(354 days)
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 material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical 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 Surgical Gowns are single use, disposable medical devices; provided sterile or non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Surgical Gown is designed for the medical personnel using in operation. The employed material is SMS compound non-woven fabric. The material has many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff, they don't have any peculiar smell, other matters and primary color. The gowns are for safe use in the operating room environment, i.e., lint free, free of toxic ingredients and non-fast dyes. It is a kind of Non- Reinforced surgical gown. The chest front and sleeve critical zones of the Disposable Surgical Gowns are constructed from a blue polyolefin SMS (spunbond, meltblown, spunbond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown. The Disposable Surgical Gown is a single use, disposable medical device that will be provided in a variety of nonsterile packaging configurations.
The provided text describes the 510(k) summary for Disposable Surgical Gowns (K202532). It details non-clinical testing conducted to demonstrate substantial equivalence to a predicate device (K170762).
Here's the breakdown of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Disposable Surgical Gowns are primarily based on meeting the performance requirements for AAMI Level 3 barrier protection as per ANSI/AAMI PB70:2012, along with other physical properties and biocompatibility.
| Testing Methodology / Parameter | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Barrier Protection | |||
| Hydrostatic Pressure (AATCC 127:2014) | ≥ 50 cm H2O | Average of 203 cm on Front body material, 168 cm on back body material, and 60 cm on seam. | PASS |
| Water Impact (AATCC 42:2013) | ≤ 1.0 g | 0g on Critical Zone (Body material, Sleeve seam and Adhesive part of belt) | PASS |
| Level (AAMI PB70) | Level 3 | Level 3 | Same as Predicate |
| Resistance to blood and liquid penetration (AAMI PB70) | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same as Predicate |
| Physical Properties | |||
| Tear strength (N) (Trapezoid Method, ASTM D 5587-2015) | MD/CD ≥ 10N | MD Mean 60.4N, CD Mean 40.2N | PASS |
| Breaking Strength (ASTM D 5034-2009(2017)) | MD/CD ≥ 30N | MD Mean (not reported for proposed device), CD Mean 88.2N | PASS |
| Sewn seam strength (sleeve seam) (ASTM D1683/D1683M-2017(2018)) | Seam Strength ≥ 30N | Seam Strength Mean: 64.5 N | PASS |
| Water-vapor resistance (ASTM F 1868-2017) | ≤ 3.0 Pa·m²/W | Mean: 2.42 Pa·m²/W | PASS |
| Lint and other particles generation in dry state (ISO 9073-10: 2003) | Coefficient of linting Log10 ≤ 4.0 | Log10 Mean: 3 | PASS |
| Burning Behavior (16 CFR Part 1610) | Class I | Class I | PASS |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5: 2009) | Non-Cytotoxic | Device is non-cytotoxic. | PASS |
| Irritation (ISO 10993-10: 2010) | Non-Irritating | Device is non-irritating. | PASS |
| Sensitization (ISO 10993-10: 2010) | Non-Sensitizing | Device is non-sensitizing. | PASS |
2. Sample sizes used for the test set and the data provenance
The document specifies the following sample sizes for the non-clinical tests:
- Hydrostatic Pressure (AATCC127:2014): 3 non-consecutive lots tested, using a sample size of 32/lot.
- Water-proof Property (AATCC42:2013): 3 non-consecutive lots tested, using a sample size of 32/lot.
- Tear strength (Trapezoid Method, ASTM D 5587-2015): Sample size of 5 pcs.
- Breaking Strength (ASTM D 5034-2009(2017)): Sample size of 8 pcs.
- Sewn seam strength (sleeve seam) (ASTM D1683/D1683M-2017(2018)): Sample size of 5 pcs.
- Water-vapor resistance (ASTM F 1868-2017): Sample size of 3 pcs.
- Lint and other particles generation in the dry state (ISO 9073-10: 2003): Sample size of 5 pcs.
- Mass per unit area (ASTM D3776/D3776M-2009(2017)): Sample size of 5 pcs.
- Burning Behavior (16 CFR Part 1610): Sample size of 5 pcs.
- Biocompatibility (Cytotoxicity, Irritation, Sensitization): Specific sample sizes are not explicitly stated, but the tests were performed according to ISO 10993-5 and ISO 10993-10.
Data Provenance: The document states that the non-clinical tests were conducted to verify that the proposed device met design specifications. Given the applicant's address (Anhui Medpurest Medical Technology Co.,Ltd, China) and the submission correspondent's address (Shanghai SUNGO Management Consulting Co., Ltd, China), it can be inferred that the testing was performed in China or by labs contracted by the applicant. The data is retrospective in nature, as it's a summary of tests already performed for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes non-clinical performance and biocompatibility testing for a physical medical device (surgical gowns). It does not involve diagnostic image analysis or clinical interpretation. Therefore, the concept of "experts establishing ground truth for a test set" in the context of medical image analysis or similar tasks is not applicable here. The ground truth for these tests is established by standardized testing methodologies and instruments as defined by the listed ASTM, AATCC, ISO, and CPSC standards.
