(236 days)
The Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room.
The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective.
These gowns are single use, disposable medical devices provided non-sterile.
Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material These gowns are not intended - for use in the operating room. The gowns are available on Regular and X-Large sizes.
Dukal AAMI Level 4 Open-Back Protective Gowns are made with laminate material (SMS nonwoven material with polyethylene film).
All gowns are blue, with neck removal feature, belt ties, and thumb hook cuff sleeves.
These gowns are single use, disposable devices, that are provided non-sterile.
The provided document is a 510(k) premarket notification for a medical device: Dukal AAMI Level 4 Open-Back Protective Gown. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories related to clinical trials, multi-reader multi-case studies, and AI-specific ground truth are not applicable.
Here's the breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Test Requirements) | Reported Device Performance (Dukal AAMI Level 4 Open-Back Protective Gown) |
|---|---|---|
| Blood-Borne Pathogens penetration | Pass (For AAMI Level 4 Requirements): None Seen for Penetration of Phi-X174 Bacteriophage (ASTM F1671) | Pass |
| Hydrostatic pressure | ≥100 cm H2O (Individual)≥140 cm H2O (Average) (AATCC 127) | >130 cm H2O |
| Basis weight | 50±6 gsm (ASTM D3776) | 50±6 gsm |
| Tensile strength | Machine Direction (MD) ≥ 30 NCross Direction (CD) ≥ 30 N (ASTM D5034) | Machine Direction (MD) ≥ 30 NCross Direction (CD) ≥ 30 N |
| Tear strength | Machine Direction (MD) ≥ 10 NCross Direction (CD) ≥ 10 N (ASTM D5587) | Machine Direction (MD) ≥ 10 NCross Direction (CD) ≥ 10 N |
| Seam Strength | ≥30 N (ASTM D 1683) | ≥30 N |
| Lint generation | Size of particles counted: 3mcg-25mcg (ISO 9073-10) | Size of particles counted: 3mcg-25mcg |
| Flammability | Class I (16 CFR Part 1610) | Class I |
| Biocompatibility (Cytotoxicity) | Under the conditions of the study, the device does not show cytotoxicity potential. (ISO 10993-5) | Under the conditions of the study, the device did not show cytotoxicity potential. |
| Biocompatibility (Irritation) | Under the conditions of the study, the irritation response category of the device is classified as Negligible. (ISO 10993-10) | Under the conditions of the study, the irritation response category of the device was classified as Negligible. |
| Biocompatibility (Sensitization) | Under the conditions of the study, the device shows no significant evidence of causing skin sensitization. (ISO 10993-10) | Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. |
| Liquid Barrier Performance Classification | All areas tested meet Level 4 performance requirements (ASTM F1671), which is the highest standardized level of barrier performance. Meets barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. (For critical zone areas: body or sleeve (same material) and heat sealed seam(s)). | All areas tested meet Level 4 performance requirements (ASTM F1671), which is the highest standardized level of barrier performance. Meets barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Testing was performed in accordance with ASTM F1671 using 3 lots and 32 samples per lot in each critical zone area. The critical zone areas tested were the body or sleeve (same material) and the heat sealed seam(s). |
2. Sample size used for the test set and the data provenance
- Sample Size: For the Liquid Barrier Performance Classification test (ASTM F1671), the testing was performed using 3 lots and 32 samples per lot in each critical zone area (body/sleeve and heat-sealed seams). For other tests, specific sample sizes are not explicitly stated within the provided text, but the results are reported as meeting the requirements.
- Data Provenance: The nature of these tests (material properties) suggests they were conducted in a laboratory setting. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as these terms are not typically applicable to physical product testing of this kind.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are non-clinical, objective material property tests and do not involve expert interpretation or ground truth establishment by medical professionals. The "ground truth" is determined by the standardized test methods and their defined pass/fail criteria.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for dispute resolution or consensus building among human readers, typically in image interpretation or clinical diagnosis. These tests involve objective physical measurements against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools with human readers. The device in question is a protective gown, which is not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is not an algorithm or AI model.
7. The type of ground truth used
For this device, the "ground truth" is the objective, measurable performance against established industry standards (e.g., AAMI Level 4 requirements, ASTM, ISO, AATCC standards). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for a protective gown's material performance. The ground truth is embedded in the standardized test methods and their pass/fail criteria.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows 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.
March 30, 2022
Dukal, LLC Megan Quevedo Quality and Regulatory Affairs Supervisor 2 Fleetwood Court Ronkonkoma, New York 11779
Re: K212464
Trade/Device Name: Dukal AAMI Level 4 Open-Back Protective Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OPC Dated: March 2, 2022 Received: March 2, 2022
Dear Megan Quevedo:
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
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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, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212464
Device Name Dukal AAMI Level 4 Open-Back Protective Gown
Indications for Use (Describe)
The Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room.
