(353 days)
Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare persomel to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter.
The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/A AMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).
The Donagamex protective gowns are sold non-sterile, single use. They are not intended for use in the operating room.
The Donagamex Blue Performance Protective Gown is a Class II medical device under the FDA product code QPC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Donagamex Blue Performance Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993. The Donagamex Blue Performance Protective Gowns are non-woven, blue gowns, available in various sizes and have no areas of reinforcement. They are made from a layer of polyethylene laminated over spun-bonded polypropylene and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a protective gown. The Donagamex Blue Performance Protective Gown is a single use, disposable medical device that will be sold non-sterile.
The provided text is related to the 510(k) premarket notification for a medical device: "Donagamex Blue Performance Protective Gown" (K203821). This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" largely refers to the non-clinical performance tests conducted to ensure the protective gown meets specific standards for barrier protection, material strength, flammability, and biocompatibility.
Here's a breakdown of the information as it can be extracted from the document, tailored to the requested structure:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Reference) | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AATCC 42:2017 Water Resistance: Impact Penetration | Determine resistance of gown to the penetration of water by impact | Level 3: ≤ 1.0 gm (This correlates to AAMI PB70 Level 3 barrier requirements for liquid penetration) | Pass |
| AATCC 127:2018 Water Resistance: Hydrostatic Pressure | Determine resistance of gown to the penetration of water under hydrostatic pressure | Level 3: ≥ 50 cm (This correlates to AAMI PB70 Level 3 barrier requirements for hydrostatic resistance) | Pass |
| ASTM - D5034:2017 Breaking Strength and Elongation of Textile Fabrics (Grab Test) | Determine the breaking strength of gown | More or equals to 7 lbs | Pass |
| ASTM - D5587:2019 Tearing Strength of Fabrics by Trapezoid Procedure | Determine the tearing strength of gown | More or equals to 2.3 lbs | Pass |
| ASTM - D751:2019 Coated Fabrics (Seam Strength) | Determine if any failure occurs in gown seams | More or equals to 7 lbs | Pass |
| 16 CFR Part 1610 Flammability Test Method Standard for Flammability of Clothing Textiles | To test the clothing textile flammability | Class I Normal Flammability Result (Meets Class I Flammability per CPSC, Part 1610) | Pass |
| ISO 10993-5:2009 In vitro Cytotoxicity | To determine if device extract is cytotoxic | The device must be non-cytotoxic | Non-cytotoxic |
| ISO 10993-10:2010 Primary Skin Irritation | To determine if device is a skin irritant | The device must be a non-irritant | Not an irritant |
| ISO 10993-10:2010 Dermal Sensitization | To determine if device is a dermal sensitizer | The device must be a non-sensitizer | Not a sensitizer |
Note: ASTM - D3776:2020 (Mass Per Unit Area) and ISO 9073-10 (Lint & other Particles Generation) were listed with purpose but "N/A" for acceptance criteria and results in the provided table, suggesting they were likely characterization tests rather than tests against specific acceptance thresholds for clearance in this context.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Barrier Performance: For the AAMI PB70:2012 liquid barrier testing, the document states: "Testing was performed using 3 nonconsecutive lots and 32 samples per lot in each critical zone area." This means a total of 96 samples (3 lots * 32 samples/lot) were tested per critical zone (chest, back, and sleeve seam).
- Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the manufacturer is "Dong Nai Garment Corporation" located in Vietnam. The tests are referenced against international and US standards (AATCC, ASTM, ISO, CFR). The timeframe implies these tests were conducted retrospectively for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable for this type of device and study. This device is a protective gown, and the performance evaluation relies on standardized physical, chemical, and biological testing methods rather than expert interpretation of images or clinical outcomes. The "ground truth" is established by the test methods themselves and their defined pass/fail criteria.
4. Adjudication Method for the Test Set
- Not applicable. As the device is characterized by objective physical and material properties assessed via standardized tests, there is no human interpretation or adjudication process involved in the test results.