4. Adjudication method for the test set
As this is non-clinical performance and material property testing, an adjudication method (like 2+1 or 3+1) is not applicable. The results are quantitative measurements obtained through defined protocols. Pass/Fail criteria are based on exceeding or falling below specified thresholds in the relevant standards.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human interpretation is assisted by AI. This submission is for a physical medical device (surgical gowns), and no AI component is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not done in the context of an algorithm. This submission is for a physical medical device (surgical gowns) and does not involve an algorithm. The "standalone" performance here refers to the physical and barrier properties of the gown itself, which are measured directly through the non-clinical tests.
7. The type of ground truth used
The ground truth for this device's performance is established by standardized laboratory testing and measurements based on the referenced national and international standards (e.g., AAMI, ANSI, ASTM, AATCC, ISO, CPSC). For example:
- For barrier protection, the ground truth is the measured hydrostatic pressure and water impact performance against the specified level (AAMI Level 3).
- For physical properties like tear strength and breaking strength, the ground truth is the force required to tear or break the material as measured by testing machines.
- For biocompatibility, the ground truth is the measured biological response (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization) compared to established toxicity thresholds.
8. The sample size for the training set
Not applicable. This submission is for a physical medical device (surgical gowns) and does not involve AI/machine learning, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned or implied for this device, the method for establishing ground truth for a training set is irrelevant.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 21, 2021
Anhui Medpurest Medical Technology Co.,Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K202532
Trade/Device Name: Disposable Surgical Gowns Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: July 15, 2021 Received: August 11, 2021
Dear Ivy Wang:
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 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,
Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202532
Device Name Disposable Surgical Gowns
Indications for Use (Describe)
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 material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical 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 Surgical Gowns are single use, disposable medical devices; provided sterile or non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization to ISO 11135-1.
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
Document prepared date: 8/21/2021
A. Applicant:
Anhui Medpurest Medical Technology Co.,Ltd Address: No.188, Wenyuan Road, Zhumeng New Zone, Anging, Anhui Province, China Contact Person: Yang Yang Tel : +86-556-5999022 Fax : +86-556-5999022
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@@gmail.com
B. Device: Trade Name: Disposable Surgical Gowns Common Name: Surgical Gown Model(s): MDSG-1052
Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K170762 Cardinal Health™ Non-Reinforced Surgical Gown Cardinal Health 200, LLC
D. Intended use of the device:
Disposable Surgical Gowns are intended to be worn by operating room personnel during
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surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. This surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical 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 Surgical Gowns are single use, disposable medical devices; provided sterile or non-sterile. Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EtO) sterilization according to ISO 11135-1 prior to marketing to the end users and Sterile surgical gowns are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
E. Device Description:
Surgical Gown is designed for the medical personnel using in operation. The employed material is SMS compound non-woven fabric. The material has many good properties, such as soft, clean, good filtration and uniformity and waterproof, they are not sensitive to human beings, difficult to fluff, they don't have any peculiar smell, other matters and primary color. The gowns are for safe use in the operating room environment, i.e., lint free, free of toxic ingredients and non-fast dyes. It is a kind of Non- Reinforced surgical gown.
The chest front and sleeve critical zones of the Disposable Surgical Gowns are constructed from a blue polyolefin SMS (spunbond, meltblown, spunbond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown. The Disposable Surgical Gown is a single use, disposable medical device that will be provided in a variety of nonsterile packaging configurations.
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Manufacturer | Anhui Medpurest MedicalTechnology Co.,Ltd | Cardinal HealthTM | - |
| 510K number | K202532 | K170762 | - |
| Model Name | Disposable Surgical Gowns | Cardinal HealthTM Non-ReinforcedSurgical Gown | - |
| Classification | Class II Device, FYA (21CFR878.4040) | Class II Device, FYA (21CFR878.4040) | Same |
F. Technological Characteristic Comparison
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| Intend use | Disposable Surgical Gowns | Cardinal Health™ Non-Reinforced Surgical Gown is | Same |
|---|---|---|---|