The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective.
These gowns are single use, disposable medical devices provided non-sterile.
| 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) |
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510(k) K212464 SUMMARY
510(k) Premarket Notification for Dukal AAMI Level 4 Open-Back Protective Gown
| 1. | Submitter: | Dukal, LLC2 Fleetwood CourtRonkonkoma NY 11779Phone: 631-656-3800Fax: 631-656-3810 |
|---|---|---|
| 2. | FDA Registration Number: | 2435946 |
| 3. | Regulatory Affairs Contact: | Megan QuevedoQuality and Regulatory Affairs Supervisor2 Fleetwood CourtRonkonkoma NY 11779Telephone Number: 631-656-3800 ext. 133Fax Number: 631-656-3810 |
| 4. | Date Summary Prepared: | March 29, 2022 |
| 5. | Name of Device: | Dukal AAMI Level 4 Open-Back Protective Gown |
| 6. | Trade Name: | Dukal AAMI Level 4 Open-Back Protective Gown |
| 7. | Common/Classification Name: | Gown, Non-Sterile, Non-Isolation, Intended to ProvideModerate or High Barrier Protection |
| 8. | Regulation Number: | 21 CFR §878.4040 |
| 9. | Device Class: | Class II |
| 10. | Regulation Name: | Surgical Apparel |
| 11. | Product Code: | QPC |
| 12. Predicate Device: | Cardinal Health Poly-Coated Open-Back ProtectiveGowns (level 4)• 510k #K182830, cleared on 4/26/2019 | |
| 13. Device Description: | Dukal AAMI Level 4 Open-Back Protective Gowns areintended to protect health care personnel and patientsfrom the transfer of microorganisms, body fluids, andparticulate material These gowns are not intended - for | |
| use in the operating room. The gowns are available onRegular and X-Large sizes. | ||
| Dukal AAMI Level 4 Open-Back Protective Gowns aremade with laminate material (SMS nonwoven materialwith polyethylene film). | ||
| All gowns are blue, with neck removal feature, belt ties,and thumb hook cuff sleeves. | ||
| These gowns are single use, disposable devices, that areprovided non-sterile. | ||
| 14. Packaging: | 10 gowns/bag, 5 bags/case | |
| 15. Indications for Use: | The Dukal AAMI Level 4 Open-Back Protective Gown areintended to protect health care personnel and patientsfrom the transfer of microorganisms, body fluids, andparticulate material. These gowns are not intended foruse in the operating room. | |
| The Dukal AAMI Level 4 Open-Back Protective Gownmeets the barrier protection requirements of AAMILevel 4 per ANSI/AAMI PB70, Liquid BarrierPerformance and Classification of Protective Appareland Drapes Intended for Use in Health Care Facilities,but has an open back which is non-protective. | ||
| These gowns are single, use, disposable medical devices |
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16. Comparison of Technological Characteristics with the Predicate Device:
| Element ofComparison | Predicate Device CardinalHealth (K182830) Poly-CoatedOpen-Back Gown | Subject Device DukalOpen-Back ProtectiveGown (K212464) | Comparison |
|---|---|---|---|
| Indications forUse | The Cardinal Health Poly-Coated Open-Back ProtectiveGown is intended to protecthealth care personnel andpatients from the transfer ofmicroorganisms, bodyfluids and particulate material.Not intended for use in theoperating room. | The Dukal AAMI Level 4Open-Back ProtectiveGowns are intended toprotect health carepersonnel and patientsfrom the transfer ofmicroorganisms, bodyfluids, and particulatematerial. These gowns are | Same |
| Cardinal Health Poly-Coated | |||
| Open-Back Protective | not intended for use in | ||
| Gown meets the barrier | the operating room. | ||
| protection requirements of | |||
| AAMI Level 4 per ANSI/AAMI | The Dukal AAMI Level 4 | ||
| PB70:2012, Liquid Barrier | Open-Back Protective | ||
| Performance and Classification | Gown meets the barrier | ||
| of Protective Apparel | protection requirements | ||
| and Drapes Intended for Use in | of AAMI Level 4 per | ||
| Health Care Facilities, but has | ANSI/AAMI PB70, Liquid | ||
| an open back which | Barrier Performance and | ||
| is non-protective. The Cardinal | Classification of Protective | ||
| Health™ Poly-Coated Open- | Apparel and Drapes | ||
| Back Protective Gown | Intended for Use in Health | ||
| is a single use, disposable | Care Facilities, but has an | ||
| medical device provided non- | open back which is non- | ||
| sterile | protective. | ||
| These gowns are single, | |||
| use, disposable medical | |||
| devices provided non- | |||