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 section is relevant for AI/ML-driven diagnostic devices that assist human readers (e.g., radiologists). The "Donagamex Blue Performance Protective Gown" is a Class II surgical apparel, not an AI/ML diagnostic device, and therefore, no MRMC study was conducted or is relevant. The study performed is a non-clinical performance study against established material and barrier standards.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As explained above, this device is not an algorithm or AI system. Its performance is entirely standalone in terms of its physical properties. The tests performed are "standalone" in the sense that they evaluate the device's inherent properties without human interaction beyond conducting the test protocol.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is based on objective, standardized test methods and their defined performance criteria (e.g., AAMI PB70:2012 for liquid barrier, ASTM standards for material strength, CPSC 1610 for flammability, and ISO 10993 for biocompatibility). These are physical and biological measurements against pre-defined thresholds.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this device does not involve machine learning or AI models that require data for training. The product is manufactured and then tested to ensure it meets performance specifications.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no corresponding ground truth establishment process for it. The "ground truth" for demonstrating substantial equivalence and device performance is established through adherence to recognized consensus standards for material testing and barrier properties.
{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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 10, 2022
Dong Nai Garment Corporation (Donagamex) % Bari Steinberg Official Correspondent for Dong Nai Garment Corporation (Donagamex) mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K203821
Trade/Device Name: Donagamex Blue Performance Protective Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: OPC
Dear Bari Steinberg:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 17, 2021. Specifically, FDA is updating this SE Letter to inlude the finalized trade name of the device as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Clarance Murray, OHT4: Office of Surgical and Infection Control Devices, 301-796-0870, Clarence.Murray@fda.hhs.gov.
Sincerely,
Liqun Zhao -S
For Clarence W. Murray, III, 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
{1}------------------------------------------------
Image /page/1/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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2021
Dong Nai Garment Corporation (Donagamex) Bari Steinberg Official Correspondent for Dong Nai Garment Corporation (Donagamex) mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021
Re: K203821
Trade/Device Name: Donagamex Blue Performance Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OPC Dated: August 29, 2021 Received: September 7, 2021
Dear Bari Steinberg:
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
{2}------------------------------------------------
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 medical devices and radiation-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,
Ligun Zhao -S
For Clarence W. Murray, III, 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
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K203821
Device Name
Donagamex Blue Performance Protective Gown
Indications for Use (Describe)
Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare persomel to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter.
The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/A AMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).
The Donagamex protective gowns are sold non-sterile, single use. They are not intended for use in the operating room.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 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."
{4}------------------------------------------------
510(K) SUMMARY
The assigned 510(k) number is: K203821
Date Summary Prepared: December 17, 2021
1. Submitter's Identification:
Dong Nai Garment Corporation
Road 2, Bien Hoa Industrial Zone 1 An Binh Ward, Bien Hoa City Dong Nai Province, Vietnam Tel.: +84 0253 836147 Fax: +84 0253 836151
Official Correspondent: Bari Steinberg, mdi Consultants Inc. E-mail: bari@mdiconsultants.com
2. Device Name: Donagamex Blue Performance Protective Gown
3. Regulatory Information:
Regulation Number: 21 CFR 878.4040 Device Class: Class II Regulation Name: Surgical Apparel Product Code: QPC Common Name: Gown, Non-Sterile, Non-Isolation
4. Predicate Device Information:
510K Number: K160337 Device Name: ValueCare Open Back Protective Gown
5. Intended Use:
Donagamex protective gowns are non-sterile, single use surgical apparel intended to be worn by healthcare personnel to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The Donagamex protective gowns meet the requirements of AAMI Level 3 barrier protection for a protective gown per ANSI/AAMI PB70: 2012 Liquid Barrier Performance and Classification of protective apparel and drapes intended for use in healthcare facilities (AAMI PB70).
The Donagamex protective gowns are sold non-sterile, single use. They are not intended for use in the operating room.
{5}------------------------------------------------
6. Device Description:
The Donagamex Blue Performance Protective Gown is a Class II medical device under the FDA product code QPC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Donagamex Blue Performance Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993. The Donagamex Blue Performance Protective Gowns are non-woven, blue gowns, available in various sizes and have no areas of reinforcement. They are made from a layer of polyethylene laminated over spun-bonded polypropylene and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a protective gown. The Donagamex Blue Performance Protective Gown is a single use, disposable medical device that will be sold non-sterile.
