The proposed surgical gowns are 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.

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 the end users after EtO sterilization validation to ISO 11135-1.

Device Description

The proposed surgical gowns 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. The proposed devices are single use, disposable medical devices and can be provided in sterile two types. Both the sterile and non-sterile surgical gowns are blue colored and available in six sizes, including S, M. L, XL, XXL and XXXL. For non-sterile surgical gowns, they shall be sterilized by EO prior to use.

The proposed surgical gowns are constructed of a SMS nonwoven material (spunbond +meltblown + spunbond nonwovens) and has been tested according to ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities and meets AAMI Level 3. It is a kind of non-reinforced surgical gown.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Surgical Gown device (K221637), based on the provided document:

Acceptance Criteria and Device Performance

Testing Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Performance Testing
Hydrostatic Pressure (AATCC 127-2018)	To measure the resistance of a fabric to the penetration of water under hydrostatic pressure	≥50cm H2O	Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. All parts of test specimen met the Level 3 requirements.
Water Resistance (AATCC 42-2017)	To verify the impact penetration of the device.	≤1.0g	Passed. 3 non-consecutive lots tested, using a sample size of 32/lot. All parts of test specimen met the Level 3 requirements.
Tearing Strength (ASTM D5587-15 (2019))	To determine the tearing strength of the device.	≥10N	Passed. Sample size of 10 pcs. MD Mean: 34.39N, CD Mean: 18.06N.
Breaking Strength (ASTM D5034-09 (2017))	To determine the breaking strength and elongation of the device.	≥30N	Passed. Sample size of 10 pcs. MD Mean: 138.64N, CD Mean: 75.10N.
Seam Strength (ASTM D1683/D1683M-17(2018))	To measure the sewn seam strength in surgical gown by applying a force perpendicular to the sewn seams	≥30N	Passed. Sample size of 10 pcs. Mean 57.56 N.
Evaporative Resistance (ASTM F1868-17)	To measure the evaporative resistance under steady-state conditions of fabrics of the device.	≤1.0kPa·m²/W	Passed. Sample size of 3pcs. 0.00315 kPa • m²/W.
Lint and other particles generation in the dry state (ISO 9073-10-2003)	To measure the linting of non-woven in the dry state.	Coefficient of linting Log₁₀≤4.0	Passed. Sample size of 10pcs. Log₁₀ Mean: 2.7.
Flammability (16 CFR 1610)	To determine the flammability of textiles for the surgical gowns.	Class I	Passed. Sample size of 5 pcs. All samples are Class I.
Biocompatibility Testing
Cytotoxicity	Assess the potential risk of cytotoxicity of surgical gown material	Non-cytotoxic	Passed. Under the condition of this study, the device has no potential toxicity.
Irritation	Assess the potential risk of irritation of surgical gown material	Negligibly irritating	Passed. Under the condition of this study, the device is negligibly irritating.
Sensitization	Assess the potential risk of sensitization of surgical gown material	Non-sensitizing	Passed. Under the conditions of the study, the device is non-sensitizing.
Ethylene Oxide Residuals	Verify low levels of sterilant residuals	EO residual < 4mg/piece, ECH < 9mg/piece	Passed. The EO/ECH residuals shown in test report are far below the criteria.

Study Information

The provided document describes non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a study involving human subjects or artificial intelligence.

Sample size used for the test set and the data provenance:
- Hydrostatic Pressure: 3 non-consecutive lots, with a sample size of 32 per lot.
- Water Resistance: 3 non-consecutive lots, with a sample size of 32 per lot.
- Tearing Strength: 10 pieces.
- Breaking Strength: 10 pieces.
- Seam Strength: 10 pieces.
- Evaporative Resistance: 3 pieces.
- Lint and other particles generation: 10 pieces.
- Flammability: 5 pieces.
- Biocompatibility (Cytotoxicity, Irritation, Sensitization): Not explicitly stated, but the tests were performed "Under the condition of this study" or "Under the conditions of the study."
- Ethylene Oxide Residuals: Not explicitly stated, but "shown in test report."
- Data Provenance: The document does not specify the country of origin of the data beyond the manufacturer being in Hubei, China. The studies are non-clinical, likely laboratory tests, not retrospective or prospective patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This involves non-clinical laboratory testing against established physical and chemical standards, not expert evaluation of medical images or conditions where a "ground truth" established by experts would be relevant.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a study involving human reviewers or interpretation that would require an adjudication method. The results are based on objective measurements against specified standards.
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 submission for a surgical gown, not an AI-assisted diagnostic or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device (surgical gown), not an algorithm.
The type of ground truth used: The "ground truth" in this context is the predefined acceptance criteria set forth by established international and national standards (e.g., ANSI/AAMI PB70:2012, ASTM, ISO, AATCC, CFR standards). The device's performance is measured against these objective criteria.
The sample size for the training set: Not applicable. This is not a machine learning device that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

{0}------------------------------------------------

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 and Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 29, 2022

Allmed Medical (Hubei) Protective Products Co., Ltd % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K221637

Trade/Device Name: Surgical Gown (Sterile); Surgical Gown (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 2, 2022 Received: September 2, 2022

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.

