(163 days)
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/A AMI 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 non-sterile.
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. The Surgical 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 zone of the Surgical Gown are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical Gown is a single use, disposable medical device that will be provided of non-sterile packaging configurations.
This is a 510(k) premarket notification for a medical device (Surgical Gown, Model: WLG1002-L3) seeking clearance from the FDA. The purpose of this submission is to demonstrate that the proposed device is substantially equivalent to a legally marketed predicate device (Cardinal Health™ Non-Reinforced Surgical Gown, K170762). Clinical performance studies are not relevant in this typical 510(k) submission, and therefore, information regarding human readers or effect sizes with AI assistance is not provided. The study focuses purely on non-clinical performance testing to meet predefined acceptance criteria.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Performance Test | Acceptance Criteria | Reported Device Performance (Example Lot #20210110) | Result |
|---|---|---|---|
| Impact Penetration (AATCC42-2017) | ≤1.0g | Front: 0.2g, Back: 0.2g, Sleeve seams: 0.2g, Side seams: 0.2g, Belt Seam: 0.1g | Pass |
| Hydrostatic Pressure (AATCC 127-2018) | ≥50 cmH2O | Front: 74.10 cmH2O, Back: 70.19 cmH2O, Sleeve seams: 70.95 cmH2O, Side seams: 73.99 cmH2O, Belt Seam: 56.10 cmH2O | Pass |
| Seam Strength (ASTM D1683/D1683M-2017(R2018)) (sleeve seam) | ≥20N (4.5lbf) | Shoulder: 71.8N, Armhole: 66.0N, Sleeve: 77.0N (General Seam Strength table shows various seam strengths, but the acceptance criteria specifically mentions sleeve seam. All reported values are well above 20N) | Pass |
| Tensile Strength (ASTM D5587-15(2019)) | ≥20N (4.5lbf) | MD: 27.8 IBS, CD: 19.1 IBS (Note: The provided text has conflicting values for Tensile strength in the two tables. The specific table for "Tensile strength, MD*" and "Tensile strength, CD*" shows values in IBS, which is pounds-force per square inch, not N. However, the acceptance criteria are in N. Assuming the "Tensile strength" row in the "Table 2 performance test" has a typo and should include directional values and units that match the acceptance criteria, or there's a conversion missing. For consistency with the acceptance criteria, the table under G. Summary of Non-Clinical Performance Testing will be used for units.) | Pass (Assuming the >20N acceptance criteria refers to the minimum of MD and CD, and 'IBS' is a typo for 'N' or a convertable unit relevant to the test.) |
| Tear Strength (ASTM D5034-09(2017)) | ≥20N | MD: 10.7 IBS, CD: 6.24 IBS (Similar to tensile strength, conflicting units. Using the acceptance criteria's unit.) | Pass (Assuming similar unit conversion or typo as tensile strength, and that the specified acceptance criteria is met by the appropriate directional value.) |
| Evaporative Resistance (ASTM F 1868-2017, Procedure Part B) | ≥30cmH2O (0.00294Kpa) | Evaporative Resistance (Ret): 0.0052 kPa.m²/W, Intrinsic Evaporative Resistance (Ref): 0.0018 kPa.m²/W (Note: The acceptance criteria here is for 'pressure', while the results are for 'resistance'. More information might be needed for a direct comparison, but usually, higher resistance is better for evaporative properties, and often 'permeability' is what a resistance value relates to. Assuming that the higher reported resistance value indicates good performance against a general evaporative resistance requirement.) | Pass (Based on general understanding that the device exhibits evaporative resistance.) |
| Lint and other particles generation in the dry state (ISO 9073-10:2004) | Critical area≤4.0, Less critical area≤4.0 | Material(Md): 2.2, Material(Uq): 2.3, Sleeve seam(Md): 2.2, Sleeve seam(Uq): 2.3 | Pass |
| Flammability (16 CFR Part 1610) | Class I | Not explicitly listed in a comparable table, but stated as "Pass" | Pass |
| Cytotoxicity (ISO 10993-5: 2009) | Non-Cytotoxic | No cytotoxic | Pass |
| Irritation (ISO 10993-10: 2010) | Non-Irritating | No irritating | Pass |
| Sensitization (ISO 10993-10: 2010) | Non-Sensitizing | No sensitizing | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the number of individual surgical gowns tested for each performance criterion. It provides results for "Lot#20210110", "Lot#20210112", and "Lot#20210114" for some tests, suggesting that multiple units from different manufacturing lots were tested. The number of samples per lot is not specified.
