Surgical gowns 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.

Device Description

The 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. It is made of soft, air permeable SMS non-woven fabric.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding a Surgical Gown (K141467). It reports the device's technical specifications and compares them to predicate devices to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices, where the proposed device's performance is expected to be similar or better than that of the predicates, specifically meeting or exceeding their reported values or "Met acceptance criteria."

Specification	Acceptance Criteria (Predicate)	Reported Device Performance (Proposed)
Material	SMS	SMS
Weight per square (g)	Predicate 1: 45; Predicate 2: 50	45
Durability	Disposable	Disposable
Color	Predicate 1: Blue; Predicate 2: Various	Blue
Reinforced area	Predicate 1: PE + PP two layer compound protective reinforcement with 100% white Terylene cuffs; Predicate 2: polypropylene/polyethylene protective reinforcement	air permeable membrane composite PE+ PP, double barrier non-woven fabric
Hydrostatic pressure: AATCC 127	Predicate 1: >20 cm; Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1)	>50 cm (This is significantly better than Predicate 1 and meets/exceeds the implied criteria for Predicate 2)
Impact penetration: AATCC 42	Predicate 1: ≤1; Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1)	≤1 (Meets criteria)
Biocompatibility	Predicate 1: not an irritant, not a sensitizer, non-cytotoxic; Predicate 2: not an irritant, not a sensitizer, non-cytotoxic	not an irritant, not a sensitizer, non-cytotoxic (Meets criteria for both)
Tensile strength: ASTM D 5034	Predicate 1: Length(lbf): 17.2, Width(lbf): 25.3; Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1)	Length(lbf): 17.7, Width(lbf): 25.7 (Slightly better than Predicate 1 and meets/exceeds implied criteria for Predicate 2)
Tearing strength: ASTM D 5733	Predicate 1: Length yarns torn(lbf): 4.5, Width yarns torn(lbf): 9.6; Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1)	Length yarns torn(lbf): 4.7, Width yarns torn(lbf): 9.8 (Slightly better than Predicate 1 and meets/exceeds implied criteria for Predicate 2)
Seam strength: ASTM D 1683	Predicate 1: Armhole seam (lbf) 17.4(F.B.), Shoulder seam (lbf) 9.4(F.B.); Predicate 2: Met acceptance criteria (Implied to be similar to or better than Predicate 1)	Armhole seam (lbf) 17.6(F.B.), Shoulder seam (lbf) 9.5(F.B.) (Slightly better than Predicate 1 and meets/exceeds implied criteria for Predicate 2)
Flammability: 16 CFR Part 1610	Predicate 1: Class 1; Predicate 2: Met acceptance criteria	Class 1 (Meets criteria)
Sterilization method	EO	EO
Resistance to blood and liquid penetration	Predicate 1: Level 4 per AAMI PB70; Predicate 2: Level 4 per AAMI PB70 (Note: The proposed device is Level 3, which is lower than the predicates. This could be a point of discussion for substantial equivalence, though the FDA cleared it.)	Level 3 per AAMI PB70 (This is lower than the predicate devices, which are Level 4. The FDA determines substantial equivalence based on the totality of the information, potentially considering if Level 3 is still sufficient for the intended use or if the predicate also had Level 3 models.)

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set used for each specific test (e.g., Hydrostatic pressure, Tensile strength). These are standardized tests, and the sample size would be defined by the relevant ASTM/AATCC standards.

The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective/prospective. However, given that XuChang ZhengDe Environstar Medical Products Co., Ltd is based in China, it is highly probable that the testing was conducted in China. The testing would be prospective for the purpose of demonstrating device performance to support the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes the performance testing of a physical medical device (surgical gown) against established engineering and material standards. Therefore, the "ground truth" is established by the results of physical and chemical tests performed by qualified technicians in accredited laboratories using the specified methodologies (e.g., AATCC 127, ASTM D 5034). There is no "ground truth" established by human experts in the way that would apply to imaging or diagnostic AI devices.

4. Adjudication Method for the Test Set

Not applicable for a physical device performance test. The results are quantitative measurements or classifications (e.g., Class 1 for flammability).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical device (surgical gown), not a diagnostic or AI-driven decision support system. Therefore, MRMC studies involving human readers and AI are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth is established through:

Performance against established industry standards: Such as AATCC 127 (Hydrostatic Pressure), AATCC 42 (Impact Penetration), ASTM D 5034 (Tensile Strength), ASTM D 5733 (Tearing Strength), ASTM D 1683 (Seam Strength), 16 CFR Part 1610 (Flammability), and AAMI PB70 (Resistance to blood and liquid penetration).
Biocompatibility testing: To demonstrate non-irritancy, non-sensitization, and non-cytotoxicity.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of physical medical device performance testing, as it does not involve machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 5, 2015

XuChang ZhengDe Environstar Medical Products Co., Ltd. c/o Mr. Mike Gu Regulatory Affairs Manager Osmunda Medical Device Consulting Co., Ltd. 7th Floor Jingui Business Building No. 982 Congyun Rd Baiyun District Guangzhou, Guangdong 510420 CHINA