7. Device and Predicate Device Technical Characteristics:
| COMPARISONCRITERIA | SUBJECT DEVICE(K203821) | PREDICATE DEVICE(K160337) | COMPARISONRESULT |
|---|---|---|---|
| Device Name | Donagamex BluePerformance ProtectiveGown(AAMI Barrier Level 3) | ValueCare Open BackProtective Gowns(AAMI Barrier Level 3) | N/A |
| Manufacturer | Dong Nai GarmentCorporation (Donagamex) | ValueCare | N/A |
| Classification | Surgical Apparel21 CFR Part 878.4040Product Code: QPCClass II | Surgical Apparel21 CFR Part 878.4040Product Code: QPCClass II | Same |
| Indications for Use | Donagamex BluePerformance ProtectiveGowns are non-sterile,single use surgical apparelintended to be worn byhealthcare professionals tohelp protect both thepatient and the health carepersonnel from thetransfer of microorganisms,body fluids, and particulatematter.The Donagamex Protectivegown meets therequirements of AAMILevel 3 barrier protectionfor a protective gown per | These gowns are intendedto protect health carepatients and health carepersonnel from the transferof micro- organisms, bodyfluids and particulatematerial. The back of thegown is open and non-protective. They are notintended for use in theoperating room. | Similar |
| ANSI/AAMI PB70: 2012Liquid Barrier Performanceand Classification ofprotective apparel anddrapes intended for use inhealthcare facilities (AAMIPB70).The Donagamex protectivegowns are sold non-sterile,single use. They are notintended for use in theoperating room. | |||
| Sterile or Non-Sterile | Non-Sterile | Non-sterile | Same |
| Reusable orDisposable (SingleUse) | Single use | Single use | Same |
| Design | Elastic at the cuff forkeeping the sleeves inplace on the wearer,belt tie | Design includes open back,thumb loops, backperforation for easy removaland waist tie | Similar |
| MaterialComposition | Nonwoven polypropylenespunbond fabricwith polyethylene laminatefilm (SF) | Made from extruded plasticfilm | Similar |
| Size | Medium to XX-Large | Not reported in 510kSummary | N/A |
| Color | Blue | Blue | Same |
| SterilizationMethod (ifapplicable) | None, non-sterile gowns | None, non-sterile gowns | Similar |
| Packaging | Bulk for non-sterile gowns | Not reported in 510kSummary | N/A |
| Natural rubberLatex | Not made with naturalrubber latex | Not made with NaturalRubber Latex | Same |
| PERFORMANCE TEST RESULTS : | |||
| AATCC 42 WaterResistance: ImpactPenetration (g) | Meets AAMI PB70 BarrierClassification for Level 3 | Meets AAMI PB70 BarrierClassification for Level 3 incritical zones | Same |
| AATCC 127 WaterResistance:HydrostaticPressure (cm) | Meets AAMI PB70 BarrierClassification for Level 3 | Meets AAMI PB70 BarrierClassification for Level 3 incritical zones | Same |
| Liquid BarrierPerformanceClassification | Device was tested inaccordance with AAMI PB70:2012 and meets AAMILevel 3 barrier protectionrequirements for aprotective gown. Testingwas performed using 3nonconsecutive lots and 32samples per lot in eachcritical zone area. Thecritical zone areas testedwere the chest, back andsleeve seam. | Device meets the barrierprotection requirements ofAAMI Level 3 perANSI/AAMI PB70:2012, buthas an open back which isnon-protective. | Similar |
| ASTM - D3776Standard TestMethods for MassPer Unit Area(Weight) of Fabric | Pass | Not reported in 510kSummary | N/A |
| ASTM - D5034Standard TestMethod forBreaking Strengthand Elongation ofTextile Fabrics(Grab Test) | Pass | Not reported in 510kSummary | N/A |
| ASTM - D5587Standard TestMethod forTearing Strength ofFabrics byTrapezoidProcedure | Pass | Not reported in 510kSummary | N/A |
| ASTM - D751Standard TestMethods forCoated Fabrics(Seam Strength) | Pass | Not reported in 510kSummary | N/A |
| Flammability TestMethod Standardfor Flammability ofClothing Textiles(16 CFR Part 1610) | Meets Class I Flammabilityper CPSC, Part 1610 | Meets Class I Flammabilityper CPSC, Part 1610 | Same |
| Textiles ISO 9073-10Test Method forNonwovens Part10: Lint & other | Pass | Not reported in 510kSummary | N/A |
| ParticlesGeneration in theDry State | |||
| ISO 10993 Part-1BiologicalEvaluation ofMedical Devices.Biocompatibilitytests includedcytotoxicity,sensitization andirritation. | Non-cytotoxic, non-sensitizing, non-irritating | Non-cytotoxic, non-sensitizing, non-irritating | Same |
Table 1: Side by Side Comparison
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
Both gowns are disposable, single use, non-reinforced gowns intended to help protect from the transfer of body fluids and particulate matter in settings other than the operating room. They are similar in color, design and are both offered as non-sterile.
