(443 days)
The Sterile Level 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
The Sterile Level 3 Surgical Gown is a Class II medical device under the FDA product code of FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Sterile Level 3 Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Sterile Level 3 Surgical Gown is 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. The proposed devices are single use and EtO sterilized. The Sterile Level 3 Surgical Gowns are available in six sizes, including S, M, L, XXL and XXXL. The belt ties are integrated into the body. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification. The Sterile Level 3 Surgical Gown is provided as blue color. The Sterile Level 3 Surgical Gown is made of 50 Gsm PP (SMMS nonwoven polypropylene).
The provided text describes the acceptance criteria and study results for a Sterile Level 3 Surgical Gown. This is not an AI/ML powered medical device, but rather a textile product. As such, the requested information pertaining to AI/ML device studies (such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment for AI/ML) is not applicable or present in this engineering report.
The report details non-clinical performance testing for the physical properties and barrier performance of the surgical gown.
Here's a breakdown of the requested information based on the provided document for this medical device (a surgical gown):
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| 16 CFR 1610 | Flammability of Textiles | Class 1 | Class 1 |
| ASTM D5034-09(2017) | Tensile Strength | ≥7 lbf | Warp: 20.59 lbf, Weft: 30.48 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | RIGHT ARMHOLE SEAM STRENGTH / SLIPPAGE: 8.1 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | LEFT ARMHOLE SEAM STRENGTH / SLIPPAGE: 9.8 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | RIGHT SHOULDER SEAM STRENGTH / SLIPPAGE: 14.1 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | LEFT SHOULDER SEAM STRENGTH / SLIPPAGE: 14.7 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | RIGHT SLEEVE SEAM STRENGTH / SLIPPAGE: 9.0 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength (Garment) | ≥7 lbf | LEFT SLEEVE SEAM STRENGTH / SLIPPAGE: 9.1 lbf |
| ASTM D5587-15 (2019) | Tear Strength | ≥ 2.3 lbf | Warp: 5.817 lbf, Weft: 8.958 lbf |
| ISO 9073-10 | Evaluation of Particles Release | log10 ≤4 | Suitable according to ≤ 4 criteria |
| AATCC 127:2017 Option 2 | Water Resistance: Impact Penetration Test | ≥ 50 cm | 53.7 - 65.8 cm. LEVEL 3. |
| AATCC 42:2007 | Impact Penetration Test | no more than 1.0 grams (g) | Max 0.08. LEVEL 3 |
| ISO 10993-7 | EO Residue Test | 10µg/cm² | Not detected. |
| ISO 10993-5 | Cytotoxicity | Not Cytotoxic | Not Cytotoxic |
| ISO 10993-10 | Sensitization | Not Sensitive | Not Sensitive |
| ISO 10993-10 | Irritation | Not Irritant | Not Irritant |
| ASTM F88/F88M | Seal Strength of Flexible Barrier Materials | Package Seal integrity must be intact. | Passed |
| ASTM F1929:2015 | Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | No leakage observe | Passed |
| ASTM D3776 / D3776M - 20 | Mass Per Unit Area (Weight) of Fabric | - | 50 GSM |
Regarding AI/ML specific information (not applicable to this product):
- Sample sizes used for the test set and the data provenance: Not applicable. This is a physical product (surgical gown), not an AI/ML device. Tests were conducted on material samples of the gown. No information on the number of gowns or samples tested is provided beyond the aggregated results. The data provenance is implied to be from the manufacturer's testing, without specific country of origin mentioned for the raw test data. The tests are prospective in nature, as they are part of the premarket submission for a new device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties is established by standardized testing according to specified ASTM/ISO norms, not by expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus among human readers for AI/ML device studies.
- 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 a physical product, not an AI/ML system assisting human readers. The document explicitly states "Clinical Performance Testing is not applicable to the subject device."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical product, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective measurement based on established ASTM and ISO standards for material properties, fluid barrier performance, flammability, biocompatibility, and packaging integrity.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the full name written in a sans-serif font. The full name is "U.S. FOOD & DRUG ADMINISTRATION".
July 22, 2022
Barco Tekstil Sanayi ve Ticaret A.S. % Mehmet Örmeci Consultant MEDCER Uluslararasi Medikal Belgelendirme A.S. Taspinar Mah. 2800 Cad. A-2 Apt. No:6 B/49 Ankara, Golbasi 06830 Turkey
Re: K211399
Trade/Device Name: Sterile Level 3 Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FYA Dated: June 21, 2022 Received: June 21, 2022
Dear Mehmet Örmeci:
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.
{1}------------------------------------------------
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.
BiFeng Oian, 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 Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K211399
Device Name Sterile Level 3 Surgical Gown
Indications for Use (Describe)
The Sterile Level 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSVAAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for BARCO. The logo is white text on a gray background. The A in BARCO is replaced with a yellow triangle. Below the word BARCO is the text "SOLUTIONS FOR TECHNICAL SPORTS WEAR".