| sterile. | |||
| BarrierProtectionLevel | AAMI Level 4 per ANSI/AAMIPB70:2012,Liquid Barrier Performance andClassification of ProtectiveApparel andDrapes Intended for Use inHealth Care Facilities, but hasan open back which isnonprotective. | AAMI Level 4 perANSI/AAMI PB70:2012,Liquid BarrierPerformance andClassification of ProtectiveApparel andDrapes Intended for Use inHealth Care Facilities, buthas an open back which isnonprotective. | Same |
| Regulation,Classification,Product Code | Regulation Number: 21 CFR§878.4040Device Class: Class IIRegulation Name: SurgicalApparelProduct Code: QPC | Regulation Number: 21CFR §878.4040Device Class: Class IIRegulation Name: SurgicalApparelProduct Code: QPC | Same |
| MaterialComposition | Laminate (spunbondpolypropylene coatedwith polyethylene) | Laminate (Spunbond +Meltblown + Spunbond(SMS) with polyethylenefilm) | Similar |
| Product Colorand Sizes | BlueUniversal and XX-Large | BlueRegular and X-Large | Similar |
| Design Features | Thumbhook cuff formed intosleeve or knit cuff sewn ontosleeve for keeping the sleevesin place on the wearer | Thumbhook cuff formedinto sleeve for keeping thesleeves in place on thewearer | Similar |
| Belt Ties integrated into bodyNeck removal feature | Belt Ties integrated intobodyNeck removal feature | ||
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Biocompatibility | Under the conditions of eachstudy, the Cardinal HealthTMPoly-Coated Open- BackProtective Gown is non-cytotoxic (ISO 10993-5), is non-irritating (ISO 10993-10), and isnon-sensitizing (ISO 10993-10). | Under the conditions ofeach study, the DukalAAMI Level 4 Open-BackProtective Gown is non-cytotoxic (ISO 10993-5), isnon-irritating (ISO 10993-10), is non-sensitizing (ISO10993-10). | Same |
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Comparison Summary of Non-Clinical Testing Results
| Test | Test Results of Subject DeviceDukal AAMI Level 4 Open-BackProtective Gown (meetsANSI/AAMI PB70:2012 Level 4requirements)Note: Below results are for Sleeveand Body material | Test Results of Predicate DeviceCardinal Health (K182830) Poly-Coated Open-Back Gown (meetsANSI/AAMI PB70:2012 Level 4requirements)Finished Good Test Results:Mean (min/max)Note: Below results are forSleeve and Body material | Comparison |
|---|---|---|---|
| Basis WeightASTMD3776/D3776M-20 | 50±6 gsm | 43.3 (39.9 / 46.1) gsm(according to previous revisionASTM D3776/D3776M-17) | Similar |
| Tensile StrengthASTM D5034-21 | Machine Direction (MD)≥ 30 NCross Direction (CD)≥ 30 N | 14.2 (12.6 / 16.1) lb (CD)(according to previous revisionASTM D5034-17) | Similar |
| Tear StrengthASTM D5587-15(2019) | Machine Direction (MD)≥ 10 NCross Direction (CD)≥ 10 N | 6.0 (4.4 / 7.5) lb (MD) | Similar |
| Seam Strength(ASTM D 1683) | ≥30N | ≥30N | Same |
| FlammabilityCPSC, Part 1610 | Class 1 | Class 1 | Same |
| Lint Generation(ISO 9073-10) | Size of particles counted: 3mcg-25mcg | Size of particles counted: 3mcg-25mcg | Same |
| HydrostaticHeadAATCC 127:2018 | >130 cmH20 | >130 (130 / >130) cmH20>51 (51 / >51) inH20(According to previous revisionAATCC 127:2017) | Same |
| Viral barrier(resistance tobacteriophagePhi-X174)ASTM F1671-13 | Pass (For AAMI Level 4Requirements): None Seen forPenetration of Phi-X174Bacteriophage | Pass (For AAMI Level 4Requirements): None Seen forPenetration of Phi-X174Bacteriophage | Same |
| Liquid BarrierPerformanceClassificationProperties | All areas tested meet Level 4performance requirements(ASTM F1671), which is thehighest standardized level ofbarrier performance | All areas tested meet Level 4performance requirements(ASTMF1671), which is the higheststandardized level of barrierperformance | Same |
| The Dukal AAMI Level 4 Open-Back Protective Gown meets thebarrier protection requirements ofAAMI Level 4 per ANSI/AAMIPB70:2012, Liquid BarrierPerformance and Classification ofProtective Apparel and DrapesIntended for Use in Health CareFacilities, but has an open backwhich is non-protective. Testingwas performed in accordance withASTM F1671 using 3 lots and 32samples per lot in each criticalzone area. The critical zone areastested were the body or sleeve(same material) and the heatsealed seam(s). | The Cardinal Health™ Poly-CoatedOpen-Back Protective Gownmeets the barrier protectionrequirements of AAMI Level 4 perANSI/AAMI PB70:2012, LiquidBarrier Performance andClassification of ProtectiveApparel and Drapes Intended forUse in Health CareFacilities, but has an open backwhich is non-protective. Testingwas performed in accordancewith ASTM F1671 using 3 lots and32 samples per lot in each criticalzone area. The critical zone areastested were the body or sleeve(same material) and the heatsealed seam(s). | ||