The primary difference is that the ValueCare Open Back Protective Gown provides liquid barrier protection in front of gown only (critical zones), while the Donagamex Blue Performance Protective Gowns provide AAMI Level 3 in front and back of gown.
The above differences in design and AAMI liquid protection level raise no new issues of safety and effectiveness since both gowns are designed, tested, and labeled in compliance with the applicable AAMI PB70: 2012 liquid barrier requirements.
8. Summary of Clinical Testing:
Clinical performance for non-sterile, disposable protective gowns is not applicable for this product. Numerous predicated devices (gowns) exist and have been used extensively for a number of years that are made from the same or similar materials.
9. Summary of Non-Clinical Performance Testing:
The information in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to devices already in commercial distribution. Equivalence is demonstrated through intended use, materials, design test methods including physical, mechanical, liquid barrier and biocompatibility testing. The Donagamex Blue Performance Protective Gown was found to be acceptable for its intended use in each of these applicable industry recognized standards:
AATCC 42:2017 Standard Test Method for Water Resistance: Impact Penetration
AATCC 127:2018 Standard Test Method for Water Resistance: Hydrostatic Pressure
ASTM - D5034:2017 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM - D5587:2019 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
{9}------------------------------------------------
ASTM - D751:2019 Standard Test Methods for Coated Fabrics
ASTM - D3776:2020 Standard Test Methods for Mass Per Unit Area (Weight) of Fabric
16 CFR Part 1610 - Flammability Test Method Standard for Flammability of Clothing Textiles
ISO 9073-10 Textiles - Test Method for Nonwovens Part 10: Lint & other Particles Generation in the Dry State
AMMI /ANSI / ISO 10993-5:2009 – In Vitro Cytotoxicity using Agar Overlay test (USP, ISO)
AAMI / ANSI / ISO 10993-10:2010 – In Vitro Irritation reactivity using Primary Skin Irritation Test
AAMI / ANSI / ISO 10993-10:2010 – In Vitro Sensitization using the Buehler Method Test
Table 2: Non-Clinical Tests
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| AATCC 42:2017Standard Test Methodfor Water Resistance:Impact Penetration | Determine resistance ofgown to thepenetration of water byimpact | Level 3: ≤ 1.0 gm | Pass |
| AATCC 127:2018Standard Test Methodfor Water Resistance:Hydrostatic Pressure | Determine resistance ofgown to thepenetration of waterunder hydrostaticpressure | Level 3: ≥ 50 cm | Pass |
| ASTM - D5034:2017Standard Test Methodfor Breaking Strengthand Elongation ofTextile Fabrics (GrabTest) | Determine the breakingstrength of gown | More or equals to7 lbs | Pass |
| ASTM - D5587:2019Standard Test Methodfor Tearing Strength ofFabrics by TrapezoidProcedure | Determine the tearingstrength of gown | More or equals to2.3 lbs | Pass |
| ASTM - D751:2019Standard Test Methodsfor Coated Fabrics | Determine if any failureoccurs in gown seams | More or equals to7 lbs | Pass |
| ASTM - D3776:2020Standard Test Methodsfor Mass Per Unit Area(Weight) of Fabric | Determine the fabricweight | N/A | N/A |
{10}------------------------------------------------
| Flammability TestMethod Standard forFlammability ofClothing Textiles (16CFR Part 1610) | To test the clothingtextile flammability | Class I NormalFlammability Result | Pass |
|---|---|---|---|
| ISO 9073-10Textiles - Test Methodfor Nonwovens Part 10:Lint & other ParticlesGeneration in the DryState | Characterize the sizeand quantity of the lintgeneration | N/A | N/A |
Table 3: Biocompatibility Tests
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| In vitro CytotoxicityISO 10993-5:2009 | To determine if deviceextract is cytotoxic | The device must be non-cytotoxic | Under the studyconditions non-cytotoxic |
| Primary Skin IrritationISO 10993-10:2010 | To determine if device isa skin irritant | The device must be anon-irritant | Under the studyconditions not anirritant |
| Dermal SensitizationISO 10993-10:2010 | To determine if device isa dermal sensitizer | The device must be anon-sensitizer | Under the studyconditions not asensitizer |
10. Conclusions:
Based on the non-clinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, K160337.
§ 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.