510(k) Summary K211399
510(k) Summary
| 510(k) Submitter | BARCO TEKSTIL SANAYI VE TICARET A.S. | |
|---|---|---|
| 510(k) Submitter | Muratbey Mahallesi Karatoprak Caddesi No. 17Catalca Istanbul, TR 34540 | |
| 510(k) Submitter Telephone No | Phone: +90 212 867 49 00Fax: +90 212 494 32 34 | |
| Primary CorrespondentContact Information | Mehmet Fatih Ormeci (Consultant)+90-532-397-3043mformeci@gmail.comFax: +90 212 494 32 34 | |
| Summary Preparation Date | 07/21/2022 |
| Trade Or ProprietaryName | Sterile Level 3 Surgical Gown |
|---|---|
| Common Name | Surgical Gown |
| Classification Name | Gown, Surgical |
| Regulation Number | 21 CFR 878.4040 |
| Product Code | FYA |
| Subject DeviceName | Subject Device510k No | Predicate Device510k No | Predicate Device Manufacturer |
|---|---|---|---|
| Sterile Level 3Surgical Gown | K211399 | K202706 | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD.Floor 3, Building 1, 28 Huoju Street, ChangpingScience and Technology Park, Changping District,102200 Beijing, China |
Device Description
Sterile Level 3 Surgical Gown
The Sterile Level 3 Surgical Gown is a Class II medical device under the FDA product code of FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Sterile Level 3 Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Sterile Level 3 Surgical Gown is 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. The proposed devices are single use and EtO sterilized. The Sterile Level 3 Surgical Gowns are available in six sizes, including S, M, L, XXL and XXXL. The belt ties are integrated into the body. Per ANSI/AAMI PB70:2012 Liquid barrier
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for BARCO, a company that provides solutions for technical sportswear. The logo is displayed in white text on a gray background. The "A" in BARCO is replaced with a yellow triangle.
performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices meet the requirements for Level 3 classification. The Sterile Level 3 Surgical Gown is provided as blue color. The Sterile Level 3 Surgical Gown is made of 50 Gsm PP (SMMS nonwoven polypropylene).
| Model Name | Size | Reference No | Colour | Level | Fabric | Sterilization | FDACode |
|---|---|---|---|---|---|---|---|
| Sterile Level 3Surgical Gown | S | GS101-L3U-50S-S | Blue | 3 | 50 Gsm PP(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3Surgical Gown | M | GS101-L3U-50S-M | Blue | 3 | 50 Gsm PP(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3Surgical Gown | L | GS101-L3U-50S-L | Blue | 3 | 50 Gsm PP(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3Surgical Gown | XL | GS101-L3U-50S-XL | Blue | 3 | 50 Gsm PP(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3Surgical Gown | XXL | GS101-L3U-50S-XXL | Blue | 3 | 50 Gsm PP(Nonwoven Polypropylene) | Sterile | FYA |
| Sterile Level 3Surgical Gown | XXXL | GS101-L3U-50S-XXXL | Blue | 3 | 50 Gsm PP(Nonwoven Polypropylene) | Sterile | FYA |
Indications For Use
Sterile Level 3 Surgical Gown
The Sterile Level 3 Surgical Gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gowns met the requirements for Level 3 classification.
Technological Characteristics
Shown below is the technological characteristics comparison of the subject device and the predicate device.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for BARCO, a company that provides solutions for technical sportswear. The logo is set against a gray background. The word "BARCO" is written in large, white letters, with a yellow triangle taking the place of the letter "A". Below the company name, the text "SOLUTIONS FOR TECHNICAL SPORTS WEAR" is written in a smaller font.
