(56 days)
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided sterile.
Disposable Isolation Gowns are designed for the medical personnel use in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown. The Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are blue color, sterilized by ethylene oxide gas , single use, disposable medical device that will be provided in a variety of sterile packaging configurations with 6 sizes, S,M,L,XL,XXL,and XXXL
The provided document describes the acceptance criteria and the results of non-clinical tests for the "Disposable Isolation Gowns" (K223411) from Xiamen Probtain Medical Technology Co., Ltd.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Seam strength | ASTM D1683M-17 Standard Test Method for Failure in Sewn Seams of Woven Fabrics. | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (89.86 N, average from 10 samples) |
| Breaking strength | ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) | ≥30N (7lbf) per standard F2407-20 for level 3 | PASS (MD: 90.92 N, CD: 77.06 N, average from 10 samples) |
| Tear strength (N) | ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure | ≥10N | PASS (MD: 31.89 N, CD: 19.2 N, average from 10 samples) |
| Lint and other generation in the dry state | ISO 9073-10: 2003 Textiles - Test Methods for Nonwovens - Part 10: Lint and Other Particles Generation in the Dry State | Log10(particle count) < 4 | PASS (1.8, average from 10 samples) |
| Flammability | CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles | Class I | PASS (Class I) |
| Water Penetration Resistance | AATCC 42-2013, Impact Penetration Test | ≤1.0g AQL: 4% Level 3 per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≤1.0g) |
| Static hydrostatic resistance | AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test | ≥50 cmH2O per standard ANSI/AAMI PB70:2012 for level 3 | PASS (≥50 cmH2O) |
| EO and ECH sterilization residual | ISO 10993-7:2008 Ethylene oxide sterilization residuals | EO ≤ 4mg/d, ECH ≤ 9mg/d | PASS (EO ≤ 4mg/d, ECH ≤ 9mg/d) |
| Biocompatibility: Cytotoxicity | ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity (The test was performed under the conditions of the study, the device extract was not cytotoxic.) | Non-Cytotoxic | PASS (Under the conditions of the study, the device is non-cytotoxic.) |
| Biocompatibility: Irritation | ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization (The test was performed under the conditions of the study, the non-polar and polar device extracts were not found to be an irritant.) | Non-Irritating | PASS (Under the conditions of the study, the device is non-irritating.) |
| Biocompatibility: Sensitization | ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization (Under conditions of the study, the non-polar and polar device extracts were not found to be a sensitizer.) | Non-Sensitizing | PASS (Under the conditions of the study, the device is non-sensitizing.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Mechanical/Physical Tests: For most mechanical and physical tests (Seam strength, Breaking strength, Tear strength, Lint and other generation), the results are reported as an "Average result from 10 samples."
- Sample Size for Biocompatibility Tests: Not explicitly stated but generally follows ISO 10993 standards which define sample sizes.
- Data Provenance: The tests were conducted to verify that the proposed device met design specifications. The document does not specify the country of origin of the testing data beyond listing the applicant's address in Xiamen, Fujian, China. The studies are non-clinical (laboratory-based performance and safety tests), not related to patient data, so "retrospective or prospective" does not apply in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a medical device (isolation gown), not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for these tests is established by adherence to recognized international and national standards (e.g., AAMI, ASTM, ISO, CPSC). The experts involved would be laboratory technicians and engineers who are qualified to perform these specific standard tests, but their specific number or qualifications are not detailed in this submission as it's not relevant for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically for clinical studies or studies involving human readers/interpreters. This document describes non-clinical laboratory testing of a physical product against established performance standards. Therefore, an adjudication method is not applicable and not mentioned.
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
No, an MRMC comparative effectiveness study was not done. This device is a disposable isolation gown, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This is not an algorithmic device. The "standalone" performance here refers to the physical gown's performance against defined standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is defined by the acceptance criteria specified in recognized industry standards (e.g., AAMI PB70:2012, ASTM D1683M-17, ISO 10993). Therefore, it's a standards-based ground truth.
8. The sample size for the training set
This is a physical medical device (isolation gown) undergoing non-clinical performance and biological safety testing, not a machine learning model. Therefore, there is no "training set" in the context of AI or algorithms.
9. How the ground truth for the training set was established
As explained in point 8, there is no training set for this type of device.