Re: K141467

Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 6, 2015 Received: February 9, 2015

Dear Mr. Gu:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K141467

Device Name Surgical Gown

Indications for Use (Describe)

Models:

Standard surgical gown, model number: ZD2514, ZD2515, ZD2517, ZD2519 and ZD2520;
Reinforced surgical gown, model number: ZD2544, ZD2547, ZD2547, ZD2549 and ZD2550.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: 1. SUBMITTER

XuChang ZhengDe Environstar Medical Products Co.,Ltd

NO.3,Jinshui Road, Jinhui District, Yanling County, Xuchang City, 461200, Henan Prov., China

Phone: +86-575-88770363

Fax: +86-575-88084736

Mike Gu Primary Contact Person:

Regulatory Affairs Manager

OSMUNDA Medical Device Consulting Co., Ltd

Tel: (+86) 20-6232 1333

Fax: (+86) 20-8633 0253

Chen Ming Secondary Contact Person:

Quality Director

February 26, 2015

XuChang ZhengDe Environstar Medical Products Co., Ltd

Date Prepared:

DEVICE

Surgical Gown Name of Device:

Gown, Surgical Common/Usual Name:

Classification Names: Surgical apparel (21 CFR878.4040)

FYA

Regulation Class:

Product Code:

III. PREDICATE DEVICE

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Jiangsu Guangda Surgical Gown, Jiangsu Guangda Medical Material Co., Ltd, K121152.

GRI's Surgical Gowns, GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD, K102652.

These predicates have not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

Surgical gown 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

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Specification	Predicate Device	Predicate Device	Proposed
K number	K121152	K102652
Manufacturer	Jiangsu Guangda MedicalMaterial Co., Ltd.	GRI MEDICAL & ELECTRONICTECHNOLOGY CO., LTD	XuChang ZhengDe EnvironstarMedical Products Co., Ltd
Intended Use	Jiangsu Guangda's ReinforcedSurgical Gowns, Model NumberGD-SG-01,are non-sterile,singleusesurgical gownsintended to protect surgicalpatients and operating roompersonnel from the transfer ofmicroorganisms, body fluids,and particulate material.	GRI'sNon Reinforced,Reinforced, and Fabric ReinforcedSurgical Gowns are sterile or non-sterile, single use surgical gownsintended to protect surgical patientsand operating room personnel fromthe transfer of microorganisms, bodyfluids, and particulate material.	Surgical gown are devices thatare intended to be worn byoperating room personnelduring surgical procedures toprotect both the surgicalpatient and the operatingroom personnel from transferof microorganisms, bodyfluids, and particulatematerial.
Material	SMS	SMS	SMS
Weight per square (g)	45	50	45
Durability	Disposable	Disposable	Disposable
Size	XL	S, M, L, XL, XXL	M-S, M, L, XL, XXL

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Color	Blue	Various	Blue
Reinforced area	PE + PP two layercompound protectivereinforcement with 100%white Terylene cuffs	polypropylene/polyethyleneprotectivereinforcement	air permeable membranecomposite PE+ PP, doublebarrier non-woven fabric
Style	Reinforced	Reinforced and non reinforced	Reinforced and non reinforced
Hydrostatic pressure:AATCC 127	>20 cm	Met acceptance criteria	>50 cm
Impact penetration:AATCC 42	≤1	Met acceptance criteria	≤1
Biocompatibility	under the conditions of thestudy, not an irritant;under conditions of the study,not a sensitizer;under the conditions of thestudy the device is non-cytotoxic.	under the conditions of the study,not an irritant;under conditions of the study, not asensitizer;under the conditions of the studythe device is non-cytotoxic.	under the conditions of thestudy, not an irritant;under conditions of the study,not a sensitizer;Under the conditions of thestudy the device is non-cytotoxic.
Tensile strength: ASTMD 5034	Length(Ibf): 17.2Width(Ibf): 25.3	Met acceptance criteria	Length(Ibf): 17.7Width(Ibf): 25.7

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Tearing strength: ASTMD 5733	Length yarns torn(lbf): 4.5Width yarns torn(lbf): 9.6	Met acceptance criteria	Length yarns torn(lbf): 4.7Width yarns torn(lbf): 9.8
Seam strength: ASTM D1683	Armhole seam (lbf) 17.4(F.B.)Shoulder seam (lbf) 9.4(F.B.)	Met acceptance criteria	Armhole seam (lbf) 17.6(F.B.)Shoulder seam (lbf) 9.5(F.B.)
Flammability:16 CFR Part 1610	Class 1	Met acceptance criteria	Class 1
Sterilization method	EO	EO	EO
Resistance to blood andliquid penetration	Level 4 per AAMI PB70	Level 4 per AAMI PB70	Level 3 per AAMI PB70

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The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.

Therefore, the subject device is determined as safe and effectiveness.

VII. CONCLUSIONS

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XuChang ZhengDe Environstar Medical Products Co.,Ltd considers the Surgical Gown to be as safe, and as effective as the predicate devices. It does not raise any new issues of safety or effectiveness.

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.