| SterilizationModality | None, non-sterile | None, non-sterile | Same |
| Biocompatibility-Cytotoxicity(ISO 10993-5),Irritation &Sensitization(ISO 10993-10) | • Under the conditions of thestudy, the device did not showcytotoxicity potential.• Under the conditions of thestudy, the irritation response | • Under the conditions of thestudy, the device did notshow cytotoxicity potential.• Under the conditions of thestudy, the irritation response | Same |
| category of the device wasclassified as Negligible. | category of the device wasclassified as Negligible. | ||
| • Under the conditions of thestudy, the device showed nosignificant evidence of causingskin sensitization. | • Under the conditions of thestudy, the device showed nosignificant evidence ofcausing skin sensitization. |
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Non-Clinical Test Results:
The subject protective gowns were tested and found conformance with the following standards:
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
- AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test
- ASTM F1671/F1671M-13 Standard Test Method for Resistance to Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage as a Test System
- . ANSI AAMI PB70: 2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use in Health Care Facilities
- . ASTM D5587-15 (2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
- ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State
- ASTM D1683/D1683M-17:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics
- ASTM D3776/D3776M-20 Test Methods for Mass Per Unit Area (Weight) of Woven Fabric
- . ASTM D5034-21 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
- 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
- ISO 10993-1:2018 Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within ● a risk management process
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Summary for Non-Clinical Testing:
| Test Item | TestStandardMethods | Test Requirements | Test Results of SubjectDevice Dukal AAMI Level 4Surgical GownNote: Below results are forSleeve and Body material | Remark |
|---|---|---|---|---|
| Blood-BornePathogenspenetration | ASTM F1671 | Pass (For AAMI Level 4Requirements): NoneSeen for Penetrationof Phi-X174Bacteriophage | Pass | Meetsrequirement |
| Hydrostatic pressure | AATCC 127 | ≥100cm H2O(Individual)≥140cm H2O(Average) | >130 cm H2O | Meetsrequirement |
| Basis weight | ASTM D3776 | 50±6 gsm | 50±6 gsm | Meetsrequirement |
| Tensile strength | ASTM D 5034 | Machine Direction(MD)≥ 30 NCross Direction (CD)≥ 30 N | Machine Direction (MD)≥ 30 NCross Direction (CD)≥ 30 N | Meetsrequirement |
| Tear strength | ASTM D5587 | Machine Direction(MD)≥ 10 NCross Direction (CD)≥ 10 N | Machine Direction (MD)≥ 10 NCross Direction (CD)≥ 10 N | Meetsrequirement |
| Seam Strength | ASTM D 1683 | ≥30N | ≥30N | Meetsrequirement |
| Lint generation | ISO 9073-10 | Size of particlescounted: 3mcg-25mcg | Size of particles counted:3mcg 25mcg | Meetsrequirement |
| Flammability | 16 CFR Part1610 | Class I | Class I | Meetsrequirement |
| Biocompatibility | ISO 10993-5ISO 10993-10 | -Under the conditions of the study, the device does not show cytotoxicity potential.-Under the conditions of the study, the irritation response category of the device is classified as Negligible.-Under the conditions of the study, the device shows no significant evidence of causing skin sensitization. | -Under the conditions of the study, the device did not show cytotoxicity potential.-Under the conditions of the study, the irritation response category of the device was classified as Negligible.-Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. | Meets requirement |
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Summary for Clinical Testing: Not Applicable
Conclusions: The conclusion drawn from the nonclinical tests demonstrates that the subject devices in this 510(k) submission, Dukal AAMI Level 4 Open-Back Protective Gowns, are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K182830.
§ 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.