(212 days)
"Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided sterile.
"Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back.
"Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3.
The provided text describes the 510(k) submission for the "Skypro, Surgical Gown 6021" and compares it to a predicate device. This document is a regulatory submission for a medical device (surgical gown), not a software-based AI/ML device. Therefore, the bulk of the questions, specifically those related to AI/ML device performance (like "effect size of how much human readers improve with AI vs without AI assistance," "standalone performance," "number of experts for ground truth," or "sample size for training set"), are not applicable.
However, I can extract information related to the acceptance criteria and study proving the device meets those criteria, as well as the types of testing performed for this non-AI medical device.
Here's the relevant information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document details various non-clinical tests and their criteria, which serve as the acceptance criteria for the surgical gown.
| Test Performed | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| ASTM F2407-20, Section 7.2 Tensile Strength (ASTM D5034-09(R17)) | To evaluate the tensile strength of the gown material | ≥ 30N | Pass (Warp yarns torn (MD): 179.7 N, Weft yarns torn (CD): 103.7 N) |
| ASTM F2407-20, Section 7.2 Seam Strength (ASTM D1683/D1683M-22) | To evaluate the tensile strength of the gown seam | ≥ 30N | Pass (Sleeve seam: 113.3 N, Armhole seam: 73.2 N, Shoulder seam: 111.1 N) |
| ASTM F2407-20, Section 7.2 Tearing Strength (ASTM D5733-99) | To evaluate the tear strength of the gown material | ≥ 10N | Pass (Warp yarns torn (MD): 53.9 N, Weft yarns torn (CD): 29.2 N) |
| ASTM F2407-20, Section 7.3 Lint Generation (ISO 9073-10:2003) | To evaluate the potential for linting of the gown | Documentation only | Pass (Side A (face): Total linting: 140.9, Coefficient of linting: 2.15; Side B (back): Total linting: 242.2, Coefficient of linting: 2.38) |
| ASTM F2407-20, Section 7.3 Evaporative Resistance (ASTM F1868-17) | To evaluate the evaporative resistance of the gown | Documentation only | Pass (0.00215 kPa·m²/W) |
| Water Resistance: Hydrostatic Pressure (AATCC 42:2017) | To evaluate the hydrostatic water resistance of the gown | ≥ 50cmH20 | Pass (Base material: > 50 cmH₂O, Sleeve Seam: > 50 cmH2O, Tie attachment with/without film: > 50 cmH₂O) |
| Water Resistance: Impact Penetration (AATCC 127:2018e) | To evaluate the water spray resistance of the gown | ≤ 1.0g | Pass (Base material: 0 g, Sleeve Seam: 0 g, Tie attachment with/without film: 0 g; No penetration can be observed) |
| ASTM F2407-20, Section 6.3 Flame Spread (16 CFR 1610) | To evaluate the flame resistance of the gown | Class 1 | Pass (Class 1) |
| Cytotoxicity Test: MEM Elution (ISO 10993-5:2009) | To evaluate the cytotoxic potential of the gown | Under conditions of the testing, non-cytotoxic | Pass (Under conditions of the testing, non-cytotoxic) |
| Sensitization Test: Kligman Maximization Test (ISO 10993-10:2021) | To evaluate the sensitization potential of the gown | Under conditions of the testing, not a sensitizer | Pass (Under conditions of the testing, not a sensitizer) |
| Primary Skin Irritation Test: Intracutaneous Injection Test (ISO 10993-10:2021) | To evaluate the skin irritation potential of the gown | Under conditions of the testing, not an irritant | Pass (Under conditions of the testing, not an irritant) |
| Sterilant Gas Residue Analysis (ISO 10993-7) | To verify low levels of residual ethylene oxide and ethylene chlorohydrin | EO: < 4 mg /device; ECh: < 9 mg / device | Pass (EO: < 4 mg /device, ECh: < 9 mg / device) |
| Seal Peel Test (ASTM F88) | To evaluate the force necessary to open the sterile barrier seals | 0.375 lbf (average) | Pass (0.375 lbf (average)) |
| Dye Migration Test (ASTM F1929) | To verify the integrity of the sterile barrier | No leakage | Pass (No leakage) |
| Simulated Aging Test (ASTM F1980) | To verify the ability of the sterile barrier to maintain integrity during its shelf life | Meets performance specifications after accelerated aging, no visually apparent change | Pass (Meets performance specifications after accelerated aging, no visually apparent change) |
| AAMI PB 70 Classification | To classify the gown's barrier performance | Level 3 | Level 3 |
| Sterility Assurance Level | To ensure microbial sterility | 10^-6 | 10^-6 |
| Shelf Life | To define the time during which the product remains safe and effective | Stated Shelf Life (e.g., 2 years) | 2 years |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test. It refers to standard ASTM and ISO methods, which typically dictate sample sizes. The data provenance is not explicitly stated in terms of country of origin, nor is it specified as retrospective or prospective; these are standard laboratory tests on the manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is for a physical medical device (surgical gown), not an AI/ML device relying on expert interpretation for ground truth. The "ground truth" here is objective physical and chemical properties measured by standardized test methods.