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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 4, 2023
Xiamen Probtain Medical Techology Co., Ltd Jianli Kang Vice General Manager 4th Floor, No.1 Building, No.6 Ji'an Road, Tong'an District Xiamen, Fujian 361100 China
Re: K223411
Trade/Device Name: Disposable Isolation Gowns (S,M,L,XL,XXL,XXL) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: December 12, 2022 Received: December 12, 2022
Dear Jianli Kang:
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,
Bifeng Qian -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Disposable Isolation Gowns (S.M.L.XL.XXL.XXXL)
Indications for Use (Describe)
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAM PB70). The Disposable Isolation Gowns are single use, disposable medical devices, 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)
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510(K) Summary
K223411
Document prepared date: 2022/12/19
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 Tel: +86-592-7557106 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 Isolation Gowns Common Name: Surgical Isolation Gown Model: S,M,L,XL,XXL,XXL,XXXL
Regulatory Information Classification Name: Surgical Isolation Gown Classification: Class II Product code: FYC Regulation Number: 21 CFR 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K210785
Disposable Surgical Isolation Gowns Chongqing Litai Fashion Group Limited Company
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D. Intended use of the device/ Indications for Use:
Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gown meets the requirements of AAMI Level 3 barrier protection for a surgical isolation gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Disposable Isolation Gowns are single use, disposable medical devices, provided sterile.
E. Device Description:
Disposable Isolation Gowns are designed for the medical personnel use in medical environment, not intended for use in the operating room. The employed material is Polypropylene(PP) non-woven with polyethylene(PE) lamination. It is a kind of Non- Reinforced isolation gown.
The Disposable Isolation Gowns are constructed from a blue PP&PE (non-woven fabric, PE lamination) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical isolation gown. The Disposable Isolation Gowns are blue color, sterilized by ethylene oxide gas , single use, disposable medical device that will be provided in a variety of sterile packaging configurations with 6 sizes,
S,M,L,XL,XXL,and XXXL
| Device | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Manufacturer | Chongqing Litai Fashion Group Company | XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD | – |
| 510K number | K210785 | K223411 | – |
| Product Name | Disposable Surgical Isolation Gowns | Disposable Isolation Gowns | – |
| Product Code | FYC | FYC | Same |
| Classification | Class II Device, FYC (21 CFR878.4040) | Class II Device, FYC (21 CFR878.4040) | Same |
| Intend use/ Indications for use | Disposable Surgical Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Surgical Isolation Gowns meets the requirements of AAMI Level 3 barrier | Disposable Isolation Gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. This Disposable Isolation Gowns meets the requirements of AAMI Level 3 barrier protection for a surgical | Same |
| protection for a surgicalisolation gown perANSI/AAMI PB70:2012Liquid barrier performanceand classification of protectiveapparel and drapes intendedfor use in health care facilities(AAMI PB70). TheDisposable Surgical IsolationGowns are single use,disposable medical devices;provided non-sterile. | isolation gown per ANSI/AAMIPB70:2012 Liquid barrierperformance and classificationof protective apparel and drapesintended for use in health carefacilities (AAMI PB70). TheDisposable Isolation Gowns aresingle use, disposable medicaldevices, provided sterile. | ||
| MaterialComposition | Sleeve/body (polyethyleneSMS Nonwoven )Cuff (Polyester ) | Sleeve/body (PP non-wovenfabric & PE lamination )Cuff (Polyester ) | Similar |
| Color | Blue | Blue | Same |
| Sterility | Non-Sterile | Sterile, Ethylene Oxide (EtO) | Different |
| SterilizationMethod | Not available | Ethylene Oxide (EtO) | Different |
| SterilizationResiduals | Not available | EO ≤ 4mg/dayECH ≤ 9mg/day | Different |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Liquid BarrierPerformanceClassificationProperties | Level 3 AAMI PB70 | Level 3 AMI PB70 | Same |
| WaterPenetrationResistanceAATCC 42 | ≤1.0g AQL: 4%Level 3 per standardANSI/AAMIPB70:2012 for level 3 | ≤1.0g AQL: 4%Level 3 per standardANSI/AAMIPB70:2012 for level 3 | Same |