- Data Provenance: The tests were conducted as "Non-clinical tests" by the manufacturer, Hubei Wanli Protective Products Co.ltd. The country of origin of the data is implicitly China, where the manufacturer is located. The studies are by nature retrospective for the purpose of this 510(k) submission, meaning the tests were conducted prior to the submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as this is a non-clinical device performance study, not a study involving human interpretation of medical data where expert ground truth would be required. The "ground truth" here is established by standardized testing methodologies and their respective acceptance criteria.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as this is a non-clinical device performance study. Adjudication methods are typically used in clinical studies or studies involving expert review of medical images/data.
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:
This information is not applicable. This is a submission for a physical medical device (surgical gown) and does not involve AI assistance or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is a submission for a physical medical device (surgical gown) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's performance is established by validated standard test methods and their predetermined acceptance criteria (e.g., AATCC42-2017, AAMI/ANSI PB70:2012, ISO 10993-5, etc.). These standards define what constitutes acceptable performance for a surgical gown.
8. The sample size for the training set:
This information is not applicable. This is a non-clinical device performance study, not a machine learning study that would have a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
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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-USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 24, 2021
Hubei Wanli Protective Products Co. Ltd Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, Shanghai 200122 China
Re: K211509
Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 24, 2021 Received: September 24, 2021
Dear Eva Li:
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.
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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 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, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211509
Device Name Surgical Gown (Model: WLG1002-L3)
Indications for Use (Describe)
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/A AMI 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 non-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
A. Applicant
Hubei Wanli Protective Products Co.ltd. Address: Tangwan Street ,Xiliuhe Town,Xiantao ,Hubei,China
Contact Person: Andy Wen Tel: 0086-728-3227299 Fax: 0086-728-3223799 Email: sale01@hbwanli.com
Prepared Date: Oct 22nd , 2021 Submission
Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com
Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device
Trade Name: Surgical Gown Common Name: Surgical Gown Model: WLG1002-L3
- 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:
Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to
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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 non-sterile.
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. The Surgical 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 zone of the Surgical Gown are constructed from a blue PE SMS (spun-bond, melt-blown, spun-bond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical Gown is a single use, disposable medical device that will be provided of non-sterile packaging configurations.
F. Technological Characteristics Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | Hubei Wanli Protective ProductsCo.ltd. | Cardinal Health™ | — |
| 510(K) number | K211509 | K170762 | — |
| Model Name | Surgical Gown | Cardinal Health™ Non-ReinforcedSurgical Gown | — |
| Classification | Class II Device, FYA (21CFR878.4040) | Class II Device, FYA (21CFR878.4040) | Same |
| Intend use | Surgical Gown are intended to beworn by operating room personnelduring surgical procedures toprotect the surgical patient andoperating room personnel from thetransfer of microorganisms, bodyfluids and particulate material. Thissurgical gown meets therequirements of AAMI Level 3barrier protection for a surgicalgown per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protective appareland drapes intended for use inhealth care facilities (AAMI PB70). | Surgical Gown are intended to beworn by operating room personnelduring surgical procedures to protect the surgicalpatient and operating roompersonnel from the transfer ofmicroorganisms, body fluids andparticulate material. This surgicalgown meets the requirements ofAAMI Level 3 barrier protectionfor a surgical gown perANSI/AAMI PB70:2012 Liquidbarrier performance andclassification of protectiveapparel and drapes intended for | same |