4. Adjudication method for the test set
Not applicable. This is for a physical medical device. The results are from standardized laboratory testing, not subjective human-reviewed data requiring adjudication.
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 is not an AI/ML device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The ground truth is established through adherence to recognized international (ISO) and national (ASTM, AATCC, 16 CFR) standards and test methods for material properties, barrier performance, biocompatibility, and sterility. These are objective, measurable outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.
October 12, 2023
Skypro Medical Supplies Company Cyrus Wong General Manager C301, Tsing Yi Industrial Centre Phase 2. 1-33 Cheung Tat Road, Tsing Yi, N.T. Hong Kong. China
Re: K230707
Trade/Device Name: Skypro, Surgical Gown 6021 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 14, 2023 Received: September 14, 2023
Dear Cyrus Wong:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the text "Bifeng Qian -S" in a simple, sans-serif font. The text is arranged horizontally, with "Bifeng" and "Qian" being the most prominent words. The "-S" is smaller and slightly offset to the right. The background is plain white.
BiFeng Qian, M.D., 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
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Indications for Use
510(k) Number (if known) K230707
Device Name Skypro, Surgical Gown 6021
Indications for Use (Describe)
"Skypro. Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single use, disposable, and provided 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) Summary K230707
This 510(k) summary information is submitted in accordance with the requirements of 21 CFR 807.92.
l. Submitter
Company: Skypro Medical Supplies Company Address: Flat C301, 3/F, Block C, Phase 2, Tsing Yi Industrial Centre, 1-33 Cheung Tat Road, Tsing Yi, New Territories, Hong Kong, P. R. China Contact Person: Cyrus Wong (General Manager) Phone No.: 852-27110882 Fax No.: 852-27110116 Email: cyrus@skypro-med.com Date Prepared: October 12, 2023
US Agent and Correspondent of the Submitter: Company: SKYPRO MEDICAL SUPPLIES USA LTD COMPANY Address: 5722 Kendall Hill Ln, Sugar Land, TX 77479 Contact Person: Eve Luo Email: Eve@1masks.com Phone No.: 832-312-2668 EIN/TAX ID: 851587593
II. Device
Device Manufacturer: SPRO Medical Products (Xiamen) Co., Ltd Address: No.139 Factory Building, TongAn Garden, TongAn Industrial Area, Xiamen, Fujian Province, 361100, P. R. China Device Trade Name: Skypro, Surgical Gown 6021 Regulation Name (Number): Surgical Apparel (21 CFR 878.4040) Class: Class II Classification Panel: General and Plastic Surgery Product Code: FYA Device Common Name/ Classification Name: Surgical Gown
III. Predicate Device
K162442 This predicate has not been subject to a design-related recall. Device Trade Name: ComfortGuard Surgical Gown, i500 Regulation Name (Number): Surgical Apparel (21 CFR 878.4040) Class: Class II Classification Panel: General and Plastic Surgery Product Code: FYA Device Common Name/ Classification Name: Surgical Gown
IV. Device Description
1
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"Skypro, Surgical Gown 6021" are sterile, disposable, and intended for single use. They are fundamentally made of blue non-woven spunbond-meltblown-spunbond (SMS) polypropylene fabrics, and come in a variety of sizes (XS, S, M, L, XL, and XXL). The gown features white elastic cuffs, a hook-and-loop tap for closing the neck, and four waist belts for closing the back.