{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 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221637

Device Name

Surgical Gown (Sterile); Surgical Gown (Non-sterile)

Indications for Use (Describe)

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}------------------------------------------------

Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China

510(K) Summary

K221637

(As requirement by 21 CFR 807.92)

Date prepared: 29th, September, 2022

A. Applicant:

Name: Allmed Medical (Hubei) Protective Products Co., Ltd Address: No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China Contact Person: Vince Tian Title: General Manager of Quality Tel: 86 717 4215906 Fax: 86 717 4215989 Email: vince@allmed.cn

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: Surgical Gown (Sterile); Surgical Gown (Non-sterile) Common Name: Surgical Gown Model: S, M, L, XL, XXL and XXXL

Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital

C. Predicate device:

K202706 B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., LTD. Trade Name: Surgical Gown (Sterile); Surgical Gown (Non-sterile)

{4}------------------------------------------------

Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China

Common Name: Surgical Gown

Regulatory Information Classification Name: Gown, Surgical Classification: II Product code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital

D. Indications for use of the device:

The surgical gowns are 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.

Non-sterile gowns are to be sold to re-packager/re-labeler establishments for ethylene oxide (EiO) sterilization according to ISO 11135-1 prior to marketing to the end users and sterile surgical gowns are to be sold directly to the end users after EtO sterilization validation to ISO 11135-1.

E. Device Description:

F. Comparison Tables of Proposed and Predicate Devices

Item	Proposed Device	Predicate Device	Result
510K #	K221637	K202706	-
Manufacturer	Allmed Medical (Hubei) ProtectiveProducts Co., Ltd	B.J.ZH.F.PANTHER MEDICALEQUIPMENT CO., LTD.	-
Product Name	Surgical Gown (Sterile); Surgical Gown(Non-sterile)	Surgical Gown (Sterile); SurgicalGown (Non-sterile)	Same
Level	Level 3	Level 3	Same

Table 1 General Comparison of Proposed and Predicate Devices

{5}------------------------------------------------

Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China

Product Code	FYA	FYA	Same
Regulation Number	21 CFR 878.4040	21 CFR 878.4040	Same
Indications for use	The surgical gowns are intended to beworn by operating room personnelduring surgical procedure to protect boththe surgical patient and the operatingroom personnel from transfer ofmicroorganisms, body fluids, andparticulate material. Per ANSI/AAMIPB70:2012 Liquid barrier performanceand classification of protective appareland drapes intended for use in healthcare facilities, the surgical gowns met therequirements for Level 3 classification.Non-sterile gowns are to be sold tore-packager/re-labeler establishments forethylene oxide (EtO) sterilizationaccording to ISO 11135-1 prior tomarketing to the end users and sterilesurgical gowns are to be sold directly tothe end users after EtO sterilizationvalidation to ISO 11135-1.	Surgical gowns are intended to beworn by operating room personnelduring surgical procedure to protectboth the surgical patient and theoperating room personnel fromtransfer of microorganisms, bodyfluids, and particulate material. PerANSI/AAMI PB70:2012 Liquidbarrier performance and classificationof protective apparel and drapesintended for use in health carefacilities, the surgical gowns met therequirements for Level 3classification.	Same
Style	Non-reinforced	Non-reinforced	Same
Durability	Disposable	Disposable	Same
Color	Blue	Blue	Same
Labeling	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	Same

Table 2 Performance Comparison of Proposed and Predicate Devices

Item	Proposed Device	Predicate Device K202706	Result
Weight per square (g)	$41\pm3g/m^2$	$55g/m^2$	Similar
Size	S, M, L, XL, XXL, XXXL	S, M, L, XL, XXL, XXXL	Same
Flammability	Class I	Class I	Same
Hydrostatic pressure	$\ge50$ cm	$\ge50$ cm	Same
Water impact	$\le1.0g$	$\le1.0g$	Same
Breaking strength	MD Mean 138.64NCD Mean 75.10N	>20N	Similar
Tearing strength	MD Mean 34.39NCD Mean 18.06N	>20N	Similar
Seam strength	Mean 57.56 N	Not available on Predicate Device's510K Summary	Similar

{6}------------------------------------------------

Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China

EvaporativeResistance	$0.00315kPa \cdot m^2/W$	Not available on Predicate Device's510K Summary	Similar
Linting	$Log_{10}$ Mean 2.7	$Log_{10}$ <4	Similar
Material	SMS polypropyleneNonwoven+Polyester	SMS polypropyleneNonwoven+polyester	Same
Biocompatibility
Cytotoxicity	No cytotxicity	No cytotxicity	Same
Irritation	No Irritation	No Irritation	Same
Sensitization	No sensitization	No sensitization	Same
Sterile	Sterile/Non-sterile	Sterile/Non-sterile	Same
Sterilization method	EO sterilization	EO sterilization	Same
Ethylene OxideResiduals	EO residual<4mg/pieceECH residual<9mg/piece	Not available on Predicate Device's510K Summary	Similar

Analysis:

The subject surgical gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, material composition. The tearing strength, breaking strength and linting are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ISO 9073-10-2003 respectively, and met the requirements of the standard.