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| Tangwan Street ,Xiliuhe Town,Xiantao ,Hubei,ChinaThe Surgical Gowns are single use,disposable medical devices;provided non-sterile. | use in health care facilities (AAMIPB70). The Surgical Gowns aresingle use, disposable medicaldevices; provided non-sterile. | ||
|---|---|---|---|
| MaterialComposition | Sleeve/body (polyethylene SMSNonwoven) | Polyolefin (Polypropylene)SMS nonwoven | Same |
| Color | Blue | Blue | same |
| Size | S,M,L,XL,XXL | M-S, M, L, XL, XXL | Similar |
| Sterility | Non-Sterile | Non-Sterile | same |
| Use | Single Use; Disposable | Single Use; Disposable | same |
| Weight persquare(g) | 45.9 g/m² | 31g/m² (1.32 oz/yd2) | Similar |
| Resistance toblood and liquidpenetration | Level 3 AAMI PB70 | Level 3 AAMI PB70 | same |
| Biocompatibility | Under the conditions of the study,the device extract was notcytotoxic. Under the conditions ofthe study, the non-polar and polardevice extracts were not found to bean irritant.Under conditions of the study, thenon-polar and polar device extractswere not found to be a sensitizer. | Under the conditions of the study,the device extract was notcytotoxic. Under the conditions ofthe study, the non-polar and polardevice extracts were not found tobe an irritant.Under conditions of the study,the non-polar and polar deviceextracts were not found to be asensitizer. | same |
| SterilizationModality | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
Table 2 performance test
| Performance | Lot#20210110 | Lot#20210112 | Lot#20210114 | |
|---|---|---|---|---|
| Impact penetrationAATCC42-2017(≤1.0g) | Front | 0.2 | 0.1 | 0.2 |
| Back | 0.2 | 0.2 | 0.1 | |
| Sleeve seams | 0.2 | 0.1 | 0.2 | |
| Side seams | 0.2 | 0.2 | 0.1 | |
| Belt Seam | 0.1 | 0.1 | 0.1 | |
| hydrostatic pressureAATCC 127-2018(≥50 cmH2o) | Front | 74.10 | 73.08 | 73.15 |
| Back | 70.19 | 71.66 | 71.53 | |
| Sleeve seams | 70.95 | 70.34 | 70.89 | |
| Side seams | 73.99 | 75.72 | 77.10 | |
| Belt Seam | 56.10 | 56.62 | 58.98 |
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| Tangwan Street, Xinlune Town, Xiantao, Hubei, China | |||
|---|---|---|---|
| Testing item | Shoulder | Armhole | Sleeve |
| Seam strength(mean) | 71.8N | 66.0N | 77.0N |
| Testing Item | Mean |
|---|---|
| Tensile strength, MD* | 27.8 IBS |
| Tensile strength, CD* | 19.1 IBS |
| Tear strength, MD* | 10.7 IBS |
| Tear strength, CD* | 6.24 IBS |
| Weight per Unit Area | 45.9g/m2 |
| Evaporative Resistance Of Clothing Materials | Mean |
|---|---|
| Evaporative Resistance (Ret) | 0.0052 kPa.m²/W |
| Intrinsic Evaporative Resistance (Ref) | 0.0018 kPa.m²/W |
| Lint | And | Other | ParticlesGeneration In The Dry State | A:Face | B: Face |
|---|---|---|---|---|---|
| Material(Md) | 2.2 | 2.4 | |||
| Material(Uq) | 2.3 | 2.5 | |||
| Sleeve seam(Md) | 2.2 | 2.4 | |||
| Sleeve seam(Uq) | 2.3 | 2.4 |
Table3 Biocompatibility Comparison
| Item | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|
| Cytotoxicity | Under the conditions ofthe study, the device isnon-cytotoxic. | Non-Cytotoxic | No cytotoxic |
| Irritation | Under the conditions ofthe study, the device isnon-irritating. | Non-Irritating | No irritating |
| Sensitization | Under the conditions ofthe study, the device isnon-sensitizing | Non-Sensitizing | No sensitizing |
G. Summary of Non-Clinical Performance Testing
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 A Cytotoxicity
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And
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Skin Sensitization
A CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles;
ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics A (Grab Test);
-
A ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by TrapezoidProcedure;
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Appareland A Drapes Intended For Use In Health Care Facilities. -
A ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
-
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
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| AATCC42-2017 | Water Resistance:Impact penetration | ≤1.0g | Pass |
| AATCC 127-2018 | Water Resistance:hydrostatic pressure | ≥50 cmH2O | Pass |
| ASTM D1683/D1683M-2017(R2018) | Seam strength(sleeve seam) | ≥20N(4.5lbf) | Pass |
| ASTM D5587-15(2019),Tensile Testing Machine,CR | Tensile strength | ≥20N(4.5lbf) | Pass |
| ASTM D5034-09(2017), 1-in Grab Test, TensileTesting Machine, CRE | Tear strength | ≥20N | Pass |
| ASTM F 1868-2017,Procedure Part B | Evaporative Resistance OfClothing Materials | ≥30cmH2O (0.00294Kpa) | Pass |
| ISO 9073-10:2004 | Lint and other particlesgeneration in the drystate(material) | Critical area≤4.0Less critical area≤4.0 | Pass |
| 16 CFR Part 1610 | Flammability | Class I | Pass |
H. Summary of Clinical Performance Test
No clinical study is included in this submission.
I. Conclusion
The conclusions drawn fromthe nonclinical tests performed demonstrate thatthe subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Cardinal Health™ Non-Reinforced Surgical Gown 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.