510(k) Summary
Surgical Gown
| Item | Subject DeviceSterile Level 3 Surgical Gown K211399 | Predicate Device K202706 | Remark |
|---|---|---|---|
| Product Code | FYA | FYA | Same |
| Regulation No. | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Class | II | II | Same |
| IntendedUse/Indications forUse | The Sterile Level 3 Surgical Gown isintended to be worn by operating roompersonnel during surgical procedure toprotect both the surgical patient and theoperating room personnel from transfer ofmicroorganisms, body fluids, andparticulate material. Per ANSI/AAMIPB70:2012 Liquid barrier performance andclassification of protective apparel anddrapes intended for use in health carefacilities, the surgical gowns met therequirements for Level 3 classification. | Surgical gowns are intended to be worn byoperating room personnel during surgicalprocedure to protect both the surgicalpatient and the operating room personnelfrom transfer of microorganisms, bodyfluids, and particulate material. PerANSI/AAMI PB70:2012 Liquid barrierperformance and classification ofprotective apparel and drapes intended foruse in health care facilities, the surgicalgowns met the requirements for Level 3classification. | Same |
| Style | Non-reinforced | Non-reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same |
| Weight per square (g) | 50 Gsm | 55g/m2 | Different1.1. |
| Size | S, M, L, XL, XXL, XXXL | S, M, L, XL, XXL, XXXL | Same |
| Flammability | Class I | Class I | Same |
| Hydrostatic pressure | >50 cm | >50 cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Breaking strength | >20N | >20N | Same |
| Tearing strength | >20N | >20N | Same |
| Linting | Log10<4 | Log10<4 | Same |
| Material | SMMS nonwoven polypropylene | SMS polypropylene nonwoven + PE | Different1.2 |
| Level | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |
| Biocompatibility | |||
| Cytotoxicity | According to ISO 10993-5: 2009, the testmaterial demonstrated no cytotoxic effectunder the condition of this study. | No Cytotoxicity | Same |
| Irritation | The test result showed that the irritantresponse of the test article extract wascategorized as negligible under the testcondition. Complies with ISO 10993-10:2010. | No Irritation | Same |
| Sensitization | Under the conditions of this study, the testarticle extract showed no significantevidence of causing skin sensitization in theguinea pig. Complies with ISO 10993-10:2010. | No Sensitization | Same |
| Sterile | Sterile | Sterile/Non-sterile | Same |
Discussion
Sterile Level 3 Surgical Gown
The indications for use statement for the subject device is identical to the predicate device. There are no technological differences between the predicate and subject devices except for the following:
- . Different 1.1: The subject device is 50 gsm and the predicate device is 55 gsm. These slight differences have no adverse effect on clinical safety and performance. All of the subject device are tested in accordance with related standards given in Non-Clinical Testing Section of this summary. The requirements of the standards are met.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for BARCO, a company that provides solutions for technical sportswear. The logo is displayed in a sans-serif font, with the "A" in BARCO replaced by a yellow triangle. Below the company name is the text "SOLUTIONS FOR TECHNICAL SPORTS WEAR" in a smaller font.
- Different 1.2: Subject device is made from SMS nonwoven polypropylene and the predicate device is made from SMS nonwoven polypropylene + PE. The subject device biocompatibility results and performance results demonstrate product safety. These slight differences have no adverse effect on clinical safety and performance. All of the subject device are tested in accordance with related standards given in Non-Clinical Testing Section of this summary. The requirements of the standards are met.
The intended use, principle of operation, materilization information for the subject device are the
same as the predicate device. The differences between the subject device do not raise any
new or different questions of safety or effectiveness.
Non-Clinical Performance Testing
Sterile Level 3 Surgical Gown
Non clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed subject device complies with the following standards:
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| 16 CFR 1610 | Flammability of Textiles | Class 1 | Class 1 |
| ASTM D5034-09(2017) | Tensile Strength | ≥7 lbf | Warp:20,59 lbf, Weft: 30,48lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength(Garment) | ≥7 lbf | RIGHT ARMHOLE SEAMSTRENGTH / SLIPPAGE: 8.1 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength(Garment) | ≥7 lbf | LEFT ARMHOLE SEAMSTRENGTH / SLIPPAGE: 9.8 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength(Garment) | ≥7 lbf | RIGHT SHOULDER SEAMSTRENGTH / SLIPPAGE: 14.1lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength(Garment) | ≥7 lbf | LEFT SHOULDER SEAMSTRENGTH / SLIPPAGE: 14.7lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength(Garment) | ≥7 lbf | RIGHT SLEEVE SEAMSTRENGTH / SLIPPAGE: 9.0 lbf |
| ASTM D1683/D1683M-17(2018) | Seam Strength(Garment) | ≥7 lbf | LEFT SLEEVE SEAM STRENGTH/ SLIPPAGE: 9.1 lbf |
| ASTM D5587-15 (2019) | Tear Strength | ≥ 2.3 lbf | Warp:5,817 lbf, Weft: 8,958lbf |
| ISO 9073-10 | EVALUATION OFPARTICLES RELEASE | log 10 ≤4 | It is suitable according to ≤ 4criteria. |
| AATCC 127:2017Option 2 | Water Resistance:Impact Penetration Test | ≥ 50 cm | 53,7 - 65,8 cm. LEVEL 3. |
| AATCC 42:2007 | Impact Penetration Test | no more than 1.0grams (g) | Max 0.08. LEVEL 3 |
{7}------------------------------------------------
| 510(k) SummarySurgical Gown | 07/21/202Page 5 / 5 | |||
|---|---|---|---|---|
| ISO 10993-7: | EO Residue Test | 10µg/cm² | Not detected. | |
| ISO 10993-5 | Cytotoxicity | Not Cytotoxic | Not Cytotoxic | |
| ISO 10993-10 | Sensitization | Not Sensitive | Not Sensitive | |
| ISO 10993-10 | Irritation | Not Irritant | Not Irritant | |
| ASTM F88/F88M | Seal Strength of FlexibleBarrier Materials | Package Sealintegritymust beintact. | Passed | |
| ASTM F1929:2015 | Detecting Seal Leaks inPorous MedicalPackaging by DyePenetration | No leakageobserve | Passed | |
| ASTM D3776 / D3776M - 20 | Mass Per Unit Area(Weight) of Fabric | - | 50 GSM |
Clinical Performance Testing
The clinical performance testing is not applicable to the subject device.
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device.
§ 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.