| StatichydrostaticresistanceAATCC 127 | ≥50 cmH2O perstandard ANSI/AAMIPB70:2012 for level 3 | ≥50 cmH2O perstandard ANSI/AAMIPB70:2012 for level 3 | Same |
| Seam strengthASTMD1683M-17 | ≥30N(7lbf)per standardF2407-20 for level 3 | ≥30N(7lbf)per standardF2407-20 for level 3 | Same |
| BreakingstrengthASTMD5034-09 | ≥30N(7lbf)per standardF2407-20 for level 3 | ≥30N(7lbf)per standardF2407-20 for level 3 | Same |
| Tearstrength(N) | ≥10N | ≥10N | Same |
| ASTMD5587-15,Flammability ofClothingTextiles- 16CFRPart 1610 | |||
| Class I | Class I | Class I | Same |
| Biocompatibility | Under the conditions of thestudy, the device extract wasnot cytotoxic.Under the conditions of thestudy, the non-polar and polardevice extracts were notfound to be an irritant.Under conditions of thestudy, the non-polar and polardevice extracts were notfound to be a sensitizer. | Under the conditions of thestudy, the device extract wasnot cytotoxic.Under the conditions of thestudy, the non-polar and polardevice extracts were not foundto be an irritant.Under conditions of the study,the non-polar and polar devicextracts were not found to be asensitizer. | Same |
F. Comparison with predicate device
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Different analysis:
The Proposed Device Disposable Isolation Gowns are provided sterile, which is different from Predicate Device's sterility. The EO and ECH Residuals tests were conducted on the proposed device to ensure its compliance to the ISO10993-7. The test result has shown the difference does not affect the safety and of the proposed device. There is no new risk generated from the difference of the sterility.
Under the conditions of each study, the Proposed Device Disposable Isolation Gowns are noncytotoxic, 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
A 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 A Textile Fabrics (Grab Test);F
A 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 A
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XIAMEN PROBTAIN MEDICAL TECHNOLOGY CO., LTD
4th Floor,No.1 Building,No.6 Ji'an Road,Tong'an District,Xiamen, Fujian,361100, China
Apparel and Drapes Intended For Use In Health Care Facilities.
-
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 Woven Fabrics
| Table 2 performance test | ||
|---|---|---|
| -- | -------------------------- | -- |
| Test Item | Test standard | Acceptance Criteria | Result |
|---|---|---|---|
| Seam strengthASTM D1683M-17Standard Test Methodfor Failure in SewnSeams of WovenFabrics. | The test was performedIn accordance withASTM D1683M-17Standard. Test Methodfor Seam Strength ofTextile Fabrics (GrabTest) to evaluate Failurein Sewn Seams of the testsample. | ≥30N(7lbf)per standardF2407-20 for level 3 | PASS89.86 N(Average result from 10samples) |
| 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: 90.92 NCD: 77.06 N(Average result from 10samples) |
| 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: 31.89 NCD: 19.2 N(Average result from 10samples) |
| 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 | PASS1.8(Average result from 10samples) |
| FlammabilityCPSC 16 CFR Part | The test was performedin accordance with 16 | Class I | PASS |
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| 1610-2008, Standardfor the Flammability ofclothing textiles | CFR Part 1610Standard for theFlammability of ClothingTextiles to evaluate theflammability of the testsample. | Class I | |
|---|---|---|---|
| Water PenetrationResistanceAATCC 42-2013,Impact Penetration Test | The test was performedin accordance withAATCC 42: 2013Water Resistance: ImpactPenetration Test toevaluate the water impactof the test sample. | ≤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 cmH2O |
| EO and ECHsterilization residualISO 10993-7:2008Ethylene oxidesterilization residuals | The test was performedin accordance with ISO10993-7:2008Ethylene oxidesterilization residuals todetermine the EO andECH residuals of the testsample | EO ≤ 4mg/dECH ≤ 9mg/d | PASSEO ≤ 4mg/dECH ≤ 9mg/d |
Table3 Biocompatibility endpoints assessment
| Test Item | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|
| CytotoxicityISO 10993-5 | Under the conditions of the study, the device isnon-cytotoxic. | Non-Cytotoxic | PASS |
| Irritation ISO10993-10 | 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.
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I. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device, Disposable Isolation Gown (model: 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 Isolation Gowns cleared under K210785.
§ 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.