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

K221637 · Allmed Medical (Hubei) Protective Products Co., Ltd. · FYA · Sep 29, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221637
• Device Name: Surgical Gown (Sterile); Surgical Gown (Non-sterile)
• Applicant: Allmed Medical (Hubei) Protective Products Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Sep 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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 Story

Single-use, disposable, non-reinforced surgical gown; constructed of SMS (spunbond-meltblown-spunbond) nonwoven polypropylene/polyester material. Available in six sizes (S-XXXL) and blue color. Provided in sterile or non-sterile formats; non-sterile versions require ethylene oxide (EtO) sterilization by re-packagers. Worn by operating room personnel to protect patient and staff from fluid/particulate transfer. Performance verified via bench testing against AAMI Level 3 standards; provides physical barrier protection during surgery.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via AAMI/ANSI PB70:2012, AATCC 127-2018, AATCC 42-2017, ASTM D5034-09, ASTM D5587-15, ASTM D1683-17, ASTM F1868-17, ISO 9073-10-2003, and 16 CFR 1610. Biocompatibility confirmed per ISO 10993-5, -7, and -10.

Technological Characteristics

Materials: SMS (spunbond-meltblown-spunbond) polypropylene/polyester nonwoven. Form factor: Disposable gown, sizes S-XXXL. Barrier performance: AAMI Level 3. Sterilization: Ethylene Oxide (ISO 11135-1). Standards: ASTM D5587-15 (tearing), ASTM D5034-09 (breaking), ASTM D1683-17 (seam), ASTM F1868-17 (evaporative resistance), ISO 9073-10-2003 (linting), AATCC 127/42 (water resistance).

Indications for Use

Indicated for operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, and particulate material. Meets AAMI Level 3 liquid barrier performance requirements.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Surgical Gown (Sterile); Surgical Gown (Non-sterile) (K202706)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K221637

#### Device Name

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

#### Indications for Use (Describe)

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.

| 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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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: [phone] Fax: [phone] Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] 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)

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# 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:

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.

#### F. Comparison Tables of Proposed and Predicate Devices

| Item | Proposed Device | Predicate Device | Result |
|--------------|---------------------------------------------------------|---------------------------------------------------------|--------|
| 510K # | K221637 | K202706 | - |
| Manufacturer | Allmed Medical (Hubei) Protective<br>Products Co., Ltd | B.J.ZH.F.PANTHER MEDICAL<br>EQUIPMENT CO., LTD. | - |
| Product Name | Surgical Gown (Sterile); Surgical Gown<br>(Non-sterile) | Surgical Gown (Sterile); Surgical<br>Gown (Non-sterile) | Same |
| Level | Level 3 | Level 3 | Same |

#### Table 1 General Comparison of Proposed and Predicate Devices

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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 be<br>worn by operating room personnel<br>during surgical procedure to protect both<br>the surgical patient and the operating<br>room personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material. Per ANSI/AAMI<br>PB70:2012 Liquid barrier performance<br>and classification of protective apparel<br>and drapes intended for use in health<br>care facilities, the surgical gowns met the<br>requirements for Level 3 classification.<br><br>Non-sterile gowns are to be sold to<br>re-packager/re-labeler establishments for<br>ethylene oxide (EtO) sterilization<br>according to ISO 11135-1 prior to<br>marketing to the end users and sterile<br>surgical gowns are to be sold directly to<br>the end users after EtO sterilization<br>validation to ISO 11135-1. | Surgical gowns are intended to be<br>worn by operating room personnel<br>during surgical procedure to protect<br>both the surgical patient and the<br>operating room personnel from<br>transfer of microorganisms, body<br>fluids, and particulate material. Per<br>ANSI/AAMI PB70:2012 Liquid<br>barrier performance and classification<br>of protective apparel and drapes<br>intended for use in health care<br>facilities, the surgical gowns met the<br>requirements for Level 3<br>classification. | 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 138.64N<br>CD Mean 75.10N | >20N | Similar |
| Tearing strength | MD Mean 34.39N<br>CD Mean 18.06N | >20N | Similar |
| Seam strength | Mean 57.56 N | Not available on Predicate Device's<br>510K Summary | Similar |

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

| Evaporative<br>Resistance | $0.00315kPa \cdot m^2/W$ | Not available on Predicate Device's<br>510K Summary | Similar |
|-----------------------------|-------------------------------------------------|-----------------------------------------------------|---------|
| Linting | $Log_{10}$ Mean 2.7 | $Log_{10}$ <4 | Similar |
| Material | SMS polypropylene<br>Nonwoven+Polyester | SMS polypropylene<br>Nonwoven+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 Oxide<br>Residuals | EO residual<4mg/piece<br>ECH residual<9mg/piece | Not available on Predicate Device's<br>510K 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

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

# Table 3 Summary of Performance and Biocompatibility Testing

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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,

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# 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.