact(g) AATCC-42 | ≤1.0 g | ≤1.0 g | Same |
| Resistance toblood and liquidpenetration | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same |
| Biocompatibility | Under the conditions of thestudy, the device extract wasnot cytotoxic. | Under the conditions of thestudy, the device extract wasnot cytotoxic | Same |
F. Comparison with predicate device
{5}------------------------------------------------
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China
{6}------------------------------------------------
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fuijan,361100, China
| Under the conditions of thestudy, the non-polar and polardevice extracts were not foundto be an irritant. Underconditions of the study, thenon-polar and polar deviceextracts were not found to be asensitizer. | Under the conditions of thestudy, the non-polar and polardevice extracts were not foundto be an irritant. Underconditions of the study, thenon-polar and polar deviceextracts were not found to be asensitizer. |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Different analysis:
The proposed surgical gowns are similar to the predicate device, in terms of general intended use, performance testing, material composition, and configuration. The tearing strength, breaking strength and seam strength are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ASTM D1683/ D1683M-17(2018) respectively, and met the requirements of the standard.
Under the conditions of each study, the proposed surgical gown is non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.
G. Summary of Non-Clinical Test 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 Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A ISO 10993-7:2008(R) 2012 Biological evaluation of medical devices -Part 7: Ethylene oxide sterilization residuals
- CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles; A
-
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of
- Textile Fabrics (Grab Test);F
ASTM D5587-15. Standard Test Method for Tearing Strength of Fabrics by Trapezoid > Procedure;
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective > Apparel and Drapes Intended For Use In Health Care Facilities.
A 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 A Woven Fabrics
| Test Item | Test standard | Acceptance Criteria | Result |
|---|---|---|---|
| Seam strengthASTM D1683M-17Standard Test Methodfor Failure in Sewn | The test was performedIn accordance withASTM D1683M-17Standard. Test Method | ≥30N(7lbf)per standardF2407-20 for level 3 | PASS77.54 N |
| Seams of Woven Fabrics. | for Seam Strength of Textile Fabrics (Grab Test) to evaluate Failure in Sewn Seams of the test sample. | (Average result from 10 samples) | |
| Breaking strengthASTM D5034-09(2017) Standard TestMethod for BreakingStrength andElongation of TextileFabrics (Grab Test) | The test was performedIn accordance withD5034-09 (2017) .Standard. Test Methodfor Breaking Strengthand Elongation of TextileFabrics (Grab Test) toevaluate thebreaking strength of thetest sample. | ≥30N(7lbf)per standardF2407-20 for level 3 | PASSMD: 156.87NCD: 125.20N(Average result from 10 samples) |
| Tear strength(N)ASTM D5587-15,Standard Test Methodfor Tearing Strength ofFabrics by TrapezoidProcedure | The test was performedin accordance withASTM D5587:2015(2019) StandardTest Method for TearingStrength of Fabrics byTrapezoid Procedure toevaluatethe tearing strength of thetest sample. | ≥10N | PASSMD: 66.34NCD: 38.44N(Average result from 10 samples) |
| Lint and othergeneration in thedry stateISO 9073- 10:2003(E) | The test was performedin accordance with ISO9073-10: 2003 Textiles-Test Methods forNonwovens-Part 10: Lintand Other ParticlesGeneration in the DryState to evaluate thelinting of the testsample. | Log10(particle count)< 4 | PASS2.6(Average result from 10 samples) |
| FlammabilityCPSC 16 CFR Part1610-2008, Standardfor the Flammability ofclothing textiles | The test was performedin accordance with 16CFR Part 1610Standard for theFlammability of ClothingTextiles to evaluate theflammability of the testsample. | Class I | PASSClass I |
| Water PenetrationResistanceAATCC 42-2013,Impact Penetration Test | The test was performedin accordance withAATCC 42: 2013Water Resistance: ImpactPenetration Test toevaluate the water impact | ≤1.0g AQL: 4%Level 3 per standardANSI/AAMIPB70:2012 for level 3 | PASS≤1.0g |
| Static hydrostaticresistanceAATCC 127-2014,Water Resistance:Hydrostatic PressureTest; | The test was performedin accordance withAATCC 127: 2014Water Resistance:Hydrostatic Pressure Testto determine thehydrostatic pressure ofthe test sample. | ≥50 cmH2O perstandard ANSI/AAMIPB70:2012 for level 3 | PASS≥50 cm |
| EO and ECHsterilizationresidual ISO10993-7:2008Ethylene oxidesterilization residuals | The test was performedin accordance with ISO10993-7:2008Ethylene oxidesterilization residuals todetermine the EO andECH residuals of the testsample. | $EO ≤ 4mg/d$$ECH ≤ 9mg/d$ | PASS$EO ≤ 4mg/d$$ECH ≤ 9mg/d$ |
Table 2 nerformance test
{7}------------------------------------------------
XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD 4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China
{8}------------------------------------------------
Table3 Biocompatibility endpoints assessment
| Test Item | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|
| Cytotoxicity ISO10993-5 | Under the conditions of the study, the device isnon-cytotoxic. | Non-Cytotoxic | PASS |
| IrritationISO 10993-10 | Under the conditions of the study, the device isnon-irritating. | Non-Irritating | PASS |
| SensitizationISO 10993-10 | Under the conditions of the study, the device isnon-sensitizing | Non-Sensitizing | PASS |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL), is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Disposable Surgical Gowns cleared under K212591.
§ 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.