"Skypro, Surgical Gown 6021" is constructed in accordance with AAMI PB70 Level 3 specifications. The major raw material of the surgical gown is non-woven SMS polypropylene fabric, which is a trilaminate non-woven fabric with a densely packed structure (i.e., small micron pore sizes) to provide tortuous paths to block the penetration of particulate matter. The hydrophobic nature of the fabric can effectively prevent the absorption and penetration of liquids and body fluids. The joints and seam regions of the surgical gown are sealed via ultrasonic vibration- assisted welding to avoid the penetration of liquids through joints and seam stitching. The whole of the surgical gown exhibits a barrier performance of Level 3.
V. Indications for Use/ Intended Use
"Skypro, Surgical Gown 6021" are intended to protect both surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. They are classified as Level 3 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gown is single-use, disposable, and provided sterile.
| Description | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| K162442"ComfortGuard SurgicalGown, i500" | K230707"Skypro, Surgical Gown 6021" | ||
| Indications for Use | ComfortGuard SurgicalGown, i500 are single usesurgical gowns intended toprotect surgical patientsand operating roompersonnel from thetransfer of microorganisms,body fluids, and particulatematerial.ComfortGuard SurgicalGown, i500 have beentested and are classified asLevel 3 in the critical zonesper AAMI Standard PB70Liquid barrier performanceand classification ofprotective apparel anddrapes intended for use inhealthcare facilities. | "Skypro, Surgical Gown 6021"are intended to protect bothsurgical patients and operatingroom personnel from thetransfer of microorganisms,body fluids, and particulatematerial. They are classified asLevel 3 surgical gowns inaccordance with ANSI/AAMIPB70 and used in healthcarefacilities. The gown is single-use, disposable, and providedsterile. | Similar |
| Design | Neck binder, hook-and-loop neck closures. belt | Raglan sleeves, hook-and-loopneck closures. and tie waist | Same |
| ties, removable transferaccessory, and cuffs. | closures | ||
| Material | Single-layer nonwovenSMS polyolefin fabricsthroughout the entiregown, with no additionalreinforcement | Non-woven SMS polypropylenefabrics throughout the entiregown, with no additionalreinforcement | Same |
| Color | Blue | Blue | Same |
| Performance Characteristics | |||
| AAMI PB 70Classification | Level 3 | Level 3 | Same |
| Tensile Strength(ASTM D5034 orASTM D5035) | Body/sleeve material:- MD: 82.8 N- CD: 58.54 NBack material:- MD: 89.52 N- CD: 56.32 N | Warp yarns torn (MD): 179.7 NWeft yarns torn (CD): 103.7 N | Similar |
| Seam Strength(ASTMD16836/D1683M-17) | Sleeve seam: ≥ 15 NArmhole seam:Experimental data are notavailableShoulder seam:Experimental data are notavailable | Sleeve seam: 113.3 NArmhole seam: 73.2 NShoulder seam: 111.1 N | DifferentData is notavailable forthe predicatedevice. Datademonstratessubject devicecomplies withASTM F2407. |
| Tearing Strength(ASTM D5587) | Body/sleeve material- MD:19.01 N- CD: 28.14 NBack material- MD: 21.19 N- CD: 37.00 N | Warp yarns torn (MD): 53.9 NWeft yarns torn (CD): 29.2 N | Similar |
| Lint Generation(ISO 9073-10) | Not stated | Side A (face):Total linting: 140.9Coefficient of linting: 2.15Side B (back):Total linting: 242.2Coefficient of linting: 2.38 | DifferentData is notavailable forthe predicatedevice. |
| EvaporativeResistance (ASTMF1868-17) | Not stated | 0.00215 kPa·m²/W | DifferentData is notavailable forthe predicatedevice. |
| Water Resistance:Hydrostatic Pressure(AATCC 127 andANSI/AAMI PB70) | Base material: 657 mmH2OSleeve seam: 760 mmH2OTie attachments: 668mmH₂O | Base material: > 50 cmH₂OSleeve Seam: > 50 cmH2OTie attachment with/withoutfilm: > 50 cmH₂O | Similar |
| Water Resistance:Impact Penetration(AATCC 42 andANSI/AAMI PB70) | Base material: 0.04 gSleeve seam: 0.04 gTie attachments: 0.02 gNo penetration can beobserved | Base material: 0 gSleeve Seam: 0 gTie attachment with/withoutfilm: 0 gNo penetration can beobserved | Similar |
| Flammability Class 16CFR Part 1610 | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| Cytotoxicity | Under conditions of thetesting, non-cytotoxic | Under conditions of the testing,non-cytotoxic | Same |