| are intended to be worn byoperating room personnelduring surgical procedures toprotect the surgical patientand operating roompersonnel from the transferof microorganisms, bodyfluidsand particulate material.This surgical gown meetsthe requirements ofAAMI Level 3 barrierprotection for a surgical | intended to be worn byoperating room personnelduring surgical procedures toprotect the surgical patient andoperating room personnelfrom the transfer ofmicroorganisms, body fluidsand particulate material. Inaddition, this surgical gownmeets the requirements ofAAMI Level 3 barrierprotection for a surgical gown | ||
| gown per ANSI/AAMIPB70:2012Liquid barrierperformance andclassification of protectiveapparel and drapes intendedfor use in health carefacilities (AAMI PB70). TheSurgical Gowns are singleuse, disposablemedical devices; providedsterile or non-sterile. Non-sterile gowns are to be sold tore-packager/re-labelerestablishments for ethyleneoxide (EtO) sterilizationaccording to ISO 11135-1 priorto marketing to the end usersand Sterile surgical gowns areto be sold directly to users afterEtO sterilization validation toISO 11135-1. | per ANSI/AAMI PB70:2012Liquid barrier performanceand classification of protectiveapparel and drapesintended for use in healthcare facilities (AAMIPB70). The CardinalHealth™ Non-ReinforcedSurgicalGowns are single use,disposable medical devices;provided sterile and non-sterile. | ||
| MaterialComposition | Polyolefin (Polypropylene)SMS nonwoven | Polyolefin (Polypropylene)SMS nonwoven | Same |
| Sterility | Non-Sterile | Sterile and Non-sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color | Blue | Blue | Same |
| Size | S,M,L,XL,XXL | M-S, M, L, XL, XXL | Same |
| Weight persquare(g) | $45 g/m^2$ | $31g/m^2$ (1.32 oz/yd2) | Similar |
| Tensile | MD Mean 123.4NCD Mean 88.2N | MD Mean 21.57 lbsCD Mean 13.6 lbs | Similar |
| Tear | MD Mean 60.4NCD Mean 40.2N | MD Mean 3.47 lbsCD Mean 5.63 lbs | Similar |
| HydrostaticPressure(cm)AATCC-127 | $>50 cm$ | $>50 cm$ | Same |
| Water Impact (g)AATCC-42 | $\le 1.0 g$ | $\le 1.0 g$ | Same |
| Level | Level 3 | Level 3 | Same |
| Resistance toblood and liquidpenetration | Level 3 AAMI PB70 | Level 3 AAMI PB70 | Same |
| EtO/ECHResiduals | Device is naturally degassingfor 48 hours, both EtO andECH residuals below thedetection limit(0.03µg/g) | No available on PredicateDevice's 510(k) Summary | Similar |
| Shelf-life | 3 years | No available on PredicateDevice's 510(k) Summary | Similar |
| Biocompatibility | Under the conditions of the study, the device extract was notcytotoxic. Under the conditions of the study, the non-polar andpolar device extracts were not found to be an irritant.Under conditions of the study, the non-polar and polar deviceextracts were not found to be a sensitizer. | Same |
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G. Non-Clinical Test Conclusion
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:
- A 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
-
CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
-
AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test;
- A AATCC 42-2013, Water Penetration Resistance: Impact Penetration Test;
-
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test):
- 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 Apparel and Drapes Intended For Use In Health Care Facilities.
Table 2 - Performance Testing
| Testing Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Hydrostatic PressureAATCC127:2014 | The purpose of theperformance testing is todemonstrate thefunctionality of thesubject device. | ≥50cm H2O | PASS3 non-consecutive lotstested, using a samplesize of 32/lot. |
| Average of 203cm onFront body material,168cm on back bodymaterial and 60cm onseam. |
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| Water-proof PropertyAATCC42:2013 | ≤1.0g | PASS3 non-consecutive lotstested, using a samplesize of 32/lot.0g on Critical Zone(Body material, Sleeveseam and Adhesive partof belt) |
|---|---|---|
| Tear strength(N)Trapezoid MethodASTM D 5587-2015, | MD/CD≥ 10N | PASSSample size of 5 pcsMD Mean 60.4NCD Mean 40.2N |
| Breaking StrengthASTM D 5034-2009(2017) | MD/CD≥ 30N | PASSSample size of 8 pcsCD Mean 88.2N |
| Sewn seamstrength (sleeveseam) ASTMD1683/D1683M-2017(2018) | Seam Strength ≥ 30N | PASSSample size of 5 pcsSeam Strength Mean:64.5 N |
| Water-vaporresistanceASTM F 1868-2017 | ≤3.0 Pa·m²/W | PASSSample size of 3 pcsWater-vapor resistanceMean: 2.42 Pa·m²/W |
| Lint and otherparticles generation inthe dry stateISO 9073- | Coefficientof linting Log10≤ 4.0 | PASSSample size of 5 pcsLog10 Mean: 3 |
| 10: 2003Mass per unit areaASTMD3776/D3776M-2009(2017) | N/A | Sample size of 5 pcs. Masper unit area Mean: 45g/m² |
| Burning Behavior16 CFR Part 1610 | Class I | PASSSample size of 5 pcsClass I |
Table 3 Biocompatibility Testing
| Item | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ------ | --------- | --------------------- | -------- |
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| Cytotoxicity | The purpose of the biocompatibility testing is to demonstrate the biocompatibility of the subject device. | Non-Cytotoxic | PASSUnder the conditions of the study, the device is non-cytotoxic. |
|---|---|---|---|
| Irritation | Non-Irritating | PASSUnder the conditions of the study, the device is non-irritating. | |
| Sensitization | Non-Sensitizing | PASSUnder the conditions of the study, the device is non-sensitizing |
H. Clinical Test Conclusion
No clinical study is included in this submission.
L Conclusion
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Disposable Surgical Gowns cleared under K170762.
§ 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.