Under the conditions of each study, the subject surgical gowns (sterile and non-sterile) are non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.

Evaporative Resistance: Although the data of evaporative resistance of the predicate device is not publicity available, the proposed device has been tested for the performance according to ASTM F1868-17 and the result as shown is far below the limit, i.e. 1.0 kPa · m2/W, as required by the standard, which can prove the safety and effectiveness of the proposed surgical gown.

Sterilization: Both the proposed and the predicate devices have same sterilization for sterile products, i.e. EO sterilization. Although the concrete date of EO/ECH residual of the predicate device is not publicity available, EO/ECH residual of the proposed device have been tested according to ISO 10993-7 and meet the residual requirements of the standard. No safety or effectiveness concern will be raised.

G. Summary of Non-Clinical Testing

Non-clinical tests were conducted to verify that the proposed device met all design specification. The test results demonstrated that the proposed device complies with the following standards and ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.

A ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
A ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

{7}------------------------------------------------

Allmed Medical (Hubei) Protective Products Co., Ltd

No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China

A ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation And Skin Sensitization
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of protective Apparel and Drapes Intended For Use In Health Care Facilities
AATCC 127-2018, Water Resistance: Hydrostatic Pressure Test
AATCC 42-2017, Water Penetration Resistance: Impact Penetration Test
A ASTM D5034-09 (2017), Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test)
ASTM D5587-15 (2019), Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure;
ASTM D1683/D1683M-17(2018) Standard Test Method for Failure in Seams of Woven Fabrics
ASTM F1868-17 Standard Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate
ISO 9073-10-2003 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state
16 CFR 1610, Standard for the Flammability of Clothing Textiles
ASTMF88/F88M:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
ASTM F1886/F1886-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

Testing Methodology	Purpose	Acceptance Criteria	Result
Performance Testing
Hydrostatic PressureAATCC 127-2018	To measure the resistance ofa fabric to the penetration ofwater under hydrostaticpressure	≥50cm H2O	Passed3 non-consecutive lotstested, using a samplesize of 32/lot.All parts of testspecimen met the level3 requirements.
Water ResistanceAATCC 42-2017	To verify the impactpenetration of the device.	≤1.0g	Passed3 non-consecutive lotstested, using a samplesize of 32/lot.All parts of testspecimen met the level3 requirements.
Tearing StrengthASTM D5587-15 (2019)	To determine the tearingstrength of the device.	≥10N	PassedSample size of 10 pcsMD Mean: 34.39NCD Mean: 18.06N

Breaking StrengthASTM D5034-09 (2017)	To determine the breakingstrength and elongation ofthe device.	≥30N	PassedSample size of 10 pcsMD Mean: 138.64NCD Mean: 75.10N
Seam StrengthASTMD1683/D1683M-17(2018)	To measure the sewn seamstrength in surgical gown byapplying a forceperpendicular to the sewnseams	≥30N	PassedSample size of 10 pcsMean 57.56 N
Evaporative ResistanceASTM F1868-17	To measure the evaporativeresistance under steady-stateconditions of fabrics of thedevice.	≤1.0kPa·m²/W	PassedSample size of 3pcs0.00315 kPa • m²/W
Lint and other particlesgeneration in the dry stateISO 9073-10-2003	To measure the linting ofnon-woven in the dry state.	Coefficient of lintingLog₁₀≤4.0	PassedSample size of 10pcsLog₁₀ Mean: 2.7
Flammability16 CFR 1610	To determine theflammability of textiles forthe surgical gowns.	Class I	PassedSample size of 5 pcsAll samples are Class I
Biocompatibility Testing
Cytotoxicity	Assess the potential risk ofcytotoxicity of surgicalgown material	Non-cytotoxic	PassedUnder the condition ofthis study, the devicehas no potentialtoxicity.
Irritation	Assess the potential risk ofirritation of surgical gownmaterial	Negligibly irritating	PassedUnder the condition ofthis study, the device isnegligibly irritating.
Sensitization	Assess the potential risk ofsensitization of surgicalgown material	Non-sensitizing	PassedUnder the conditionsof the study, the deviceis non-sensitizing
Ethylene Oxide Residuals	Verify low levels of sterilantresiduals	EO residual < 4mg/pieceECH < 9mg/piece	PassedThe EO/ECH residualsshown in test reportare far below thecriteria

Table 3 Summary of Performance and Biocompatibility Testing

{8}------------------------------------------------

Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission,

{9}------------------------------------------------

Allmed Medical (Hubei) Protective Products Co., Ltd No.29 Dong Hu Road, Majiadian Town, Zhijiang City, Hubei, China

the subject surgical gown is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202706.

Regulation Number and Section

§ 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.