| Sensitization | Under conditions of thetesting, not a sensitizer | Under conditions of the testing,not a sensitizer | Same |
| Primary SkinIrritation | Under conditions of thetesting, not an irritant | Under conditions of the testing,not an irritant | Same |
| Sterility and Shelf Life | |||
| Sterilization | Sterile; single-use | Sterile; single-use | Same |
| Sterility AssuranceLevel | Not stated | 10-6 | DifferentData is notavailable forpredicatedevice. Datademonstratessubject devicehasacceptablesterilityassurancelevel. |
| Sterilization modality | Ethylene Oxide | Ethylene Oxide | Same |
| Sterilant Residuals | Not stated | EO: < 4 mg /deviceECh: < 9 mg / device | DifferentData is notavailable forpredicatedevice. Datademonstratessubject devicedoes not haveexcessivesterilantresiduals. |
| Shelf Life | Not stated | 2 years | DifferentThe predicatedoes not havea stated shelflife. |
VI. Comparison of Technological Characteristics with the Predicated Device
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The differences in the Indications For Use do not impact the safety or effectiveness of the gown. The additional data provided for the subject gown, including the tensile properties
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of the armhole and shoulder seam, the lint generation and evaporative resistance, and the Sterility Assurance Level and sterilant residuals provide additional confidence in gown safety and performance. Designation of a shelf life provides confidence that the subject device will maintain performance properties throughout its listed shelf life.
VII. Summary of Non-Clinical Testing
| Test Performed | Purpose | Criteria | Result |
|---|---|---|---|
| 1. ASTM F2407-20, Section 7.2 Tensile StrengthASTM D5034-09(R17) | To evaluate the tensile strength of the gown material | ≥ 30N | Pass |
| 2. ASTM F2407-20, Section 7.2 Seam StrengthASTM D1683/D1683M-22 | To evaluate the tensile strength of the gown seam | ≥ 30N | Pass |
| 2. ASTM F2407-20, Section 7.2 Tearing StrengthASTM D5733-99 | To evaluate the tear strength of the gown material | ≥ 10N | Pass |
| 3. ASTM F2407-20, Section 7.3 Lint GenerationISO 9073-10:2003 | To evaluate the potential for linting of the gown | Documentation only | Pass |
| 4. ASTM F2407-20, Section 7.3 Evaporative ResistanceASTM F1868-17 | To evaluate the evaporative resistance of the gown | Documentation only | Pass |
| 5. Water Resistance:Hydrostatic PressureAATCC 42:2017 | To evaluate the hydrostatic water resistance of the gown | ≥ 50cmH20 | Pass |
| 6. Water Resistance:Impact PenetrationAATCC 127:2018e | To evaluate the water spray resistance of the gown | ≤ 1.0g | Pass |
| 7. ASTM F2407-20, Section 6.3 Flame Spread16 CFR 1610 | To evaluate the flame resistance of the gown | Class 1 | Pass |
| 8. Cytotoxicity Test: MEM ElutionISO 10993-5:2009 | To evaluate the cytotoxic potential of the gown | Under conditions of the testing, non-cytotoxic | Pass |
| 9. Sensitization Test: Kligman Maximization TestISO 10993-10:2021 | To evaluate the sensitization potential of the gown | Under conditions of the testing, not a sensitizer | Pass |
| 10. Primary Skin Irritation Test:Intracutaneous Injection TestISO 10993-10:2021 | To evaluate the skin irritation potential of the gown | Under conditions of the testing, not an irritant | Pass |
| 11. Sterilant Gas Residue AnalysisISO 10993-7 | To verify low levels of residual ethylene oxide and ethylene chlorohydrin | EO: < 4 mg /deviceECh: < 9 mg / device | Pass |
| 12. Seal Peel TestASTM F88 | To evaluate the force necessary to open the sterile barrier seals | 0.375 lbf (average) | Pass |
| 13. Dye Migration Test | To verify the integrity | No leakage | Pass |
| ASTM F1929 | of the sterile barrier | ||
| 14. Simulated Aging TestASTM F1980 | To verify the ability ofthe sterile barrier tomaintain integrityduring its shelf life | Meets performancespecifications afteraccelerated aging, novisually apparentchange | Pass |
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VIII. Clinical Testing
No clinical testing was performed in support of this submission.
lX. Conclusions
The conclusions drawn from the non-clinical tests demonstrate that the subject device, Skypro, Surgical Gown 6021, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K162442.
§ 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.