No reference devices were used in this submission.
No
The device is a surgical gown, a physical barrier. The description and performance studies focus on material properties and barrier performance, with no mention of software, algorithms, or data processing related to AI/ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, a surgical gown, is intended for protection during surgical procedures, not for treating any condition.
No
Explanation: The device description states its purpose is to protect personnel and patients from contamination during surgery, not to diagnose a medical condition.
No
The device is a surgical gown, which is a physical garment made of fabric, not software. The description and performance studies focus on material properties and barrier performance, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Surgical Gown Function: The description clearly states that the surgical gown is intended to be worn by operating room personnel to protect both the patient and the personnel from the transfer of microorganisms, body fluids, and particulate material. Its function is a physical barrier, not a diagnostic test performed on a specimen.
- Lack of Diagnostic Elements: The description and performance metrics focus on material properties and barrier performance (hydrostatic pressure, tensile strength, resistance to penetration, etc.). There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, based on the provided information, the surgical gown is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of a caduceus, a symbol often associated with healthcare, with three intertwined snakes around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
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)
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.
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
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.
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 Medical | ||
| Material Co., Ltd. | GRI MEDICAL & ELECTRONIC | ||
| TECHNOLOGY CO., LTD | XuChang ZhengDe Environstar | ||
| Medical Products Co., Ltd | |||
| Intended Use | Jiangsu Guangda's Reinforced | ||
| Surgical Gowns, Model Number | |||
| GD-SG-01, | |||
| are non-sterile, | |||
| single | |||
| use | |||
| surgical gowns | |||
| intended to protect surgical | |||
| patients and operating room | |||
| personnel from the transfer of | |||
| microorganisms, body fluids, | |||
| and particulate material. | GRI's | ||
| Non Reinforced, | |||
| Reinforced, and Fabric Reinforced | |||
| Surgical Gowns are sterile or non- | |||
| sterile, single use surgical gowns | |||
| intended to protect surgical patients | |||
| and operating room personnel from | |||
| the transfer of microorganisms, body | |||
| fluids, and particulate material. | 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. | |||
| 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 |
ra
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| Color | Blue | Various | Blue |
|---|---|---|---|
| Reinforced area | PE + PP two layer | ||
| compound protective | |||
| reinforcement with 100% | |||
| white Terylene cuffs | polypropylene/polyethylene | ||
| protective | |||
| reinforcement | air permeable membrane | ||
| composite PE+ PP, double | |||
| barrier 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 the | ||
| study, not an irritant; | |||
| under conditions of the study, | |||
| not a sensitizer; | |||
| under the conditions of the | |||
| study the device is non- | |||
| cytotoxic. | under the conditions of the study, | ||
| not an irritant; | |||
| under conditions of the study, not a | |||
| sensitizer; | |||
| under the conditions of the study | |||
| the device is non-cytotoxic. | under the conditions of the | ||
| study, not an irritant; | |||
| under conditions of the study, | |||
| not a sensitizer; | |||
| Under the conditions of the | |||
| study the device is non- | |||
| cytotoxic. | |||
| Tensile strength: ASTM | |||
| D 5034 | Length(Ibf): 17.2 | ||
| Width(Ibf): 25.3 | Met acceptance criteria | Length(Ibf): 17.7 | |
| Width(Ibf): 25.7 |
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| Tearing strength: ASTM
D 5733 | Length yarns torn(lbf): 4.5
Width yarns torn(lbf): 9.6 | Met acceptance criteria | Length yarns torn(lbf): 4.7
Width yarns torn(lbf): 9.8 |
|-----------------------------------------------|----------------------------------------------------------------|-------------------------|----------------------------------------------------------------|
| Seam strength: ASTM D
1683 | 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 and
liquid 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
ು ಬ
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.